2006

November 2006

1st November 2006 - 3rd November 2006 at the Westin Horton Plaza in San Diego, CA, USA [927]
5th Annual Electronic Submissions Conference - eCTDs: Entering the Mainstream
In response to a growing demand for a comprehensive electronic submission conference, this year’s conference will be expanded to multiple tracks. As more and more companies gain experience or contemplate the transition to electronic submissions, and as the electronic submission environment changes, it is imperative that the stakeholders (agency, industry and service providers) maintain open communication regarding new regulations, guidance, and the experience of the implementation. This conference will focus on how to optimize the experience if you are just getting started, lessons learned for the experienced and more advanced, and how converging electronic standards and formats drive the future vision (5-year horizon) of interactions between the life sciences industry, regulators, and the public.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11208/06030.pdf

2nd November 2006 - 3rd November 2006 at the Westin Horton Plaza in San Diego, CA, USA [854]
4th Annual Electronic Submissions Conference - eCTDs: Entering the Mainstream
In response to a growing demand for a comprehensive electronic submission conference, this year’s conference will be expanded to multiple tracks. As more and more companies gain experience or contemplate the transition to electronic submissions, and as the electronic submission environment changes, it is imperative that the stakeholders (agency, industry and service providers) maintain open communication regarding new regulations, guidance, and the experience of the implementation. This conference will focus on how to optimize the experience if you are just getting started, lessons learned for the experienced and more advanced, and how converging electronic standards and formats drive the future vision (5-year horizon) of interactions between the life sciences industry, regulators, and the public.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11208/06030.pdf

2nd November 2006 - 3rd November 2006 at the Hotel Sofitel Paris Forum Rive Gauche in Paris, France [853]
DIA Pharmacovigilance WorkShop on: Safe Studies Throughout the Life Cycle - A Cradle to Grave Approach
The scrutiny and pressure on the pharmaceutical sector to deliver safe medicines has never been so great as it is now. This pressure comes from all directions: both enhanced compliance with more regulation and yet a demand for value for money from both governments and patients. This is against a backdrop of accusations of misconduct about financial inducement to change prescribing practices and encourage off label use. It is now urgent for the pharmaceutical sector to consider and explore how closer and active collaboration between stakeholders in marketed products may produce the best evidence so that we can deliver society’s Expectations about safety and effectiveness. Ideally, decisions about benefit-risk should be informed by patients’ outcomes in the real world.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11071/06113.pdf

2nd November 2006 - 3rd November 2006 at the Venue: The Rembrandt Hotel in London, UK [969]
CONDUCTING PRE AND POST MARKET MEDICAL DEVICE CLINICAL STUDIES
This course has been designed specifically for those involved in pre and post market studies wtihin the medical device industry. The device development process can be complex, costly and can take years to complete. The collection of clinical data to demonstrate safety and performance of a device is pivotal to the development process and necessary for regulatory approval. The collection of post market data is a key aspect of continued safety and performance considerations once the device is on the market. This course willl cover the full range of clinical research activities taht should be applied during the collection of data for both pre- and post market studies. It will provide delegates with information on the European regulations for conducting medical device studies and help them to run studies in Europe. Delegates should benefit from the advice and tips on the practicalities of conducting studies within Europe. There will be ample time for case studies and group discussions.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=526

5th November 2006 - 8th November 2006 at the Congress Center in Basel, Switzerland [855]
DIA Multi-Track Conference on CDM, eClinical & Clinical Research "The Changing World of Clinical Trials
The clinical trials process is undergoing a technology revolution. Our roles in support of clinical trials, be it investigator, study manager, monitor or data manager, are changing. Is technology driving the practice or do new clinical processes sufficiently influence the development and adoption of electronic submission? This conference is designed to address these issues by providing a unique forum that brings all clinical development professionals together. The Multi-Track format of this event will facilitate refreshing debate amongst all parties involved with clinical trials from the Investigator Site to database closure. We welcome your support.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/10452/call%20for%20abstract%2006109.pdf

5th November 2006 - 8th November 2006 at the Congress Center in Basel, Switzerland [928]
The Changing World of Clinical Trials - European Clinical Research Conference, European eClinical Conference, 16th Annual European CDM Conference
The clinical trials process is undergoing a technology revolution. Our roles in support of clinical trials, be it investigator, study manager, monitor or data manager, are changing. Is technology driving the practice or do new clinical processes sufficiently influence the development and adoption of electronic submission? This conference is designed to address these issues by providing a unique forum that brings all clinical development professionals together. the Multi-Track format of this event will facilitate refreshing debate amongst all parties involved with clinical trials from the Investigator Site do database closure. We welcome your support.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/10452/call%20for%20abstract%2006109.pdf

6th November 2006 - 7th November 2006 at the Washington Marriott Hotel in Washington, DC, USA [934]
A Critical Path Approach to Rapid Diagnostics Development and Infectious Disease Treatment
The rapid diagnosis of infectious disease has never been more important or relevant. In addition to urgent medical and public health needs posed by emerging infectious diseases (SARS, avian influenza) and bioterrorism, more rapid and accurate diagnosis of infectious diseases can lead to targeted and more efficient treatments with improved outcomes. The concept of matching a therapeutic entity with diagnostic testing, can ensure the right drug, at the right level, for the right indication, for the right patient, at the right time. Application of new technology for diagnostic uses offers tremendous potential for changing practice paradigms. New methods in molecular diagnosis, new information on genomics, proteomics and the biologic basis of infection, along with improvements in portability, robustness, and connectivity have made diagnostic windows possible that would not have even been considered before. Integrating and coordinating multiple facets of today’s healthcare system has been slow and is the fundamental challenge for change. This workshop focuses on approaches to shorten the critical path in new product development and integrating new technology into clinical practice. It will also focus on transitioning new diagnostic tests from the research bench to the laboratory and near-patient settings.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11361/06033.pdf

6th November 2006 - 8th November 2006 at the Venue: The De Vere Cavendish Hotel in London, UK [970]
PHARMACEUTICAL REGULATORY AFFAIRS IN LATIN AMERICA - Brazil, Peru, Ecuador, Mexico, Argentina, Chile, Venezuela, Colombia, Central America
Day 1: Brazil - Peru - Ecuador Day 2: Mexico - Argentina - Chile - Venezuela Day 3: Colombia - Central America - Harmonisation Efforts in Latin America This seminar will provide up-to-date coverage of the requirements that underpin a successful pharmaceutical and cosmetic products marketing authorisation application across Latin America. In a carefully structured programme, speakers will cover the official regulatory sources but will also share the interpretation and alternatives to local/specific legal requirements that only people with hands on experience in the region can provide. The seminar will also include an overview of the regulatory aspects of: site inspection, clinical trials, package labelling and the requirements for the marketing of Generic drugs, OTC medicines and Diagnostic kits. By the end of the seminar, during the interactive workshop, the participants will be invited to put learning into practice through the resolution of case studies. It is anticipated that the seminar will be useful both as an inventory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject areas.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=325

7th November 2006 - 10th November 2006 at the Hall 2-7 Beijing China International Exhibition Center in Beijing, China [697]
The 11th China International Pharmaceutical Industry Exhibition
The 11th Anniversary Ceremony of China International Pharmaceutical Industry Exhibition (China-Pharm) will be held in Beijing, China, in the autumn of 2005. Since its debut in 1996, the actual exhibition area of CHINA-PHARM keeps increasing by 20% at each event, the actual amount of transaction at each event is also increasing year by year. And the number of visitors/time reaching nearly 40,000. Exhibition Scope?? Medicine Machinery and equipment for pharmaceutical raw materials Preparation machinery Pharmaceutical milling machinery Slicing machinery for herbal medicine Water treatment equipment for pharmaceutical use Pharmaceutical packaging machinery Medicine testing instruments Other pharmaceutical machinery and equipment on-spot cleaning & sterilizing equipment, Packaging material Service Publication Analytical instruments life science instruments, instruments for environmental protection, laboratory equipment, food analysis instruments chemical reagents Safe Food Manufactory Safe Food Packaging
Contact: April Yu
Telephone: 86-21-62797338; Fax: 86-21-62797337
Email: chinapharm@mdc.com.cn
Website: http://www.chinapharmex.com/

7th November 2006 at the Online in Online, USA [1056]
Beyond 2006 - Software and Services Trends for eClinical Trials
This web seminar will serve as a prelude to DIA’s conference, The Quest to Enable the Electronic Clinical Trial: Finding Clarity in a Confusing World taking place on December 6-7, 2006 in Baltimore, MD.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12332/06251.pdf

