The US Drug Approval Process
9th February - 10th February 2010 | UK
Category: R&D
Address: The Cavendish Hotel, 81 Jermyn Street, London, SW1, UK
Organiser: Management Forum
Website: CLICK HERE to open.
**XMAS OFFER** - Book this event before 25th December and Receive 200 GBP off the Booking Fee.
General Introduction and important information on FDA Procedures, requirements for marketing authorizations and recent developments affecting the drug approval process
TOPICS COVERED AT THIS TWO DAY MEETING:
Structure and functions of the FDA
- Historical background
- General regulatory requirement
- Regulation of preclinical and clinical research
- New drug application process
- Biologics
- Special issues
- Recent legislation, including Food and Drug Administration Amendments Act of 2007 and proposed legislation to govern follow-on biologics
With:
Richard Kingham - Senior Partner, assigned to the Washington and London offices of Covington & Burling LLP
All Management Forum events count towards 5.5 CPD Points per day. For more information on this event, please contact leigh@management-forum.co.uk or for a brochure, please visit:
http://www.management-forum.co.uk/pharmaceutical/eventid/1233
