With the increasing level of attention being placed on the FDA's regulation of pharmaceuticals as well as the globalization of clinical trials, this year's Clinical Research Administration Distinguished Speaker Series will include officials from the government and the private sector who will discuss the regulatory and compliance aspects of clinical research.
The fifth annual version of the series will again take place at St. Joseph's Hospital Education Center Auditorium, 4936 W. Clark Rd., in Superior Twp.
"This year's selection of speakers includes some of the most respected individuals in their fields," said Stephen Sonstein, director of Eastern Michigan University's Clinical Research Administration program.
This year's speakers and dates are as follows:
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LePay |
Cynthia L. Kirk, of CLK Regulatory Solutions, presents "Innovations in Medicines Development: A Regulatory Perspective," Thursday, Feb. 14, 7:30 p.m. Kirk is the past president of the Drug Information Association.
David LePay, director, Good Clinical Practices Programs, Office of the Commissioner, U.S. Food and Drug Administration, presents "Quality and Compliance in FDA-Regulated Clinical Research," Wednesday, March 19, 7:30 p.m. LePay is known as the FDA's "Mr. GPC."
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Houlihan |
Earl W. Houlihan, vice president, global regulatory affairs and quality assurance, Medidata Worldwide Solutions, presents "Globalization of the Clinical Research Enterprise," Thursday, April 10, 7:30 p.m. Houlihan is an expert on global clinical trials and adviser on the Chinese Regulatory Authority.
This series is free and open to University students, faculty, staff and the general public. The Association of Clinical Research Professionals (ACRP) will award continuing education units (CEUs) for its members who attend. There will be a coffee and cookies reception following each talk where attendees can meet and interact with the speakers.
For more information, call Sonstein at 487-1238 or e-mail him at Stephen.sonstein@emich.edu
