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

Training Course on European Regulatory Affairs

  February 19, 2011  
Ramada Plaza Basel, Basel, Switzerland
May 30 2011 1:00PM - May 31 2011 4:00PM

This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory
affairs, clinical research, project management and other disciplines involved in the development of medicinal products.

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. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005.

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 Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure.

Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described.

Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive.

The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs.

Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.


 Event Code:

Organized by: DIA Europe
Invited Speakers: See website for speaker information
Deadline for Abstracts: Call contact
DIA Europe 

4002 BASEL 



TEL.: +41 61 225 51 51
FAX:  +41 61 225 51 52

E-mail: diaeurope@diaeurope.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.