European Regulatory Affairs

Venue: Hyatt Regency Boston

Location: Boston, Massachusetts, United States

Event Date/Time: Aug 15, 2011 End Date/Time: Aug 16, 2011
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Learn the practical side of the approval system in the European Union and how to apply the centralized mutual recognition and national registration procedures to a variety of products.


· 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 pertinient to commercial, business, and licensing arrangements

· Trademarks and patents

· Medical devices

· Clinical trial directive

· Legal status and switching

Learning Objectives:

At the conclusion of this course, participants should be able to:

· Apply the importance of the Single Market to your studies

· Use current registration filing application procedures in the EU for various product types

· Plan for common issues and integrate solutions such as trademark and patents into your studies to ensure timelines are met

· Plan for and meet new medicines legislation for your products

· Develop protocols that ensure effective clinical trials

Target Audience:

· Regulatory affairs professionals

· Project managers

· Clinical research professionals

Event Code: