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