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

Event Website : THE US DRUG APPROVAL PROCESS

Location:	The Cavendish Hotel, London
Contact:	Leigh White leigh@management-forum.co.uk 44 1483 730071
Organization:	Management Forum Ltd
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