8th November 2006 - 10th November 2006 at the EMEA in Canary Wharf, London, United Kingdom [856]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
The primary goals of this course are to allow participants to: •Acquire a robust base in the fundamentals of the electronic reporting of ICSRs •Familiarise themselves with the electronic transmission of ICSRs and the ICH M2 safety and acknowledgment message specifications •Understand and apply the ICH E2B(M) specifications on clinical safety data management in the frame of good pharmacovigilance practices •Get hands on experience with the EudraVigilance reporting capabilities and query functions •Understand the concepts of the EudraVigilance Medicinal Product Dictionary and get some practical experience in working with it.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9410/06523.pdf

8th November 2006 - 10th November 2006 at the Venue: The Rembrandt Hotel in London, UK [972]
US PATENT PRACTICE - What Every European Practitioner Should Know
US and European patent practice differs in many essentials. This seminar is divided into three elements, which can be attended singly or together. The programme, with practical examples, will cover: a) Patent claim drafting, sufficiency of disclosure and claim interpretation, b)Statutory patent law and patent prosecution and c) Patent litigation, appeals, interferences, re-examinations and reissues. The course will give delegates a clear explanation of the US Patent system, enabling them to work more effectively with their US counterparts.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=98

8th November 2006 at the Venue: The Rembrandt Hotel in London, UK [971]
THE PERFECT MEDICAL DEVICE CLINICAL INVESTIGATION PLAN - How to Develop and Write a Clinical Investigation Plan for a Medical Device Study
The Clinical Investigation Plan/Protocol is a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical study and is regarded as an essential document. This practical workshop will take you through the evolution of a protocol from a primitive state to the final comprehensive document. There will be ample time for case study exercises and group discussions. Through this combination of presentations and exercises, delegates will learn how to put a Protocol together, what the usual pitfalls are and how to overcome them.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=506

9th November 2006 at the Venue: The De Vere Cavendish Hotel in London, UK [975]
THE MANAGEMENT OF COPD AND ASTHMA
This conference will explore further our current understanding of the management of COPD and ASTHMA. These respiratory diseases cause more deaths in the UK than any other disease area, which in turn cause heavy social and economic burdens. We are bringing together acknowledged experts from academic, regulatory authorities and the pharmaceutical industry to discuss some exciting new avenues for therapeutic research
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=547

9th November 2006 - 10th November 2006 at the Venue: The Rembrandt Hotel in London, UK [974]
LEADING SUCCESSFUL PHARMA TEAMS - Maximising your Team Leadership skills
This intensive course equips team leaders with the practical tools and techniques to develop high-performing teams which maximise performance and deliver results. Working in the Pharmaceutical and Device industries has become increasingly challenging and fast moving. Previously, excellence in technical areas would have guaranteed a successful career. In future, to develop and even sustain your career you almost certainly will need to gain and build your team leadership skills in order to perform in your existing role or to gain promotion. Technical skills alone are unlikely to do this. Have you or your manager identified this need for you - to be a stronger leader?
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=530

9th November 2006 at the Venue: Harrington Hall in London, UK [973]
EFFECTIVE RECALL MANAGEMENT - For Pharmaceutical, Biotechnology, Veterinary & Fine Chemicals Industries, London
A Recall from the marketplace of a successful pharmaceutical product can be a significant challenge to even the best of companies. Incorrectly managed, it can result in a loss of confidence by the purchasing pharmacist/hospital and more importantly the re-establishing of a dependent patient on another formulation while the recall is in effect. From an industry perspective, it is important to ensure that all aspects of the Recall Procedure (from initial risk assessment, event investigation, the Recall Strategy and subsequent corrective and preventative actions) work smoothly and effectively. This seminar will discuss and address the various elements involved with Recall, how they can be managed effectively and what is required to enable a systematic approach to ensuring that the re-occurence of the event is minimised and/or eliminated.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=411

9th November 2006 - 10th November 2006 at the Venue: Hotel Ambassador in Barcelona, Spain [977]
BRAILLE REQUIREMENT FOR MEDICINAL PRODUCTS
12 months after the implementation of the EU requirements for Braille to be on the labelling of medicinal products and for patient information to be available in formats to suit the blind and partially sighted, it is time to review what has happened, understand some of the difficulties and learn by sharing experiences. Problems have arisen in understanding some of the requirements and how they can be put into practice. In addition to traditional technology, new technology is being introduced and there have been potential GMP issues. Braille on some packaging (pharmaceutical and non-pharmaceutical alike) is not readable because the impression is inadequate. This is a potential risk for patients and could result in Regulatory action. Associations working for the blind are seeking a high level of Braille readability.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=412

9th November 2006 - 10th November 2006 at the Venue: The De Vere Cavendish Hotel in London, UK [1028]
CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND ASTHMA
Respiratory disease causes more deaths in the UK than any other disease area. Chronic Obstructive Pulmonary Disease (COPD) and ASTHMA are common disorders which cause heavy social and economic burdens. This annual conference will explore further current understanding of the management of COPD and ASTHMA, and will bring together acknowledged experts from academic, regulatory authorities and the pharmaceutical industry to discuss some exciting new avenues for therapeutic research.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=550

13th November 2006 at the Venue: Harrington Hall Hotel in London, UK [978]
GENERIC MEDICINES in EUROPE: LAW, REGULATION & MARKETPLACE
The impact of generic medicines on the pharmaceutical industry as a whole would be hard to overstate. It is the inevitable launch of generic medicines that limits the profitable life of Big Pharma's blockbusters - indeed, having a spate of products becoming open to generic competition simultaneously can bring even the most solid blue-chip giant to its knees. And with ever-growing concerns about the spiralling costs of medicines, it seems that governments across the globe are increasingly seeing generic medicines as a cost-limiting solution, with active steps being taken in many countries to encourage their generics markets. Furthermore, if the problems holding back the entry of biogenerics into the picture can be overcome, the impact of generics will be felt in areas of the industry hitherto untouched. This meeting aims to explore some of the core aspects and key drivers in the generics industry. As well as an overview of the commercial realities of generics market, the all-important legal aspects that govern the market - and determine whether generic competition is possible or not - will be examined. There is also an examination of the interplay between the two and how the regulatory side does not exist in isolation from the commercial but has a direct impact on it. The particular features of the regulation of small-molecule generics will be discussed in detail, and finally the rapidly developing area of biogenerics will be explored. As is vital for any discussion of a fast-changing field such as this, all speakers will look to the future as well as to the present, to explore likely course of the ongoing evolution of the generics industry.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=311

13th November 2006 - 16th November 2006 at the Crowne Plaza Union Square in San Francisco, CA, USA [857]
The Leadership Experience
The Leadership Experience is a 3 1/2-day session in which participants, working in a group, assume senior management roles. They analyze information, make decisions, and deal with the consequences of their decisions. There is special emphasis on the skills required to establish cooperation, diagnose and correct dysfunctional groups, and combine the skills of multiple people to accomplish what cannot be done alone. This is a VERY intensive program designed for those who are serious about improving their leadership skills.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9279/06405.pdf

13th November 2006 - 14th November 2006 at the Hyatt Regency Washington on Capitol Hill in Washington, DC, USA [858]
European Regulatory Affairs
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 1995. It reviews Centralized, Mutual Recognition, and national registration procedures in detail, and includes practical examples of product types particularly suited to each procedure. There will also be a discussion on the new medicines legislation, which is effective November 2005, and how it changes access to centralized procedure and alters regulatory data protection. Key Topics •Centralized, Mutual Recognition and National Registration Procedures in the EU. •Official regulatory policies and other issues pertinent to successful EU regulatory strategy. •EU regulatory strategy pertinent to commercial, business, and licensing arrangements. •Trademarks and patents. •Medical devices. •Clinical Trial Directive. •Legal status and switching.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9319/06411.pdf

13th November 2006 at the Hilton Inn at Penn in Philadelphia, PA, USA [859]
Overview of Drug Development
This course provides an overview of how new pharmaceutical products are identified and developed. The roles and interactions among marketing, clinical R&D, regulatory affairs, and manufacturing will be reviewed. A basic description of the Investigational New Drug Application (IND) will lead to a review of how clinical trials are started, completed, and reported; ethical considerations in conducting clinical research; filing a New Drug Application (NDA) and interactions with the FDA. The course material focuses on developing drugs and biologics under FDA regulations and ICH guidelines. Key Topics: •How the pharmaceutical industry identifies new products and brings them to market. •Contributions of key groups within the company and how they interact. •FDA and regulation of the industry.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9333/06423.pdf

13th November 2006 - 17th November 2006 at the Charleston Place in Charleston, SC, USA [863]
Investigational Supply Process Training Course
This course is designed to provide an understanding of the many details to consider in the design, preparation, and packaging of clinical trial materials within the regulatory framework of disciplined clinical studies. The course encourages interaction and participation through small group case studies and roundtable discussions that emphasize the key concepts underlying the planning, implementation, and logistics of clinical supply projects. Key Topics •Techniques That Streamline The Clinical Supply Process •Interrelationships of the clinical supply pharmacist, clinical research associate, medical monitor, regulatory professional, compliance officer, clinical pharmacist, and quality assurance auditor •Current Good Manufacturing Processes (cGMP) and Good Clinical Practices (GCP) concepts applicable to the investigational supply process •Sponsor obligations during the preparation, use, and return of investigational materials.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11169/06451ISP.pdf

