Food and Drug Administration
Center for Drug Evaluation and Research
ADVISORY COMMITTEE FOR
PHARMACEUTICAL SCIENCE (ACPS)
Manufacturing Subcommittee
July 20-21,
2004
CDER Advisory Committee Conference Room
5630 Fishers Lane
Rockville, MD
TENTATIVE AGENDA
Day 1: Tuesday, July
20, 2004
8:30 Call to Order Judy Boehlert, Ph.D.
Chair,
Manufacturing Subcommittee
Conflict of
Interest Statement Hilda Scharen, M.S.
Executive Secretary, ACPS
Introduction to Meeting Ajaz
Hussain, Ph.D.
Deputy
Director, Office of Pharmaceutical Science (OPS),
CDER, FDA
Topic
Updates - Quality by Design
Updates: (1) ICH Q8 and Q9
(2) Life
Cycle Management for Process and System Control: An Industry Proposal
(3) ASTM E55: Pharmaceutical Applications of
Process Analytical Technology
10:30
Break
Moving Towards the "Desired State": Manufacturing Science and
Quality by Design as a Basis for Risk-based CMC Review
(1) Manufacturing Science and Knowledge
(2) Quality by Design and Specifications
12:00 Lunch
Open
Public Hearing
Risk-based CMC Review Paradigm Under Quality
by Design and Manufacturing Science Framework -- Opportunities, Challenges,
Current Activities, and Next Steps:
(1) Office of New Drug Chemistry (ONDC)
(2) Office of Generic Drugs (OGD)
(3) Risk-Based
Development and CMC
Question-based Review
(4) Topic wrap-up -- goals and
next steps
Committee
Discussion and Recommendations
3:30 Break
Introduction to Bayesian Approaches
Research and Training Needs: The Industrialization
Dimension of the Critical Path Initiative
5:00 Adjourn
Food and Drug Administration
Center for Drug Evaluation and Research
ADVISORY COMMITTEE FOR
PHARMACEUTICAL SCIENCE (ACPS)
Manufacturing Subcommittee
July 20-21,
2004
CDER Advisory Committee Conference Room
5630 Fishers Lane
Rockville, MD
TENTATIVE AGENDA
Day 2: Wednesday, July
21, 2004
8:30 Call to Order Judy
Boehlert, Ph.D.
Chair,
Manufacturing Subcommittee
Conflict of
Interest Statement Hilda Scharen, M.S.
Executive Secretary, ACPS
cGMPs for the
Production of Phase I
Investigational New Drugs (INDs)
Committee
Discussion and Recommendations
10:00 Break
Introduction to Pharmaceutical
Industry Practices
Research Study
Update
on Pharmaceutical Industry
Practices
Research Study
Committee Discussion and
Recommendations
Open Public Hearing
12:00 Lunch
Pilot Model for Prioritizing
Selection of
Manufacturing
Sites for GMP Inspection
Committee
Discussion and Recommendations
3:15 Break
Applying
Manufacturing Science and Knowledge:
Regulatory Horizons
Update : (1) Process Understanding and PAT
(2) Comparability
Protocol
(3) Changes
Without Prior Approval
Meeting
Conclusion and Summary Remarks Ajaz
Hussain, Ph.D.
5:00
Adjourn