European Regulatory Affairs
Venue: Renaissance Paris Hotel La Défense
Location: Paris la Défence Cédex, France
Event Date/Time: Nov 17, 2008 | End Date/Time: Nov 18, 2008 |
Description
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.
The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in International Regulatory Affairs.
- European Union
- Centralised Procedures
- 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.