Pre-Conference
Day One
Day Two
Day Three
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Agenda: Pre-Conference Workshop Agenda
Tuesday, Aug. 22, 2006
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12:00 p.m. |
Registration (Memorial Hall Transept)
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1:00 p.m.
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Preconference Workshop I: Strategies to Prepare for Meetings with the FDA
Igor Cerny, Pharm.D.
Director, CDER Advisors and Consultants Staff
Office of Executive Programs
FDA
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Kim Colangelo
Associate Director for Regulatory Affairs, Office of New Drugs
Center for Drug Evaluation and Research, FDA
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Margaret Hurley, MD
President and CEO
Hurley Consulting Associates Ltd.
Chatham, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Robert M. Kirsch, RAC
Vice President - Regulatory Affairs, TolerRx, Inc.
TolerRx, Inc.
Cambridge, MA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Susan M. Mondabaugh, Ph.D.
Vice President - Regulatory Affairs
Hurley Consulting Associates Ltd.
Chatham, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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- OR -
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1:00 p.m.
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Preconference Workshop II:
Powerful Business Writing: Capture, Persuade and Motivate
Linda Rivero
Founder and President, Voice of Persuasion
Former Adjunct Professor of Language
State University of New York and Iona College
Alexandria, VA
Nancy Singer, Esq.
President, Compliance-Alliance, LLC
Former Special Counsel, AdvaMed
Founder, AdvaMed Medical Technology Learning Institute
Arlington, VA
Permission to post not granted
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5:00 p.m. |
Adjournment of Preconference Workshops
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