THE US DRUG APPROVAL
PROCESS

Conference Date: 09-10 Feb 2010
Conference Ref: A2-1110
Fee: £1090 + VAT
Venue: The Cavendish Hotel, London

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

Click here to book your place.