Process Analytical Technologies Subcommittee of the

Advisory Committee for Pharmaceutical Science

June 12 13, 2002

Gaithersburg Hilton, 620 Perry Parkway

Gaithersburg, MD

AGENDA

Day 1: Wednesday, June 12, 2002

8:30 Call to Order Thomas Layloff, Ph.D., Acting Chair

8:40 Conflict of Interest Kathleen Reedy, Pharm.D., Executive Secretary

8:50 Introduction, Overview, Training Ajaz Hussain, Ph.D., Deputy Director,
and Objectives of Subcommittee Office of Pharmaceutical Science

9:35 Subcommittee Discussion on Training

10:20 Break

10:35 Regulatory Affairs Perspectives Four Industry Speakers

11:30 Subcommittee Discussion on Regulatory Risk

12:00 Lunch

1:00 Open Public Hearing

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

 

  Process Analytical Technologies Subcommittee of the

Advisory Committee for Pharmaceutical Science

June 12-13, 2002

Gaithersburg Hilton, 620 Perry Parkway

Gaithersburg, MD

AGENDA

Day 2: Thursday, June 13, 2002

8:00 Call to Order Thomas Layloff, Ph.D., Acting Chair

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 (joint)

1:30 Product and Process Development WG Chair

1:45 Subcommittee Question and Answers

2:15 Process and Analytical Validation WG 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