FDAs Pharmaceutical Quality Initiatives Implementation of a Modern Riskbased Approach Cosponsored wi

1
FDAs Pharmaceutical Quality Initiatives
Implementation of a Modern Risk-based Approach
Co-sponsored with AAPS and ISPE February 28 to
March 2, 2007 Welcome

2
Purpose

• Report FDAs Quality initiatives and recent
  progress
• From FDAs Council on Pharmaceutical Quality
  updates on implementation challenges and
  remaining issues
• Input and Recommendations from Stakeholders

3
The Program

• SESSION I
• Overview of the Initiative
• Quality by Design
• Pharmaceutical Quality Systems
• Breakout Sessions

4
Program

• SESSION II GMPs and Product Review
• GMP oversight within the Quality Initiative
• GMP Inspection Program in the future
• CBERs integration of GMP and Application Review
• Quality Assessment Initiatives
• Presentations, panels and breakout sessions

5
Program

• Session III
• Breakout Session Summaries
• The Path Ahead
• Panel Discussion

6
Acknowledgements

• Steven Kozlowski, M.D., FDA
• Anthony Lubiniecki, Sc.D., Centocor
• Thomas Lynch, J.D., Ph.D., Talecris
• Karen Main, Ph.D., AstraZeneca
• Elaine Morefield, Ph.D., FDA
• Gene Murano, Ph.D., Genentech
• Joseph Phillips, ISPE
• Carol Rehkopf, FDA
• Edwin Rivera-Martinez, FDA
• Raymond Scherzer, Ph.D., GlaxoSmithKline
• Susan Setterberg, FDA
• Helen Winkle, FDA
• Timothy Wozniak, Ph.D., Eli Lilly
• Diane Zezza, Ph.D., Schering Plough

• Planning Committee
• Moheb Nasr, Ph.D., FDA, Co-chair
• Gerry Migliaccio, Pfizer, Co-chair
• Ferdinando Aspesi, Ph.D., Wyeth
• Richard Bowles, III, Ph.D., Schering Plough
• Susan Cady, M.S., Intervet
• Douglas Ellsworth, FDA
• Raafat Fahmy, Ph.D., FDA
• Joseph Famulare, FDA
• John Hennessey, Jr., Ph.D., Merck
• Charles Hoiberg, Ph.D., ISPE
• Frank Holcombe, Ph.D., FDA
• Robert Iser, M.S., FDA
• Nirdosh Jagota, Ph.D., Wyeth
• Gordon Johnston, GPhA
• Christopher Joneckis, Ph.D., FDA

7
Acknowledgements

• Co-sponsors
• American Association of Pharmaceutical Scientists
• International Society for Pharmaceutical
  Engineering
• CDER Supporting Staff
• David Morley
• Kathleen Jordan

8
Breakout Sessions

• Five separate sessions running concurrently
• Will be repeated three times
• One hour per session
• 15 minutes between each session
• Wednesday Sessions A,B,C,D E
• Thursday Sessions F,G,H,I, J
• Start at 130 pm today

9

Breakout Session Format

• Brief Presentation
• Shared Understanding Agreements
• Remaining Challenges
• Recommendations
• Strategies to implement agreed-upon issues
• Proposals to resolve remaining challenges

10
Ground Rules for Breakout Sessions

• We will use a brainstorming format
• All ideas are useful
• You are encouraged to think outside the box
  with a vision of what the future could be and how
  we can facilitate implementation
• Think both short term and long term, and
• Avoid war stories about why things dont work
• Participation from all segments

11
The Question Box

• Where
• How
• When

12

• Thank You