13th November 2006 - 15th November 2006 at the Washington Marriott Hotel in Washington, DC, USA [861]
Regulatory II: The CTD/NDA Phase
The course will focus on drug and well-characterized biological products, and not the regulatory process for devices or generic products, or the abbreviated NDA. This course describes the regulatory background of the NDA and provides an overview of preparing an NDA in CTD format for submission to the FDA. Key Topics •Overview of FDA. •Roles and responsibilities of FDA. •Regulatory requirements for drug approval. •Pertinent regulatory processes and forms. •Overview of the CTD format. •Post-approval and marketing regulatory requirements and processes.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9398/06433%20November%20update.pdf

13th November 2006 - 14th November 2006 at the Hilton Philadelphia City Avenue hotel in Phyladelphia, USA [919]
e-Communication and Online Marketing Conference
Whether your company has recently started its web activities or is improving its advanced online features, the e-Communication and Online Marketing Conference will help you discover how and why the new communication paradigms and techniques will increase your products awareness, improve your interaction with customers and build and foster a sense of community among your clients and partners. The e-Communication and Online Marketing Conference (13 th -14 th of November, Philadelphia) has the ambitious aim of constituting a unique platform for discussing, understanding and evaluating what New Technologies can do for the Pharma sector and how Information and Communication Technologies can make a difference for your company's growth.
Contact: Alice Pilia Conference Director
Telephone: Toll Free USA: 1 800 814 3459 x 292; Fax:
Email: apilia@eyeforpharma.com
Website: http://www.eyeforpharma.com/edetailusa/index.shtml

14th November 2006 - 17th November 2006 at the 30 Pavillion road in London, United Kingdom [798]
the 4-day Pharma MBA
A 4-day practical and interactive programme developing the high performance manager in the pharmaceutical industry.
Contact: Sonia Tavanai Tamanai
Telephone: +44 (0)207 749 4747; Fax: +44 (0)207 7296110
Email: sonia.tavanai@falconbury.co.uk
Website: http://www.falconbury.co.uk/event

14th November 2006 at the Venue: Harrington Hall Hotel in London, UK [980]
POST CONFERENCE WORKSHOP: ACCELERATING THE REGISTRATION PROCESS - A workshop discussing the Importance of Regulatory Processes to Commercial Success
The impact of generic medicines on the pharmaceutical industry as a whole would be hard to overstate. It is the inevitable launch of generic medicines that limits the profitable life of Big Pharma's blockbusters - indeed, having a spate of products becoming open to generic competition simultaneously can bring even the most solid blue-chip giant to its knees. And with ever-growing concerns about the spiralling costs of medicines, it seems that governments across the globe are increasingly seeing generic medicines as a cost-limiting solution, with active steps being taken in many countries to encourage their generics markets. Furthermore, if the problems holding back the entry of biogenerics into the picture can be overcome, the impact of generics will be felt in areas of the industry hitherto untouched. This meeting aims to explore some of the core aspects and key drivers in the generics industry. As well as an overview of the commercial realities of generics market, the all-important legal aspects that govern the market - and determine whether generic competition is possible or not - will be examined. There is also an examination of the interplay between the two and how the regulatory side does not exist in isolation from the commercial but has a direct impact on it. The particular features of the regulation of small-molecule generics will be discussed in detail, and finally the rapidly developing area of biogenerics will be explored. As is vital for any discussion of a fast-changing field such as this, all speakers will look to the future as well as to the present, to explore likely course of the ongoing evolution of the generics industry.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=548

14th November 2006 at the Venue: Harrington Hall Hotel in London, UK [981]
THE ROLE OF THE QUALIFIED PERSON IN PHARMACOVIGILANCE - Implications of Volume 9A
Each Marketing Authorisation Holder placing medicinal products on the European Union market should have in place a Qualified Person for Pharmacovigilance. Experience during recent regulatory inspections indicated that there is now greater emphasis being placed on the role of the Qualified Person for Pharmacovigilance within the EU, with significant penalties liable to be imposed for non-compliance with this requirement. This seminar will offer guidance from members of Industry and the Regulators as to the requirements, including proposed updates in Volume 9a of the Notice to Applicants, and examples given of role models used in different sized companies. Special problems will be discussed, with practical advice as to fulfilling the legal requirements
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=534

14th November 2006 - 16th November 2006 at the JW Marriott Hotel in Dubai, United Arab Emirates [864]
DIA 7th Middle East Regulatory Conference (MERC)
Since its inception nearly 10 years ago, the Middle East Regulatory Conference has grown to become an important forum for discussion of matters related to the provision of healthcare in the region, with a specific focus on issues around the evaluation and supervision of medicines for human use. The conference offers the opportunity for key stakeholders active in the region, including representatives from ministries of health, local and multinational pharmaceutical companies, to meet to exchange views, discuss topics of interest and identify actions to increase patient access to new and improved medicines and therapies. Key Issues •Updates on global regulatory developments. •EU New Medicines Legislation and how it will impact regulatory requirements. •Clinical trial data availability Middle East Regional Regulatory Developments (including GCC-DR update). •Importance of product lifecycle management. •Procedural aspects of variations systems. •Procedural aspects of urgent/non-urgent labelling changes. •Pharmacovigilance - mechanisms for gathering and disseminating data. •Elements of quality review in the Middle East.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6100
Email: dia@diahome.org
Website: http://www.diahome.org/product/9267/06104.pdf

15th November 2006 - 15th December 2006 at the The Great Room, Grosvenor House Hotel in London, UK [875]
Scrip Awards 2006
The Scrip Awards recognise individuals and companies who have made an outstanding contribution to furthering the goals of their organisation and improving global health. Winning an award is the mark of global distinction and is the highest level of professional acknowledgment within the pharmaceutical and biotechnology industries today. To sponsor an award, enter or reserve your seat please contact Charlotte Garratt mailto:charlotte.garratt@informa.com
Contact: Charlotte Garratt
Telephone: +44 (0)20 7017 5173; Fax: +44 (0)20 7017 6787
Email: charlotte.garratt@informa.com
Website: http://www.scripawards.com/

16th November 2006 - 17th November 2006 at the Venue: The Rembrandt Hotel in London, UK [983]
PATENT SYSTEMS IN EUROPE - A Schematic Overview
This valuable two-day course aims to provide a unique schematic overview of the multinational aspects of the Patent System in Europe, with selected topics being discussed in depth A brief outline of the various patent-related international treaties in force will be followed by a more detailed examination of both the European Patent Convention (EPC) and the Patent Cooperation Treaty (PCT). The interface between the two systems will be explained. The forthcoming changes to the EPC and the PCT Rules will also be outlined.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44(0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=514

21st November 2006 at the Venue: The Rembrandt Hotel in London, UK [985]
DRAFTING INTELLECTUAL PROPERTY AGREEMENTS IN THE BIOTECH AND PHARMACEUTICAL INDUSTRIES - Drafting skills and legal and commercial issues
The course will focus on drafting skills and legal and commercial issues affecting a range of agreements that concern intellectual property within the pharma/biotech industries, including confidentiality agreements, material transfer agreements, term sheets, IP licences and assignments and IP terms in R&D contracts. Practical exercises and discussion
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=489

21st November 2006 at the Venue: The De Vere Cavendish Hotel in London, UK [984]
REGULATORY UPDATE ON ANIMAL FEED ADDITIVES
As a result of the EU White Paper on Food Safety published in 2000, there have been sweeping changes to legislation concerning the food chain, especially feed and feed additives. The EU feed additive regulation (EC No. 1831/2003) replaced the existing feed additive Directive 70/524/EEC and introduced a new system for assessing feed additive dossiers. The new evaluation procedure involves the EU Commission, EFSA (European Food Safety Authority) and the Standing Committee on the Food Chain and Animal Health, which includes delegations from 25 EU Member States. The EU plans to review all currently authorised feed additives within the next decade, most likely starting with groups of additives that are considered to represent a potential safety hazard to animals, workers, consumers or the environment. Many existing feed additives have never before been subjected to an EU assessment according to current standards of safety, quality and efficacy.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=504

22nd November 2006 at the Venue: The Rembrandt Hotel in London, UK [986]
MANAGING SUCCESSFUL EU FEED ADDITIVE EFFICACY TRIALS
The new feed additive Regulation (EC) 1831/2003 lays down the procedure for approval of feed additives intended for placing on the EU market.The approval process requires demonstration of the efficacy of the additive in relation to feed characteristics, animal nutrition, produce or performance, or the environment. Hisotomonstats and coccidiostat feed additives must also demonstrate efficacy under defined conditions. Silage agents, amino acids and urea are considered as feed additives for the first time.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=505

