Expert to Speak on
Drug Development Process Oct. 12
Windsor, N.J. - Michael Falkow, director and principal consultant
for Parexel International, a leading global bio/pharmaceutical
services organization, will examine the intricate clinical
drug trial process in his talk, "Drug Development
and Approval in the U.S. - Not Just for Biochemists,"
on Wednesday, Oct. 12 at noon at Mercer County Community College.
This free lecture will be presented in the Communication Building,
CM 107, on the West
Windsor campus, 1200 Old Trenton Road. The talk is part
of Mercer's Distinguished Lecture Series for the fall 2011
A former Food and Drug Administration (FDA) investigator and
drug specialist, Falkow will draw upon his vast expertise
to explain the legislative history of the agency and the process
it has established for pharmaceutical development and manufacturing,
as well as approval and control.
Falkow's areas of specialization include pharmaceuticals,
biotechnology, in-vitro diagnostics and medical devices, with
a specific focus on regulatory and quality compliance, quality
auditing, quality assurance, and analytical research and development.
He is approved by the FDA as a Good Manufacturing Practice
(GMP) certifying authority.
his previous positions, Falkow served as head of Regulatory Compliance
and Quality for the American Red Cross, head of Global Chemistry,
Manufacturing and Controls with Aventis Pharmaceuticals, head of
Strategic Quality Services at Johnson & Johnson-Merck, and head
of Quality Management World-Wide at Whitehall-Robins (now Pfizer).
He is a member of numerous professional organizations, including
the American Society for Quality, the International Society for
Pharmaceutical Engineering, and the Regulatory Affairs Professionals
For more details about MCCC's Distinguished Lecture Series, click
or call 609-570-3324.
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