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

European Regulatory Affairs

 
  May 15, 2010  
     
 
SAS Radisson Hotel Boulogne , Boulogne-Billancourt (Paris)
Nov 18 2010 1:00PM - Nov 19 2010 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.

Key Topics:

  • European Union
  • Centralised Procedure
  • Decentralised 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
Learning Objectives:

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

  • Explain the registration procedures for filing applications for medicinal products in the European Union and recognize what route is available for each product type (NCE, biotechnology, OTC and generic)
  • Describe the concepts of global marketing authorisation and regulatory data protection
  • Discuss the key issues that impact the choice of the registration procedure including trademarks and patents 
  • Describe the legislation effecting Medical Devices and procedures for obtaining Clinical Trial and Ethics Committee approval in Europe
Target Audience:

Professionals in regulatory affairs, clinical research, project management, toxicology, product development and data management.

Event Code:
10540

 
 
Organized by: DIA Europe
Invited Speakers: call contact
 
Deadline for Abstracts: Call contact
 
Registration: Contact Information:
DIA Europe ELISABETHENANLAGE 25, POSTFACH

4002 BASEL

SWITZERLAND

TEL.: +41 61 225 51 51FAX:  +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.