23rd November 2006 - 24th November 2006 at the Venue: The Rembrandt Hotel in London, UK [987]
RISK MANAGEMENT OF MEDICAL DEVICES AND EU VIGILANCE
The safety and risk management of medical devices are becoming ever more important issues to be addressed by manufacturers. In addition Post Market Surveillance (PMS) and Vigilance are very significant elements of risk management. What effect will the current review of the Medical Device Directives have on risk management and analysis? Standards change, expectations increase and information is now more available and transparent. The recent increase in FDA product recalls highlights the necessity to have an established risk management system in place. This interactive seminar will look at the risk management standard, product liability, biological safety, PMS and will also provide a detailed practical opportunity to learn the various ways in which a risk analysis may be performed. Understanding how to manage risk is paramount to the success of a medical device company.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=507

24th November 2006 at the Venue: The De Vere Cavendish Hotel in London, UK [988]
ADVANCED FORMAL REQUIREMENTS OF EPO for administrative staff and paralegals
This course has been designed to give a practical, in-depth understanding of the inner workings and finer details of the formal requirements of proceedings before the European Patent Office. Apart from addressing very specific items of procedure, participants will be given the opporunity to raise specific problems, and practical solutions will be put forward and discussed. It is for those who have extensive experience of filing before the EPO or who have attended the Management Forum course Guide to the Formal Requirements of the European Patent System.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=110

27th November 2006 - 29th November 2006 at the The Moller Centre in Cambridge, UK [925]
Tabletting Technology for the Pharmaceutical Industry
This well-established course provides an intensive course of study on the formulation, production and drug-release characteristics of pharmaceutical tablets. The course will cover the basic concepts of equipment selection, granulation and end-point determination, formulation optimisation and prediction, in-process monitoring (PAT), official and non-official dissolution tests, and film coating. It deals with development pharmaceutics for registration. The lectures will describe the current state of knowledge of the subject, both in terms of theoretical basis and practical experience. The workshops provide opportunities for discussion in small groups of real-life problems encountered in tabletting and will draw on a sound theoretical knowledge of the principles involved in the processes.
Contact: Lisa Gilbert
Telephone: 020 7572 2261; Fax: 020 7572 2506
Email: science@rpsgb.org
Website: http://www.rpsgb.org.uk/pdfs/scires0611.pdf

27th November 2006 at the Venue: The Rembrandt Hotel in London, UK [989]
DATA PROTECTION ISSUES IN THE PHARMACEUTICAL INDUSTRY
Legislation on data protection is having a significant impact on the work of the pharmaceutical, industry. The seminar will examine the effects European and UK Laws will have on clinical development , market support of new medicines and pharmacovigilance. Topics will include the philosophy and objectives of the European Data Protection Directive, the UK Data Protection Acts, the concepts of the consent, processing, sensitive data, safe havens, the types of research affected by data protection as well as strategies for the future. The relationship between data protection and intellectual property will also be covered
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=531

27th November 2006 - 28th November 2006 at the Washington Marriott Hotel in Washington, DC, USA [967]
Best Practices and Development of Standards for the Submission of Genomic Data to the FDA
This two-day workshop includes a series of presentations pertaining to the present state of the Best Practices Document, as well as what can be expected once the document becomes final later this year. Topics will include: • Scientific accomplishments showcased in Voluntary Genomic Data Submissions (VGDS) over the past two years. • Consensus from Q&A sessions about the added value of genomic data in regulatory review. • New applications associated with VGDS, including other omic platforms and estimates for the impact of pharmacogenomic information in clinical trials. • Role of VGDS in the Biomarker Qualification Pilot Process. • Best Practices and Development of Standards in the Submission of Genomic Data to the FDA. SPECIAL FEATURES Spirited discussion of the VGDS experience Breakout sessions to discuss best practices and standards in the submission of genomic data.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12225/06036.pdf

27th November 2006 - 28th November 2006 at the Renaissance Paris Hotel La Defense in Paris, France [865]
European Regulatory Affairs
The workshop will provide strategic advice on how to file applications for the marketing authorizations in the European Union for staff involved in International Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development. Key Topics •European Union. •Centralized Procedures. •DeCentralised Procedure. •Mutual Recognition Procedure. •National Procedure. •Key Issues to Consider for Business Opportunities. •Regulatory Strategy. •Legal Status of Products and Switching from Rx to OTC. •Medical Devices Legislation. •Clinical Trial Directive.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9224/06505.pdf

27th November 2006 - 1st December 2006 at the Renaissance Paris Hotel La Defense in Paris, France [841]
Pharmacovigilance Training: Clinical Trials and Marketed Products
This course is designed to provide a firm grounding in key aspects of Global Clinical and Post Marketing Safety. This five-day training course, presented by EMEA, is the only one of its kind. Key Topics: Definitions and Methods in Pharmacovigilance. Regulatory Aspects in Pharmacovigilance and Practical Examples. Diagnosis and Management of Adverse Drug Reactions. Risk Management.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11005/06537.pdf

28th November 2006 at the Venue: Harrington Hall Hotel in London, UK [990]
PHARMACOVIGILANCE ASPECTS OF LICENSING AGREEMENTS - Essential for those involved in Drug Safety & Licensing Agreements
Whilst licensing agreements involving pharmaceuticals are primarily driven by commercial considerations, the successful handling of the pharmacovigilance and safety data exchange sections of the contract is a critical, but frequently overlooked, consideration. Negotiating the safety arrangements of the agreement to ensure compliance by both partners can be a complex process. This is further compounded by lack of harmonisation and clarity of the regulations around the world. This seminar will review the existing global requirements relating to pharmacovigilance in contractual agreements and will offer guidance from members of industry and the regulators, with examples of different role models used by companies from the three ICH regions. The emphasis will be on practical advice as to how to remain compliant with the legal requirements as well as how to promote harmonious business partnerships
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=535

28th November 2006 at the Venue: Harrington Hall Hotel in London, UK [991]
THE NEW ROUTES TO REGULATORY APPROVAL IN EUROPE ~ ONE YEAR ON - What are the Key Strategic and Practical Issues
The implementation of the new European Pharmaceutical Legislation in October 2005, introduced significant changes to the regulatory routes to approval of medicinal products in the European Union. The new Decentralised Procedure was established and significant changes have been made in the operation of the Mutual Recognition Procedure. Within the scope of the New Pharmaceutical Legislation an ever increased focus has been placed on the Centralised procedure with a number of changes being implemented to facilitate faster access to new innovative medicines. To be successful in this new Regulatory environment it is important for the pharmaceutical industry to understand the strategic and practical issues that have arisen from the implementation of the new legislation. One year on the purpose of this meeting is to reflect on the experience gained to date. In so doing, the meeting will examine the key legislative changes in the routes to regulatory approval in the EU and will provide an understanding of the strategic and practical issues and opportunities that result. Perspectives from the Regulators and Industry will consider practical advice on how to run a successful Decentralised Procedure, changes to the Mutual Recognition Procedure, impact for generic products and the new opportunities provided within the Centralised procedure.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=532

28th November 2006 - 29th November 2006 at the Venue: Harrington Hall Hotel in London, UK [993]
CALIBRATION MANAGEMENT
This seminar will discuss the contents of the 'Good Practice Guide - Calibration Management'.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=447

29th November 2006 - 30th November 2006 at the Doubletree Hotel Philadelphia Philadelphia, PA in Philadelphia, PA, USA [964]
5th Annual Contract Manufacturing for Pharmaceuticals: Optimizing Outsourcing Relationships to Ensure Quality and Profitability
Contract Manufacturing for Pharmaceuticals will teach you proven strategies for outsourcing your manufacturing functions. Attend this conference to learn from industry leaders about: · Selecting the right contract manufacturing organization (CMOs) ·Developing quality agreements ·Managing and tracking performance ·Building relationships with CMOs ·Assuring quality of product This conference was developed with your specific challenges in mind. A unique panel discussion has been created based on your feedback. Attend this conference and hear from WATSON PHARMACEUTICALS, ABBOTT LABORATORIES, and MERCK & CO, INC. about their experiences in working with CMOs.
Contact: Erica
Telephone: ; Fax:
Email: ecrowder@iqpc.com
Website: http://www.iqpc.com/na-10854-001/ediary

29th November 2006 at the Online in PA, USA [1088]
FDA Withdraw of Three Guidances for eSubmissions
Learn Why the FDA Withdrew Three Guidances for eSubmissions On September 29, 2006, the FDA’s Center for Drug Evaluation and Research announced the withdrawal of three guidances for eSubmissions. These Guidances covered: •New Drug Applications (NDAs) •Abbreviated New Drug Applications (ANDAs) •Annual Reports for NDAs and ANDAs WEBINAR HIGHLIGHTS •Why previous guidances are no longer consistent with more recent guidances •Why they no longer reflect the Center’s preferred format for receiving electronic submissions •Why the eCTD format is now preferred by the FDA.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12421/06252.pdf

