American Conference Institute (ACI) will be holding its European Pharmaceutical Regulatory Law Boot Camp from November 15-16, 2010 in New York. The conference will allow attendees to:
• Master the essentials of the different modes of the European drug approval process, including Centralized Procedure through the European Medicines Agency (EMA);
• Understand the role of the EMA within the EU and its juxtaposition with other European pharmaceutical regulatory bodies, including MHRA, BfArM/PEI, and affsapps;
• Comprehend the EU Patent/Regulatory interface and the complexities surrounding data exclusivities and generic approvals;
• Learn how the EU’s approval of biosimilars may influence the development of abbreviated pathway for follow-on biologics in the U.S.;
• Explore new FDA/EMA harmonization initiatives;
• Examine the scope of the EU Clinical Trials Directive and its ties to the EU Data Protection and Good Clinical Practice Directives;
• Appreciate the regulatory significance of the EC's DG Competition's Pharmaceutical Sector Inquiry vis-à-vis marketing authorizations, patents, and pricing;
• Recognize the role of comparative effectiveness, and comparator and therapeutic evaluation studies, in drug approval and development in Europe;
• Decipher the relationship between the regulation of drug promotion and the status of DTC Advertising in the EU;
• See the importance of cGMPs to the post-approval regulatory process in Europe; and
• Navigate EU adverse events and pharmacovigilance protocols, including Risk Management Plans (RMPs), use of the EudraVigilance database and the role of Qualified Persons (QPs) in these processes.
In particular, ACI's faculty will offer presentations on the following topics:
• The EMA: Exploring its unique role in the EU and its significance to the global pharmaceutical industry;
• A look at other European pharmaceutical regulatory bodies and their interplay with EMA;
• The nature of the drug approval process in Europe via Centralized Procedure and other methods;
• Understanding EU clinical trials and procedures;
• Demystifying the patent/regulatory interface in the EU: Generic approvals, exclusivities, and more;
• Biosimilars: A study of follow-on biologics in the EU;
• cGMPs in the EU;
• Analyzing the regulatory significance of the findings of the EC's DG Competition's Pharmaceutical Sector Inquiry;
• The current status of DTC advertising in the EU;
• EMA/FDA harmonization efforts: Assessing their impact on the global pharmaceutical industry;
• Adverse events monitoring and pharmacovigilance protocols in the EU;
• Comparative effectiveness and therapeutic evaluation studies: Understanding their scope and magnitude for EU drug development and commercialization; and
• Drug recalls in the EU: Everything you need to know.
A post-conference workshop on "Navigating European Medical Device Regulations: Understanding the Differences between Various Member States’ Regulations and Contemplating the Prospect of Harmonization," will be offered November 17, 2010. In this workshop, ACI faculty will discuss all aspects of EU medical device regulation, which though trending towards becoming similar to the harmonized EU regulation of medicinal products, is still governed by individual member states.
The agenda for the European Pharmaceutical Regulatory Law Boot Camp can be found here. A complete brochure for this conference, including an agenda, description of the sessions, list of speakers, and registration form can be downloaded here.
The registration fee for this conference is $2,295 (conference alone) or $2,895 (conference and workshop). Those registering by October 15, 2010 will receive a $200 discount off the registration fee, and those registering by September 17, 2010 will receive a $300 discount off the registration fee. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media partner of ACI's European Pharmaceutical Regulatory Law Boot Camp.
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