FDA Legal Aspects of Clinical Research

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Successful FDA Meetings. West Coast Drug Development Forum: Challenges
in the Development of Therapeutic Products. DIA, Half-Day Tutorial,
October 25-27, 2004, San Francisco.

Study Contracts: Do You Understand What You Just Signed?. North Texas Chapter,
ACRP, Annual Education Symposium, October 16, 2004, Dallas, Texas.

How to Negotiate Other Important Contract Terms. 14th International Contracting &
Negotiating Clinical Trials. Strategic Research Institute. September 27-28, 2004, La Jolla,
CA.

FDA Enforcement -- What You Need To Know To Avoid -- Or Respond. DIA Annual
Meeting, Half-Day Tutorial, June 2004, Washington, D.C.

State Regulation of Clinical Research. Society of Quality Assurance Annual
Meeting, Clinical Track, Washington, D.C., October 2003.

What Every Clinical Director Must Know About FDA Regulatory Compliance.
DIA Annual Meeting, Half-Day Tutorial, June 2003, San Antonio.

FDA’s “Combination” Product Policy. Scripps Clinic-BIO 5th Annual Drug
Development Conference, February 2003, La Jolla, CA.

Financial Disclosure in Clinical Research. ACRP, San Diego Chapter, January
2003, San Diego.

“Specific Payments of Other Sorts:” Sifting Through the SPOOS. Barnett-Parexel
Conference on Financial Disclosure, Half-day Workshop, November 2002,
Philadelphia.

Financial Disclosure Issues in Clinical Research. FDA Regulatory Law Breakfast
Briefing, “What You Need to Know Before Beginning Your Clinical Trial,” October
2002, San Diego.

Indemnification in Clinical Research. DIA Good Clinical Practice Conference,
February 2001, Tucson, AZ.

The Institutional Review Board (IRB) and the Clinical Investigator -- Legal/Regulatory
Requirements and Perspectives. FDA/Orange County Regulatory Affairs (OCRA)
Discussion Group Annual Educational Conference, July 2000. Irvine, CA.

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