29th November 2006 at the Venue: Harrington Hall in London, UK [994]
HVAC FOR PHARMACEUTICAL MANUFACTURING
The manufacture of pharmaceutical products requires specialised and controlled environments and the HVAC System is the control of these environments. This seminar will review the types of systems and the nature of the HVAC Systems for a wide range of dosage forms.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=414

29th November 2006 at the Venue: To be announced in London, UK [995]
INJECTABLE AESTHETICS - Skin Rejunvenation
In this workshop you will learn the advanced techniques in total lip contouring, facial contouring, asymmetric balancing, non surgical brow lift, filler techniques to give a youthful face and more. This will include a special segment on skin-rejuvenation with the latest intradermal techniques with Hyaluronic Acid
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=544

30th November 2006 - 1st December 2006 at the Venue: Harrington Hall Hotel in London, UK [996]
MEDICAL DEVICE REGULATION IN JAPAN, GREATER CHINA (PRC), HONG KONG
Now that the Europoean Medical Device market is well established, the new growth area is Japan. Japan, China, Taiwan, Hong Kong and other countries have all implemented , or are in the process of implementing, their own medical device regulations and developments in these countries and give practical guidance on how to comply with the requirements and gain access to these growth markets.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=524

December 2006

1st December 2006 at the Venue: The Rembrandt Hotel in London, UK [997]
HIGH PERFORMANCE BUSINESS SKILLS FOR PHARMA SUPPORT STAFF
This enjoyable one day course will help you work more efficiently and gain greater credibility in todays pharmaceutical industry. You wil have a greater understanding of the business jargon and how to achieve your potential whilst adding value to your organisation. You will also learn to organise your thinking more effectively, present your ideas and communicate more effectively. You will be able to show greater iniative and come across with more professionalism so as to be able to take a great responsibility in your organisation.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=539

3rd December 2006 - 5th December 2006 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [932]
Are Your Intellectual Assets at Risk? Leveraging knowledge management and legal strategies to address the tension between the dissemination and protection of scientific information
Knowledge Management (KM) is an integrated approach to identifying, managing, and sharing a company’s knowledge-based intellectual assets. As an industry sector dependent on innovation, embedding best practice in KM is key to ensuring continued success. While technology is an important enabler, addressing a knowledge culture and process is currently the greatest challenge. How far should we go? Should we seek to control and direct what people have come to know, what they have delivered as output and then enable it to be securely distributed? KM enables more efficient and effective team-based communication, cooperation and collaboration. The value of intellectual assets is a function of their ability to be shared – but to the right people at the right time; managing their security while providing appropriate distribution is a major challenge and needs clear management structures to ensure that there is responsibility for managing these assets. As companies increasingly seek to globalize their business models, the challenges we face are multiplied; language, time zone, and cultural differences are just some examples. Current and emerging knowledge management systems coupled with a clear legal strategy, business process model and management focus can substantially minimize these challenges.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11204/06031.pdf

3rd December 2006 - 5th December 2006 at the Shores Resort & Spa in Daytona, Florida [931]
FUTURE PHARMA CONGRESS
Who should attend? C-Level Executives representing the Pharmaceutical Manufacturing Industry and related areas. Details: On December 3rd 4th and 5th in Daytona, Florida, some of the world’s top executives in the pharmaceutical industry are coming together. For 3 days of Keynote presentations, workshops and panel discussions, designed to help facilitate the advances that need to be made in order for these organizations to remain innovative and at the forefront, within their markets. Pharmaceutical Congress Quick Facts: •Title: The Future Pharmaceutical Congress •Private | Invitation Only Corporate Event •Link attending speakers thus far: http://virtusinternational.com/pharma/speakers.html •Date: December 3-4-5, Daytona, Florida Delegation includes 150 VP and C-Level Executives representing the Pharmaceutical Manufacturing Industry. Also included a link to our past speakers for Medial Device and R&D forum we produced this past March: http://virtusinternational.com/medical/speakers.html
Contact: Director of National Accounts, Pierre Juillet
Telephone: 514.989.9111 X:211; Fax: 514-989-8773
Email: jessicaa@virtusinternational.com
Website: http://virtusinternational.com/pharma/speakers.html

3rd December 2006 - 5th December 2006 at the Maritim Pro Arte Hotel in Berlin, Germany [1082]
7th European Electronic Document Management Conference
The need and opportunity for managing records and regulatory submissions electronically, has never been so great in the pharmaceutical industry. This poses great challenges for business process, for industry standards and for related technologies so as to ensure quality and compliance over the full lifecycle of information management. Whether your organisation is entering electronic information management for the first time, optimising established processes and systems or pushing the boundaries of document and content management, it is vital for decision making within business to be based on up-to-date information concerning industry and technological standards, and on current Regulatory Agency expectations and the industry's response.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11153/Final_06114_25oct.pdf

4th December 2006 - 6th December 2006 at the Renaissance Scottsdale in Scottsdale, AZ, USA [866]
Advanced Topics in Clinical Research/Drug Development
This course reviews the identification and development of new therapeutic agents and the management of clinical development programs through interactive lecture and hands-on workshop training methods. Topics addressed include industry challenges, clinical operations, key documents, and quality concepts. The content for this course focuses on drugs and biologics development. Key Topics •Industry challenges: product identification and development, multinational studies. •Clinical operations: clinical process overview, project and resource management, ethics/hipaa. •Key documents: protocol development, crfs/data collection devices, study reports, nda/ctd preparation. •Quality concepts: study management and auditing.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9332/06422.pdf

4th December 2006 - 5th December 2006 at the Maritim Pro Arte Hotel in Berlin, Germany [869]
7th European Electronic Document Management Conference
The need and opportunity for managing records and regulatory submissions electronically, has never been so great in the pharmaceutical industry. This poses great challenges for business process, for industry standards and for related technologies so as to ensure quality and compliance over the full lifecycle of information management. Whether your organisation is entering electronic information management for the first time, optimising established processes and systems or pushing the boundaries of document and content management, it is vital for decision making within business to be based on up-to-date information concerning industry and technological standards, and on current Regulatory Agency expectations and the industry's response.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11153/06114.pdf

4th December 2006 - 5th December 2006 at the University of California Washington Center 1608 Rhode Island Ave. NW in Washington, DC, US [1058]
The Lewis B. Sheiner Memorial Symposium
The University of California, School of Pharmacy, Department of Biopharmaceutical Sciences, and the Center for Drug Development Science are pleased to announce the Lewis B. Sheiner Memorial Symposium, celebrating the seminal contributions in pharmacometrics innovated by the late Professor Sheiner. Former fellows, colleagues and friends of Lewis will gather to present latest developments that reflect his key scientific contributions, including therapeutic optimization and PK prediction in individual patients, individual and population PK/PD modeling and estimation, quantitative drug development science (modeling & simulation), and epistemology in drug development and drug regulation (causal evidence of effectiveness). A theme for discussion and debate throughout the conference will culminate in recommendations for a Model Curriculum in Pharmacometrics. A special session will be held on Sunday, December 3 for former Sheiner research fellows, students and visiting scientists featuring presentations and remembrances by these former members of Dr. Sheiner’s research team. The Memorial Symposium will be the forerunner of the Lewis B. Sheiner Lectureship in Pharmacometrics.
Contact: Bill Karpowicz
Telephone: ; Fax:
Email: info@sheinersymposium.org
Website: http://www.sheinersymposium.org/

4th December 2006 - 5th December 2006 at the Maritim Pro Arte Hotel in Berlin, Germany [870]
1st Annual Cardiac Safety Conference
Recent developments in the regulatory approach to drug safety in clinical drug development have triggered significant changes in the requirements for new drug applications and criteria for marketing approval. The new requirements, have now been adopted by the ICH organisation (topic E14) for global implementation and are mainly concerned with repolarisation-based (QT prolongation) Cardiac Risk Assessment (CRA). At the centre of these recent initiatives is the need for a well designed, well executed Through QT (TQT) Study with relevant statistical interpretation to ensure the cardiovascular safety of drugs in development. In addition, recent concerns involving certain COX-2 specific NSAID have highlighted the need for broader cardiac safety surveillance and Cardiac Risk Management (CRM) programmes, extending well beyond regulatory approval into the marketing stage. These concerns have now triggered further regulatory reviews of the drug development process and are expected to introduce further changes to the drug approval process and the post marketing commitments of drug manufacturers. This programme will review and address the above cardiac safety topics and will bring industry, academic and regulatory experts and representatives together with the aim of exchange of ideas and sharing information with the audience.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11247/06116.pdf

