European Regulatory Affairs
|Event Date/Time: Nov 26, 2007||End Date/Time: Nov 28, 2007|
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.
•De Centralized Procedure
•Mutual Recognition Procedure
•Key Issues to Consider for Business Opportunities
•Legal Status of Products and Switching from Rx to OTC
•Medical Devices Legislation
•Clinical Trial Directive.