European Regulatory Affairs Course

Date(s) And Time(s):
Mar 7 2011 12:45PM - Mar 8 2011 4:00PM

Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509


Best-Value Course on Registration Procedures in the European Union

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:

Contact Information:

For detailed program information including faculty and topics, please contact:
Susan Mazak
Tel. +1-215-442-6183