4th December 2006 - 5th December 2006 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [867]
Leveraging Knowledge Management Processes and Available Legal Protections for Secure Capture, Storage and Distribution
Knowledge Management (KM) is an integrated approach to identifying, managing, and sharing a company’s knowledge-based intellectual assets. As an industry sector dependent on innovation, embedding best practice in KM is key to ensuring continued success. While technology is an important enabler, addressing a knowledge culture and process is currently the greatest challenge. How far should we go? Should we seek to control and direct what people have come to know, what they have delivered as output and then enable it to be securely distributed? KM enables more efficient and effective team-based communication, cooperation and collaboration. The value of intellectual assets is a function of their ability to be shared – but to the right people at the right time; managing their security while providing appropriate distribution is a major challenge and needs clear management structures to ensure that there is responsibility for managing these assets. As companies increasingly seek to globalize their business models, the challenges we face are multiplied; language, time zone, and cultural differences are just some examples. Current and emerging knowledge management systems coupled with a clear legal strategy, business process model and management focus can substantially minimize these challenges.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11204/06031.pdf

4th December 2006 - 5th December 2006 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [915]
Electronic Patient Reported Outcomes (ePRO) Update: The Quest to Move from Paper to Plastic
Patient reported outcomes continue to be of increasing importance in assessing efficacy of new pharmaceutical products. Translating these measurements to the electronic world has brought evolving challenges. This unique conference will address an update to key elements in the adoption of electronic patient reported outcomes (ePRO) for use in the pharmaceutical industry. KEY TOPICS •Technology Aspects of the FDA PRO Guidance •From Paper to Electronic Diaries •Best Practices for Investigative Sites and Site SOPs •Selecting an Appropriate ePRO Technology.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11404/06025.pdf

4th December 2006 - 5th December 2006 at the Venue: The Rembrandt Hotel in London, UK [998]
THE CLINICAL TRIAL & GCP DIRECTIVES - An Interactive Workshop
The Clinical Trial Directive and the New GMP Directive are having major implications on how clinical trials are being managed in the EU. There are also several additional CT/GCP Directive guidelines which are due to be released to complete the Directives' requirements. EU countries have now transposed the main requirements of the CT Directive into national legislation, but in many countries Further Degrees, guidelines and other documents are being issued to complete the implementation. This transition period (until all the national requirements are fully implemented) has proven a challenge for many organisations seeking to carry out clinical trials in the EU. The Timing of the workshop is ideal ~ in that it provides an excellent opportunity to share experiences and discuss the current issues.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=533

5th December 2006 - 7th December 2006 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [871]
The Quest to Enable the Electronic Clinical Trial: Finding Clarity in a Confusing World
The clinical development life cycle has become increasingly complex and challenging scientifically while remaining inefficient and costly. The financial commitment needed to bring drug products to market continues to soar. It is crucial to develop technology solutions that work together and increase the speed and quality of the clinical trial process so that better answers about the safety and efficacy of investigational and marketed products are available to sponsors, agencies, investigators and the public more rapidly. With electronic healthcare just around the corner, industry faces increasing pressure to adopt enabling technology to optimize and accelerate drug development. But which technology, which tools, what initiatives are the most important ones to keep on your radar screen? If you are struggling with these questions, this conference is for you! •What technology and standards development initiatives are most critical to the biopharmaceutical industry and why? •How can you leverage some of the work underway in government agencies and standards-setting organizations and when? Which will have the most impact on our industry? •What information do you need to set priorities now, plan for future developments, and ensure quality and compliance? The information presented at this conference will help your organization compete….
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11116/06029.pdf

5th December 2006 - 6th December 2006 at the Venue: De Vere Cavendish in London, UK [999]
LABORATORY EQUIPMENT QUALIFICATION & COMPUTERISED ANALYTICAL SYSTEMS VALIDATION - Risk Based Approach "
The demonstrable validity of analytical methods and systems used to generate data either in support of Marketing Authorisations or for release of product onto the market, is seen by Regulatory Authorities as a key area for compliance. Proper procedures and practices for installation, qualification and calibration of analytical instrumentation is vital for the establishment of an operational baseline to support on-going performance monitoring to ensure demonstrable compliance. In addition, the software components associated with the instrument and system must be shown to be fit for their intended purpose. The objective of this seminar is to provide delegates with an appreciation of the regulatory requirements for qualification of analytical equipment and computerised analytical systems. Practical advice on risk assessment strategies and approaches to calibration, validation and routine monitoring of instrumentation and systems will be given. Both prospective and retrospective requirements will be covered and the interactive workshops will allow key areas of delegate interest to be addressed.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=415

6th December 2006 - 7th December 2006 at the Rosen Shingle Creek Report in Orlando, Florida, [968]
Biopharmaceutical Manufacturing & Development Summit
The Forum to Address the Industry’s Fastest Changing and Most Critical Topics by Bringing Together Expert Faculty and Interdisciplinary Teams Choose from 3 cutting-edge tracks IBC’s 3rd Disposables for Biopharmaceutical Production A Case Study Forum on the Validation, Design, Planning, and Implementation of Disposable Bioprocess Systems • Customer and supplier responsibilities for extractables and leachables • Implementation of single-use technologies from clinical to commercial scale manufacturing • Process models to minimize upfront investment of disposable technologies IBC’s Inaugural Challenges in Raw Materials Sourcing and Safety Speeding Process Development and Increasing Manufacturing Efficiency • Benchmark your risk assessment and management • Control change and ensure consistency • Learn supplier audit techniques IBC’s International Flexible Operations and Capacity Planning Maximizing Throughput and Efficiency in Multi-Product and Existing Biopharmaceutical Production Facilities • Wyeth’s 5000-fold increase in protein per batch • Genentech’s doubling of purification capacity in transferable process • Assess the buy, build or retrofit decision • Amgen’s yield improvements through PAT
Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.IBCLifeSciences.com/BMD

6th December 2006 - 7th December 2006 at the Ritz-Carlton in Berlin, Germany [1059]
Pharma Packaging & Labelling 2006
Conference designed to assess the various technological and regulatory issues around the pharmeceutical packaging industry. Topics include: - Complying with recent braille directives - Current anti-countfeiting strategies and technologies - Efficiently coordinating international labelling requirements - Finding out latest innovative technologies - Developing pharmeceutical packaging to enhance patient complience
Contact: Chris Howard Marketing Executive SPG Media
Telephone: ; Fax:
Email: chrishoward@spgmedia.com
Website: http://www.pharmapackaging-events.com/

6th December 2006 - 7th December 2006 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [1083]
The Quest to Enable the Electronic Clinical Trial: Finding Clarity in a Confusing World
The clinical development life cycle has become increasingly complex and challenging scientifically while remaining inefficient and costly. The financial commitment needed to bring drug products to market continues to soar. It is crucial to develop technology solutions that work together and increase the speed and quality of the clinical trial process so that better answers about the safety and efficacy of investigational and marketed products are available to sponsors, agencies, investigators and the public more rapidly. With electronic healthcare just around the corner, industry faces increasing pressure to adopt enabling technology to optimize and accelerate drug development. But which technology, which tools, what initiatives are the most important ones to keep on your radar screen? If you are struggling with these questions, this conference is for you!
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/11116/06029.pdf

6th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1000]
BASIC INTRODUCTION TO INTELLECTUAL PROPERTY - For Administrators, Secretarial and Support Staff
This course has been designed for administrators, secretaries and other support staff who are employed to maintain the work of an in-house Intellectual Property department or private practice firm. The comprehensive programme will provide an invaluable overview of the key aspects of intellectual property including the basics of what can be protected, what procedures are involved to achieve protection, what constitutes infringement of a patent and how patents may be enforced.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=188

6th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1001]
DRUG DEVELOPMENT - For Pharmaceutical Administrators & Support Staff
The course will provide a step by step description of the main areas of drug development and will discuss the roles and responsibilities of key staff involved as well as explaining the terminology. It will enable the participants to understand their contribution to the team and help them become more effective, professional and motivated in their daily work.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=117

6th December 2006 at the Hotel to be Announced in London, UK [1002]
INJECTABLE AESTHETICS - Skin Rejuvenation
In this workshop you will learn the advanced techniques in total lip contouring, facial contouring, asymmetric balancing, non surgical brow lift, filler techniques to give a youthful face and more. This will include a special segment on skin-rejuvenation with the latest intradermal techniques with Hyaluronic Acid THIS COURSE IS ALSO BEING HELD ON 29th NOVEMBER.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=528

