CBER Foreign Regulators Seminar
October 14 - 16, 2008
Draft Agenda
| Tuesday, October 14, 2008: |
| Welcome |
Karen Midthun, M.D.
Deputy Director (Medical)
Office of the Director
CBER, FDA |
| Opening Remarks |
Murray M. Lumpkin, M.D., Deputy Commissioner for International and Special Programs, Office of the Commissioner/OIP, FDA |
Day 1 Sessions:
- Seminar Overview and Administrative Matters
- Introduction of Seminar Participants
- CBER Overview: Mission, organizational structure, scope of responsibilities
- Laws, Regulations and Guidances
- Research at CBER
- Pre-licensure Vaccine Review
- CBER’s Safety Surveillance for Biological Products
- Vaccine challenges: Regulatory Issues in Malaria Vaccine Development
- Vaccine lot release
- PANEL and Question/Answer Session: Office of Vaccines Research and Review
|
| Wednesday, October 15, 2008: |
Day 2 Sessions:
- Office of Cellular, Tissues and Gene Therapies: Overview
- Human Tissue Framework
- Cell Therapy Product Review
- Gene Therapy Product Review
- Preclinical Considerations in Cell and Gene Therapy Product Development
- Early Clinical Study Issues in Cell and Gene Therapy
- Product Jurisdiction
- Combination Product Review Issues
- FDA Genomics Program Overview
- PANEL and Question/Answer Session: Office of Cellular, Tissues and Gene Therapies
|
| Thursday, October 16, 2008: |
Day 3 Sessions:
- Compliance and Product Quality: Overview
- Inspections (Pre-approval, Good Manufacturing Practices [GMP], For-Cause); Team Biologics
- Bioresearch Monitoring; Good Laboratory Practices (GLPs)
- Blood/Blood Products: Overview
- Plasma Derivatives Safety Review
- Non-Blood Screening Device Safety Review
- Blood Screening In-Vitro Diagnostics (IVDs)
- Safety Aspects of FDAAA (Food and Drug Administration Amendments of 2007)
- PANEL and Question/Answer Session: Office of Blood Research and Review
|
For more on the CBER Foreign Regulators Seminar
Send emails to: CBERForReg@fda.hhs.gov
