Register today

Hear Dr. Stella Blackburn, Risk Management Development and Scientific Lead at the European Medicines Agency, address the new European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study code of conduct at the Post-Approval Summit in Basel, Switzerland.

Dr. Blackburn will discuss ENCePP, run by the European Medicines Agency, and its new initiatives intended to promote research quality. The recently introduced Code of Conduct for Independence and Transparency, and Checklist of Methodological Standards for ENCePP Study Protocols have been designed with an emphasis on non-interventional post-authorization studies. Core requirements that must be met to qualify a study as an “ENCePP study” and plans for the e-Registry of Post-Authorisation Studies will be described.

The Summit focuses on practical issues and considerations with designing post-approval studies in Europe, including:

• Designing effective studies
• Epidemiology and statistical considerations
• Practical operational considerations
• Managing post-approval specific regulatory hurdles
• Evaluation criteria and implications for meeting regulatory requirements and publications

The agenda also includes real-world case studies and an interactive workshop. View the full agenda or register online at www.basel.postapproval.org.

Register Today!
Register by 30 July 2010 and save €150! Registration before 30 July is €400 and after 30 July is €550. Contact us to learn more about our group discounts. Your registration includes breakfast, lunch, and admittance to the evening networking reception.

We look forward to seeing you in September!

Best Regards,

The Committee for the Post-Approval Summit
+1 617 621 6426
[email protected]
201 Broadway, Box 12, Cambridge, MA 02139
United States