7th December 2006 - 11th December 2006 at the Crowne Plaza, Hotel Park View Wuzhou, NO. 8 North Si Huan Zhong Road, Beijing, 100101 CHINA in Beijing, China [810]
1st International China Biopharmaceutical Symposium (ICBPS)
The Chinese Pharmaceutical Association (CPA), the China Biochemical Pharmaceutical Industry Association (CBPIA) and Battelle Memorial Institute invite the international community to participate in their first joint symposium in China in the very exciting area of biopharmaceuticals and the market. With the increasing concern in emerging infectious diseases, bioterrorism events and natural disasters, is there enough access to needed active pharmaceutical ingredients (APIs)? What can China do to sell its products in all markets and what can other countries do to sell their products in China?  How do Western drug and biotech firms get reliable APIs from China and protect their patents and intellectual property (IP)?  How do Western drug and biotech firms work with Chinese firms to introduce and market their products in China?
Contact: Richard M. Price
Telephone: 410 638-9480; Fax: 410 638-9481
Email: info@icbps.org
Website: http://www.icbps.org/

7th December 2006 at the Hesperia Hotel in London, UK [1113]
Material functionality and fitness for purpose in sold dosage forms
In the drive to make more reliable and efficient processes and effective products, industry is increasingly realising the importance that controlling the properties of the input materials, including both API and excipients, has in achieving these objectives. This meeting explores some of these important properties and the philosophy of the controls required.
Contact: Susan Hughes
Telephone: 020 7572 2640; Fax: 020 7572 2506
Email: science@rpsgb.org
Website: http://www.rpsgb.org/worldofpharmacy/events/

7th December 2006 - 8th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1003]
ADVANCED PCT FORMALITIES COURSE
The seminar will give a practical, in-depth understanding of the inner workings and finer details of the PCT mechanism. There will be room for detailed discussion of very specific items of the PCT procedure, both international phase and entry into the national/regional phase. Participants wil be given the opportunity to raise specific problems, and practical solutions will be put forward and discussed.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44(0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=320

7th December 2006 - 8th December 2006 at the Venue: The Harrington Hall Hotel in London, UK [1004]
THE PRACTICE OF ORAL PROCEEDINGS AT THE EPO - A practical, interactive and intensive course
Oral proceedings can occur during any stage of a European application. Each year, oral proceedings are appointed in about half of all opposition cases as well as over two-thirds of the appeal cases.This is in addition to several hundred in examination proceedings.Therefore at some point a European patent attorney will almost certainly have to appear at oral proceedings, either to defend a client's valuable invention or patent, or in an attempt to have patents held by the client's competitors revoked or limited in scope. A Patent Attorney's first experience of oral proceedings at the European Patent Office can be an intimidating experience, and it cannot be assumed that knowledge of their own national system will enable them to represent their clients to optimal effect. In order to defend a client's interests competently, it is vital to be properly prepared, and to know what to expect at this European level. This workshop will give participants an opportunity to increase their knowledge of current practice in the EPO and to develop confidence and skill in preparing for and appearing at oral proceedings at all levels.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=55

7th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1005]
US FDA QUALITY SYSTEMS REQUIREMENTS FOR MEDICAL DEVICES - FDA Inspections – Are You Prepared?
This one day seminar will address the US FDA Quality System regulation with emphasis on FDA's current focus. The US FDA requirements will be presented to compare and contrast with ISO13485 and ISO14971 Risk Management. Actual FDA Warning Letter examples will be used to illustrate key points. In addition, the FDA inspection process will be explained with advice on how to prepare your company to respond to 483s and Warning Letters.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=508

8th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1006]
US FDA CORRECTIVE AND PREVENTATIVE ACTION (CAPA) FOR MEDICAL DEVICES
More than 50% of FDA's 483 Observations and Warning Letters are Corrective and Preventative Action (CAPA) related. This one day seminar will address the requirements and expectations of CAPA to meet the US FDA medical device requirements.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=509

11th December 2006 at the Online in Online, USA [1130]
Bio-Pharma Meets Healthcare Information Technology @ HIMSS 2007
CDISC and IHE have organized the first concrete demonstration of interoperability between bio-pharma information systems and healthcare information technology. Building on an IHE integration profile known as Retrieve Form for Data-Capture (RFD), bio-pharmaceutical companies and electronic health record (EHR) vendors will demonstrate their work at the HIMSS 2007 Interoperability Showcase. This webinar foreshadows the Showcase, and explains the scenarios, the goals, and the current state of the development.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12590/06256.pdf

11th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1007]
VETERINARY GENERICS IN THE EU
Introduction 2004/28 came into force in October 2005, amending Directive 2001/82, and brought with it significant changes to the regulation of generic veterinary medicines in the European Union. This applies also to so-called 'branded generics' that are usually authorised by way of Article 13.1(a)ii (bibliographic dossiers) as well as to true generic products authorised according to Article 13. The changes have implications for both manufacturers of generic veterinary medicines and for research-based companies that seek to protect their products from competition. This seminar will examine the experience gained in implementing the new legislation to provide valuable advice to all in the animal health industry. The difficulties of authorisation of generic products in the Mutual Recognition and Decentralised Procedures will also be addressed.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=499

11th December 2006 - 12th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1008]
THE EU PHARMACEUTICAL DOSSIER - CTD Modules 2.3 and 3
The conference will provide a wide-ranging, up-to-date coverage of the pharmaceutical issues that underpin a successful marketing authorisation application. In a carefully-structured programme, delegates will learn about the key components of the EU licensing systems for substances for pharmaceutical use and for finished medicinal products. Delegates will learn about sources of official information and expert guidelines, and will find out how to prepare the 'Quality' parts of the CTD (in Modules 1.3, 2.3 and 3). Information will also be given on common deficiencies in the pharmaceutical dossier. It is anticipated that the course will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject areas. All the speakers have had many years' experience working in or for the UK regulatory authorities and also for various other bodies with multi-national regulatory activities. There will be ample opportunity for question and answer sessions throughout the two days of the course, further to enhance the delegates' understanding of pharmaceutical issues of individual concern. PLEASE NOTE: THIS MEETING WILL BE HELD AGAIN IN JUNE 2007 IN NICE, FRANCE. THE DATES WILL BE CONFIRMED AT A LATER DATE.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=549

11th December 2006 - 12th December 2006 at the Venue: The Cafe Royal in London, UK [1009]
PORTABLE INHALERS: ANNUAL CONFERENCE
Delivery via the pulmonary route is in a significant growth period with some exciting therapies in clinical trials. Supporting this is the development of significant delivery technologies and understanding of the factors that improve patient use and compliance. This conference will consider the latest understanding of the Asthma disease state and how this is being used to develop new therapies. It will also discuss the benefits of inhaled insulin and the potential of this area. An overview of the inhaler market, growth areas and the generic company approach to this market are imperatives for senior managers and strategic business planners. This conference will also feature recent inhaler selection guidelines, patient inhaler selection studies and discuss the significance of patient inspiratory flow profiles, all fundamental in effective product design. This meeting is complimentary to the Dry Powder Inhaler Conference (June 2006) and will provide the latest advances associated with pressurised metered dose inhalers. These advances have overcome both delivery and patient use issues associated with the first generation pMDIs. Significant technology advances will be showcased, these advances offer real alternative product development strategies and need to be considered in any product development plan.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=286

11th December 2006 - 13th December 2006 at the Venue: The Rembrandt Hotel in London, UK [1010]
THE PHARMA MINI-MBA - Cover the Core Curriculum of an MBA in just 3 days
This intensive three day course covers the core areas of an MBA and applies these skills to the pharmaceutical industry – using industry case studies and your own issues. This ‘Mini MBA’ is especially designed to build your management skills for the future and to enable you to more effective and efficient. This three day interactive workshop will work through live issues impacting on the Industry and on participants directly. Key benefits are individual learning, attitude and behaviour shift and diagnosis of current business and organisational issues.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=45

12th December 2006 at the EMEA in Canary Wharf, London, United Kingdom [872]
EudraVigilance: Medicinal Product Dictionary
The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9416/06524.pdf

13th December 2006 - 15th December 2006 at the EMEA in Canary Wharf, London, United Kingdom [873]
EudraVigilance: Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course. The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/9411/06525.pdf

13th December 2006 - 15th December 2006 at the Venue: Harrington Hall Hotel in London, UK [1012]
PHARMACOVIGLANCE - A Basic Training Course
This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe and the USA.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44(0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=546

2007

January 2007

4th January 2007 - 5th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1013]
EUROPEAN QUALIFYING EXAM PAPER D REVISION COURSE - Answering Legal Questions
THIS COURSE IS GIVEN BY Peter O'REILLY from the EPO. Paper D is one the hardest papers of the European Qualifying Examination, particularly Part II of the paper. This course will teach the participants a clear method for approaching both parts this paper. The main stress of the course will be the answering of Part II of the paper. At the end of the course the participants will have learnt a method of answering both parts of the paper. They will be able to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=321

