European Regulatory Affairs
|Event Date/Time: Sep 25, 2008||End Date/Time: Sep 26, 2008|
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.
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.