Product/Service
2nd Joint DIA/EMA/CMD(h) Variations Conference
•Event Brochure: 2nd Joint DIA/EMA/CMD(h) Variations Conference
Date(s) And Time(s):
Nov 23 2010 8:00AM - Nov 23 2010 5:30PM
Location:
Radisson Edwardian New Providence Wharf London
5 Fairmont Avenue
Canary Wharf
London
E14 9PQ
United Kingdom
Interest Area(s):
Regulatory Affairs
Overview:
Since 1 January 2010 the new Variation Regulation for Human and Veterinary Marketing Authorisations granted through Mutual Recognition (MR) and Decentralised Procedure (DCP) as well as through Centralised Procedure (CP), apply.
In this conference different stakeholders present their experience with the new system in the first ten months after implementation. Speakers from the European Commission, the EMA, the CMDh, National Competent Authorities and pharmaceutical industry will give their opinion on successful and unsuccessful aspects of the revised Variation Regulation as well as the procedural and classification guidelines.
The nationally granted Marketing Authorisations are still outside of the scope of the Variation Regulation. The conference will give an update of the current status of the development of the 2nd Comitology procedure and the planned implementation timetable of the Variation Regulation for purely national licences.
Click Here To Download:•Event Brochure: 2nd Joint DIA/EMA/CMD(h) Variations Conference
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