American Conference
Institute (ACI) will be holding its European Pharmaceutical Regulatory Law Boot
Camp from January 25-26, 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 (the
EMEA);
• Understand the
role of the EMEA 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 in Europe;
• Learn how the
EU's approval of biosimilars may influence the development of an abbreviated
pathway for follow-on biologics in the U.S.;
• Explore new FDA/
EMEA 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 Qualifi ed Persons
(QPs) in these processes.

In particular,
ACI's faculty will offer presentations on the following topics:

• The EMEA:  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 EMEA;
• 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;
• Drug promotion
and the current status of DTC advertising in the EU;
• EMEA/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 complete brochure
for this conference, including an agenda, list of speakers, and registration
form can be downloaded here.

The registration
fee for this conference is $2,195. 
Those registering by January 8, 2010 will receive a $200 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.