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Please help our FDAAA Centennial Scholarship fund!
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Now Available
A Time Capsule This
publication features some of the presentations given at our
FDA/Industry in Dialogue Conferences between |
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FDA and Industry in Dialogue
Sponsored by The QA/RA Graduate Program of Temple University’s School of Pharmacy
In Commemoration of the Centennial of the U.S. Food and Drug Administration
Printed September 2007
Suggested donation: $24.95 (which includes shipping within the continental U.S.)
All proceeds will go to the FDAAA Centennial Scholarship, which helps QA/RA students who are not reimbursed for their tuition.
Please consider ordering a copy for your company library to help our scholarship fund!
To order, click here: ORDER FORM
Contents:
Peter Doukas, PhD, Introduction
Wendy Lebing, MALD, MS, History of the QA/RA Graduate Program
Thomas J. Kirsch, The Need for Pre-NDA Interaction
Wendy Lebing, MALD, MS, Graduate Education for RA Professionals
Peter Doukas, PhD, Wendy Lebing, MALD, Richard Brashares, PhD, Salute to FDA……
SPEECHES FROM QA/RA GRADUATION CELEBRATIONS
Diana Kolaitis, Reinventing the FDA (May 1996)
Karyn M. Campbell, BS, The View from the FD (May 1998)
Thomas Gardine, BChE, Working with Industry (May 1999)
Janet Woodcock, MD, The Future of Pharmaceuticals: Challenges to Industry & FDA (May 1999)
PRESENTATIONS FROM TEMPLE UNIVERSITY CONFERENCES:
FDA & INDUSTRY IN DIALOGUE
April 4, 2000:
Janet Woodcock, MD, Cooperative Efforts between FDA and Industry.
David Blois, PhD, Cooperative Efforts between FDA and Industry.
David Lepay, MD, PhD, Clinical Research Quality and Integrity.
Thomas J. Kirsch, MS, Clinical Research Quality and Integrity
Murray Lumpkin, MD, FDA Interaction with Non-U.S. Agencies.
Joseph X. Phillips, FDA Interaction with Non-U.S. Agencies and MRAs
Linda Carter, Financial Disclosure: Recent FDA Guidelines
April 3, 2001
Janet Woodock, MD, Risk Management in FDA Decision-Making
Joseph C. Famulare, MRA Status and Progress/European Community Assessment Visits
Alexander Giaquinto, PhD, Working Towards International Harmonization: the CTD and Timing for its Implementation in the U.S.
April 17, 2002
Janet Woodcock, MD, Counter-Terrorism: Strategies for a Joint FDA/Industry Response
Yuan-Yuan H. Chiu, PhD, BSE and FDA Regulated Products.
Benjamin England, JD, Importing Pharmaceuticals: Product Security for Drugs and Biologics
Robert J. Temple, MD, Early Implications of the European Clinical Trials Directive
Steven K. Galson, MD, MPH, FDA Decision-Making as Risk Management.
April 15, 2003
Janet Woodcock, MD, Scientific Base for Regulation
D. Bruce Burlington, MD, Scientific Base for Regulation
Susan Laska, MS, Quality Systems Approach to Systems Inspections.
C. Greg Guyer, PhD, MBA, Quality Systems Approach to Systems Inspections
John Jenkins, MD, PDUFA III
Timothy R. Franson, MD, PDUFA III: What Do FDA and Industry See as the Next Step?
April 20, 2004
Nancy Smith, PhD, FDA and Industry Today
Paul Seligman, MD, MPH, Risk Management
Janice Bush, MD, Risk Management
Janet Woodcock, MD, Quality Systems
March 29, 2006
Steven K. Galson, MD, MPH, Update from the FDA on Current Trends and Concerns
D. Bruce Burlington, MD, FDA and Industry Today
Douglas L. Sporn, MBA, Solving the Complex Drugs Development Puzzle to Stimulate Pharmaceutical Innovation
Tobias Massa, PhD, Use of Process Analytical Technology in Developing Quality by Design
Robert J. DeLap, MD, PhD, Continuous Marketing Applications
Edmund P. Harrigan, MD, Benefit-Risk Management
GRADUATION ADDRESS JUNE 2006
Thomas Gardine, BChE
