THE US DRUG APPROVALPROCESS 2011

General Introduction and important information on FDA Procedures, requirements for marketing authorizations and recent developments affecting the drug approval process

OBJECTIVE
This seminar, by a US lawyer with over 35 years of experience dealing with pharmaceutical regulation in the United States and Europe, will provide a general introduction to all aspects of the US drug approval process. It will also cover the organisation and structure of the Food and Drug Administration, recent amendments to the FDA s procedures designed to expedite the testing and approval of new medicines and other topics of current interest and discuss the new report by the Institute of Medicine of the National Academy of Sciences of the FDA Drug Approval Process.

WHO SHOULD ATTEND
This meeting will be especially helpful for persons responsible for preparing US registration documents (INDs, NDAs, biologics licence applications, etc), regulatory affairs personnel and those responsible for advising companies on strategies for developing new drugs for the US market. The seminar will emphasise issues of interest to innovative manufacturers, but will also deal with issues relating to generic drugs and over-the-counter drugs.

TOPICS TO BE 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 biosimilars legislation

With:
Richard Kingham - Senior Partner, Covington & Burling LLP, Washington, DC