ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

Manufacturing Subcommittee

September 17, 2003

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

AGENDA

Agenda: September 17, 2003

8:30 Call to Order Judy P. Boehlert, Ph.D., Chair

Conflict of Interest Hilda Scharen, Exec. Sec.

8:45 Introduction to Meeting Ajaz Hussain, Ph.D., Deputy Director OPS

9:00 PQRI/FDA Workshop Report Summary Tobias Massa, Ph.D.

9:15 Defining Quality Janet Woodcock, MD, Director CDER

9:30 Considerations for "Quality by Design" G K Raju, Ph.D.

10:00 Current Regulatory Challenges in

Assessing "Quality by Design" Norman Schmuff, Ph.D.

10:30 Break

10:45 Proposals for Regulatory Assessment of "Quality by Design"

Industry - PhRMA Gerry Migliaccio

- GPhA Gordon Johnston

Academic Kenneth Morris, Ph.D.

Regulatory - GMP Joe Famulare

- CMC Ajaz Hussain, Ph.D.

11:45 Open Public Hearing

12:45 Lunch

1:45 Committee Discussion and Recommendations

2:45 Break

3:00 Quality by Design and Risk Based Regulatory Scrutiny

CMC: Specifications and Post-Approval Changes Colin Gardner, Ph.D.

GMP: Greg Guyer, Ph.D.

4:00 Committee Discussion and Recommendations

4:45 Closing Remarks Ajaz Hussain, Ph.D.

5:00 Adjourn