home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops  
 

European Regulatory Affairs

 
  March 31, 2006  
     
 
Drug Information Association, Renaissance Hotel
Sep 4 2006


The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines
Legislation.

The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail.
Detailed review will be offered on the changed Centralized and Mutual Recognition Procedures and New Decentralized Procedure with discussion of practical examples of product types suitable for each procedure. The workshop will provide strategic advice on how to file applications for the marketing authorizations in the European Union for staff involved in International Regulatory Affairs.

Key Topics
European Union.
Centralized Procedures.
Decentralized Procedure.
Mutual Recognition Procedure.
National Procedure.
Key Issues to Consider for Business Opportunities.
Regulatory Strategy.
Legal Status of Products and Switching from Rx to OTC.
Medical Devices Legislation.
Clinical Trial Directive.

 
 
Organized by: Drug Information Association
Invited Speakers: Brenton E. James
 
Deadline for Abstracts: -
 
Registration: http://www.diahome.org/product/9225/06503.pdf
E-mail: dia@diahome.org
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.