Athens, GA | March 10 - March 13, 2008 | The Georgia Center
Agenda
THIRTY SECOND INTERNATIONAL
GOOD MANUFACTURING
PRACTICES CONFERENCE
“GMP’s in a Changing World”
An Industry and FDA Perspective on GMP Topics of Current Interest
March 10 - 13, 2008
Sponsored by
The University of Georgia
College of Pharmacy
Georgia Center for Continuing Education
and the
U.S. Food and Drug Administration
DISCLAIMER: ALL Invited speakers have accepted BUT are on a “Subject to Availability” condition
Conference Enrollment Limited to 400 Participants
The University of Georgia College of Pharmacy and the U.S. Food and Drug Administration will co-sponsor the Thirty Second International Good Manufacturing Practices Conference in Athens, Georgia on March 10 - 13, 2008. Speakers from the Food and Drug Administration, pharmaceutical industry and academe will present topics of interest dealing with changing nature of cGMP's worldwide. The tone of the conference will be informal and relaxed. Casual dress is suggested. All presentations and activities are planned to provide ample time for those discussions that make this conference especially valuable.
OBJECTIVES
At the conclusion of this Conference, attending participants should be able to:
- experience an opportunity and environment for constructive discussion of GMP and product quality related issues;
- gain insightful knowledge about forthcoming policies related to pharmaceutical production;
- hear directly from the leaders of the FDA and industry on matters concerning drug, device and biologic production;
- learn more about the recent laws passed by Congress affecting FDA and the Pharmaceutical industry;
- gain knowledge about FDAs approach to current issues like outsourcing and supply chain control;
and
- review and discuss FDA enforcement activities related to the pharmaceutical industry
| Monday, March 10, 2008 | ||
|---|---|---|
| 12:00 - 8:00pm | Registration | Conference Registration Desk |
| 5:00 - 9:00pm | Networking Reception | Hill Atrium |
| Tuesday, March 11 | ||
| 7:00 - 8:30am | Late Registration | Conference Registration Desk |
| 7:00 – 8:30 | Breakfast Buffet | Banquet Area |
| ALL SESSIONS IN MAHLER AUDITORIUM | ||
| Session Moderator: Barbara Wood | ||
| 8:20 a.m. | Conference Orientation - Gary J. Dykstra | |
| 8:30 | Welcome - Malcolm L. Frazier | |
| 8:45 | Discussion of drug issues with Questions and Answers - Andrew von Eschenbach - Jeffrey M. Leiden |
|
| 10:15 | Refreshment Break | |
| Session Moderator: Tor Graberg | ||
| 10:30 | International Issues Affecting Medical Products - Cledwyn Davies - Chad Sheehy | |
| 11:30 | Panel for Questions and Answers - Tuesday Morning Presenters | |
| 12:00 | Networking Luncheon | Banquet Area |
| Session Moderator: Douglas I. Ellsworth | ||
| 1:00 | The NEW G.M.P. Regulations - Joseph C. Famulare - Martin VanTrieste | |
| 2:30 | Refreshment Break | |
| 2:45 | Outsourcing/Supply Chain/Quality Control Issues - Edwin Rivera Martinez |
|
| 4:00 | Panel for Questions and Answers | |
| 5:30 | Adjourn | |
| 6:00 | Social | |
| 7:00 | Dinner | |
| NOTE: HOSPITALITY ROOMS OPEN | ||
| Wednesday, March 12 | ||
| 7:00 - 8:30am | Breakfast buffet | Banquet Area |
| Session Moderator: Maria Guazzaroni Jacobs | ||
| 8:30am | O R A Re-organization - Malcolm L. Frazier |
|
| 9:00 | Factors Critical to Quality Systems – An Industry View - Stephen Brooks | |
| 9:30 | Refreshment Break | |
| 9:45 | Discussion of ICH and Q-8, Q-9, and Q-10 Documents - Dave Chesney - Edwin Rivera Martinez - Tor Graberg |
|
| 11:00 | Panel for Questions and Answers - All Morning Presenters |
|
| 12:00 | Networking Luncheon | Banquet Area |
| Session Moderator: Leigh Hayes | ||
| 1:00pm | Policies and Procedures Affecting Combination Products - Leigh Hayes - James Cohen |
|
| 2:30 | Refreshment Break | |
| Session Moderator: Alan G. Minsk | ||
| 2:45 | Panel discussion on Recent Laws Passed by Congress Affecting Both FDA and the Pharmaceutical Industry - Alan G. Minsk - Steven Silverman - David R. Schoneker |
|
| 4:00 | Panel for Questions and Answers - All Afternoon Presenters | |
| 5:30 | Adjourn | |
| 6:00pm | Social/Reception | Atrium Area |
| 7:00 | Dinner [by Request/Order] | Banquet Area |
| 8:00pm | Dessert Reception | Atrium Area |
| NOTE: HOSPITALITY ROOMS OPEN | ||
| Thursday, March 13 | ||
| 7:00 - 8:00am | Breakfast Buffet | Banquet Area |
| Morning Moderator: Robert Coleman | ||
| FDA GMP UPDATES | ||
| 8:00 | Compliance Update Issues – any or ALL 483 activities - Philip S. Campbell | |
| 8:45 | Update on Compliance - Center for Drug Evaluation and Research - Edwin Rivera-Martinez | |
| 9:30 | Counterfeit Drugs and the Pharmaceutical Industry - Randy McKay | |
| 10:15 | Refreshment Break | |
| 10:30 | Panel for Questions and Answers | |
| 12:00 | Adjourn | |
| 12:00 | Luncheon for Post-Conference Tutorial Participants | Banquet Area |
| POST-CONFERENCE TUTORIAL | ||
| Moderating: Charles G. Gammill | ||
| 1:00pm | Quality by Design and Risk Management - Thomas Garcia - Kelly Canter - John Clark - Nick Buhay | |
| 4:30pm | Adjourn | |
2008 GMP CONFERENCE
PROGRAM ADVISORY COMMITTEE
GARY J. DYKSTRA, Director, Biomedical Continuing Education, College of Pharmacy, The University of Georgia, Atlanta, Georgia
CHARLES G. GAMMILL, Ed.D., R.Ph., Director, Pharmaceutical and Industrial Continuing Education Programs College of Pharmacy, The University of Georgia, Athens, Georgia
BALLARD H. GRAHAM, Divisional Vice-President, Global Compliance, Abbott Laboratories, North Chicago, Illinois
THOMAS E. NEEDHAM, Ph.D., Professor of Pharmaceutics, Department of Biomedical and Pharmaceutical Sciences, University of Rhode Island College of Pharmacy, Kingston, Rhode Island
RONALD F. TETZLAFF, Ph.D., Corporate Vice President, PAREXEL Consulting, Duluth, Georgia
BARBARA A. WOOD, Director, Import Operations, Southeast Region, U.S. Food and Drug Administration, Atlanta, Georgia