5th January 2007 - 6th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1027]
EUROPEAN QUALIFYING EXAM PAPER D REVISION COURSE - Answering Legal Questions
THIS COURSE IS GIVEN BY Peter O'REILLY from the EPO. Paper D is one the hardest papers of the European Qualifying Examination, particularly Part II of the paper. This course will teach the participants a clear method for approaching both parts this paper. The main stress of the course will be the answering of Part II of the paper. At the end of the course the participants will have learnt a method of answering both parts of the paper. They will be able to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=321

14th January 2007 - 18th January 2007 at the Renaissance Washington, DC Hotel in Washington, DC, USA [1036]
6th Annual DIA Conference for Contemporary Pharmacovigilance and Risk Management Strategies
The field of medical product safety continues to grow in complexity, with both clinical trial safety and postmarketing pharmacovigilance becoming ever more critical in the development and marketed use of medical products. The inherent limitations of premarketing testing and ongoing focus on the risks associated with medical product use have fostered new thinking and methods for monitoring the evolving safety profiles of marketed products throughout their life cycle. Further, while the field of risk management has added a new dimension to product safety, as an evolving discipline it requires ongoing refinement in order to enhance its applicability and value to public health. This comprehensive four-day program will address the current complexities and controversies in pharmacovigilance and risk management through discussion of the latest safety-related regulatory initiatives, description of how to optimally utilize epidemiological, clinical pharmacological and other techniques, and presentation of “state of the art” risk management strategies using illustrative examples and case studies. For more information please visit http://www.diahome.org/product/12262/07002.pdf
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/

15th January 2007 - 17th January 2007 at the The Rembrandt Hotel in London, UK [1047]
PHARMACEUTICAL REGULATORY AFFAIRS IN ASIA - including INDIA
The aim of this meeting is to provide an understanding of the key areas of regulatory affairs in Asia including India, focusing on the practical aspects to assist regulatory activities in this region and will include the latest updates and opportunities for interactive discussion. Including China, Hong Kong, ASEAN, Brunei, Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Taiwan, Korea, Cambodia etc.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=557

17th January 2007 - 18th January 2007 at the The Rembrandt Hotel in London, UK [1029]
ISOLATORS - RISK MANAGEMENT, COMPLIANCE - ICQ (Integrated Commissioning Qualification)
With a Focus on New Technological Development & How Existing Technology May Be Effectively Applied, London . If you are concerned with either aseptic or containment isolators, at any stage from initial specification right through to production operation and maintenance, then this is the forum for you to learn more and to discuss your experience with others in the field. Integrated commissioning and validation is a relatively new concept which promises dramatic reductions in validation times, but does it work? Restricted access barrier systems are offering an alternative to isolators but what are they? Biological indicators are a perennial problem with isolators and gassing validation, what help is there? This conference brings together an international panel of specialists with practical working knowledge of the issues which challenges those working with isolator technology today.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=551

18th January 2007 - 19th January 2007 at the Hilton San Francisco Fisherman's Wharf in San Francisco, CA, USA [1085]
European Regulatory Affairs
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 1995. It reviews Centralized, Mutual Recognition, and national registration procedures in detail, and includes practical examples of product types particularly suited to each procedure.There will also be a discussion on the new medicines legislation, which is effective November 2005, and how it changes access to centralized procedure and alters regulatory data protection.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12446/07416%20January%20EuroReg.pdf

18th January 2007 - 19th January 2007 at the The Rembrandt Hotel in London, UK [1061]
EFFICIENT STABILITY TESTING
This conference will review the regulatory background to stability testing for both new and existing drug substances and products. The ICH guidelines will be covered from a practical point of view with guidance on interpretation and how to design the most efficient protocols to minimise resource requirements and to ensure high quality stability modules in regulatory submissions. As well as the design of stability protocols, all aspects of stability testing will be covered, including the development of robust, stability indicating analytical methods and the management of stability samples and storage facilities. Workshops are included to reinforce some of the topics.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=567

18th January 2007 - 20th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1014]
EUROPEAN QUALIFYING EXAM PAPER C REVISION COURSE - Drafting an Opposition
THIS COURSE IS GIVEN BY Peter O'REILLY from the EPO. Paper C is probably the hardest paper of the European Qualifying Examination. This course will teach the participants a clear method for approaching this paper. At the end of the course the participants will have learnt a method of answering the paper. They will be able to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=253

18th January 2007 - 19th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1015]
EUROPEAN QUALIFYING EXAM PAPER C REVISION COURSE - Drafting an Opposition
THIS COURSE IS GIVEN BY Peter O'REILLY from the EPO. Paper C is probably the hardest paper of the European Qualifying Examination. This course will teach the participants a clear method for approaching this paper. At the end of the course the participants will have learnt a method of answering the paper. They will be able to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=253

19th January 2007 - 20th January 2007 at the Venue: The Rembrandt Hotel in London, UK [1026]
EUROPEAN QUALIFYING EXAM PAPER C REVISION COURSE - Drafting an Opposition
THIS COURSE IS GIVEN BY Peter O'REILLY from the EPO. Paper C is probably the hardest paper of the European Qualifying Examination. This course will teach the participants a clear method for approaching this paper. At the end of the course the participants will have learnt a method of answering the paper. They will be able to go to the examination knowing exactly how they will use the time allowed and how they will set out their answer.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=253

21st January 2007 - 24th January 2007 at the University of Southern California in Irvine, CA, USA [1084]
Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase
This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA. Key Topics •Overview of FDA •Regulatory requirements for drug development and approval •Post-approval and marketing regulatory requirements and processes •Overview of the CTD format.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12244/07401%20January%20Reg%20Combo%20USC.pdf

21st January 2007 - 24th January 2007 at the University of Southern California in Irvine, CA, USA [1035]
Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase
This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA. Key Topics Overview of FDA Regulatory requirements for drug development and approval Post-approval and marketing regulatory requirements and processes Overview of the CTD format.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12244/07401%20January%20Reg%20Combo%20USC.pdf

22nd January 2007 at the The Rembrandt Hotel in London, UK [1016]
MULTI-TASKING & MANAGING MANAGERS IN THE PHARMACEUTICAL INDUSTRY
In the very challenging environment of the pharmaceutical industry, the role of administrators, support staff and secretaries has become increasingly demanding as they need to be working with multiple tasks (and sometimes their conflicting) projects, deadlines and assignments. They also need to manage managers who are frequently out of the office, and working with more than one manager. This highly stimulating and interactive course will enable participants to become more effective and enthusiastic and enhance their organisational skills which in turn will help them become more productive. They will also learn how to manage priorities and projects and how to keep things running smoothly when their Manager is away. Participants will gain practical skills that will enable them to be much more valuable and more effective than previously, thus enabling them to take on more responsibility and have greater job satisfaction.
Contact: Barbara McManus / Leigh White
Telephone: +44 (0) 1483 730071; Fax: +44 (0)1483 730008
Email: mailto:info@management-forum.co.uk,%20leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=540

24th January 2007 - 25th January 2007 at the Washington Marriott Hotel in Washington, DC, USA [1125]
Sharing Knowledge to Improve Clinical Drug Development and Regulatory Decisions: Data/models of Diseases, Drugs, Placebo, Baseline, and Dropouts
Clinical trial failure in late development (Phase 3) is a risk that companies cannot afford, particularly if the failure is predictable. The FDA Critical Path Opportunities List recognizes several joint development paths that could improve pharmaceutical productivity and reduce failure rates. These paths include: •Better understanding of prior information in making current drug development and approval decisions •Better understanding of disease through biomarkers •Application of modern bioinformatics to mine prior knowledge (e.g., NDAs) sources Oftentimes, useful prior clinical trial information that could improve drug development efficiency is lost within companies and at the FDA. This information could help us to better understand the biomarker relationship to primary disease endpoints, disease change over time, placebo effect, and drug effect on disease. These quantitative relationships can help employ biomarkers (e.g., biochemical, imaging, genomic) in dose finding, the creation of new surrogate markers, planning of effective clinical trials, and making better clinical development and regulatory decisions.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/product/12234/07005.pdf

24th January 2007 - 25th January 2007 at the The DeVere Cavendish Hotel in London, UK [1038]
EC MEDICAL DEVICE VIGILANCE SYSTEMS AND POST MARKETING SURVEILLANCE
While the pre-market approval process has been delegated by most of the Competent Authorities to the private sector, Competent Authorities have kept the responsibility for the surveillance of their market. Because of this situation, there is transfer of resource and energy to the monitoring of market including the Vigilance System within each Member State. The evaluation of incidents notified by the manufacturers and users represents a key source of information. Combined with sophisticated exchange of information between EU Member States, and also with other countries like USA, Japan, Canada or Australia, this provides a unique insight of the performance of devices in the post production phase. Full compliance with the vigilance requirements laid down in Article 10 of directive 93/42/EC is justified by the manufacturer’s legal obligations, risks associated to litigation and increasing scrutiny of Member States, but mainly by the ultimate objective of providing saf