Food and Drug Administration
Center for Drug Evaluation and Research
Process Analytical Technologies Subcommittee of the
Advisory Committee for Pharmaceutical Science
Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD
June 12, 2002
AGENDA
8:30 Call to Order: Thomas Layloff, Ph.D., Acting Chair
8:40 Meeting Statement: Kathleen Reedy, RDH, MS, Executive Secretary (acting)
8:50 Introduction, Overview, Training and Objectives of Subcommittee
Ajaz Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Science
9:35 Subcommittee Discussion on Training
10:20 Break
10:35 Regulatory Challenges:
PAT Applications in NDAs : Jeffrey Blumenstein, Ph.D., Pfizer Inc.
PAT Application in ANDAs: Steven Bende
PAT Application Post-Approval: Dhiren N. Shah, Ph.D., Aventis Pharmaceuticals
PAT Validation/GMP issues: Henry Avallone, B.Sc., Johnson & Johnson
11:30 Subcommittee Discussion on Regulatory Risk
12:00 Lunch
1:00 Open Public Hearing:
Justin O. Neway, Ph.D: Aegis Analytical Corporation
Li Peckan, Allan Wilson: The 2080 Group
Dan Klevisha, Tom Tague, Ph.D., Jon Goode, Ph.D: Bruker Optics
2:00 Subcommittee Discussion on Regulatory Risks and Training
3:00 Break
3:15 Subcommittee Discussion
4:30 Working Group Sessions and Strategy
5:00 Adjourn
Food and Drug Administration
Center for Drug Evaluation and Research
Process Analytical Technologies Subcommittee of the
Advisory Committee for Pharmaceutical Science
Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD
June 13, 2002
AGENDA
8:00 Call to Order: Thomas Layloff, Ph.D., Acting Chair
8:10 Meeting Statement: Kathleen Reedy, RDH, MS, Executive Secretary (acting)
8:15 Charge to Working Groups: Thomas Layloff, Ph.D., Acting Chair
8:30 Working Group Discussions
10:00 Break
10:15 Working Group Discussions
11:15 Consensus and Summary Preparation
12:00 Lunch
1:00 Open Public Hearing
Working Group Summaries:
1:30 Product and Process Development: Judy P. Boehlert, Ph.D., Chair
1:45 Subcommittee Question and Answers
2:15 Process and Analytical Validation: Arthur H. Kibbe, Ph.D., Chair
2:30 Subcommittee Question and Answers
3:00 Break
3:15 Subcommittee Discussion
4:15 Summary: Ajaz Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Science
4:25 Closing Remarks: Thomas Layloff, Ph.D., Acting Chair
4:30 Adjourn