Quality/Regulatory
A forum for professionals to meet and discuss quality and regulatory related subjects which ensure the products generated in this biotechnology community meet or exceed regulatory standards.
Leadership
CO-CHAIRS
Linda Lemieux, Advanced Cell Technology
Anne Kuan, Javelin Pharmaceuticals, Inc.
James Weston, Alseres Pharmaceuticals
Linda Lemieux, Advanced Cell Technology
Anne Kuan, Javelin Pharmaceuticals, Inc.
James Weston, Alseres Pharmaceuticals
Mission
To provide a forum for Quality and Regulatory professionals to meet and discuss quality and regulatory related subjects which ensure the products generated in this biotechnology community meet or exceed regulatory standards.
Action Plan
To foster cooperation and mutual assistance between Quality and Regulatory professionals within the Massachusetts biotechnology community.
To foster communication and open discussion of topics, issues and ideas of interest to Quality and Regulatory professionals within the Massachusetts biotechnology community.
To foster cooperation and communication with other Massachusetts Biotechnology Council Committees to establish and maintain good working relationships with regulatory authorities.
To foster communication and open discussion of topics, issues and ideas of interest to Quality and Regulatory professionals within the Massachusetts biotechnology community.
To foster cooperation and communication with other Massachusetts Biotechnology Council Committees to establish and maintain good working relationships with regulatory authorities.
Topics
Good Laboratory Practices (GLPs), Good Manufacturing Practices (GMPs), Good Clinical Practices
(GCPs) and clinical trial management relationships associated with:
Regulatory issues associated with:
Quality Control and Quality Management Systems including:
- Research and Development (Pre-IND through Phase III)
- Production (End of Phase III through Commercial)
- On-Going Support Programs
- Contract Manufacturers
- Vendors
- CROs
- Drugs, Biologics and Devices
Regulatory issues associated with:
- Drugs, Biologics and Devices
- Investigational Drugs, Biologics and Device Applications
- ICH Guidelines and International Harmonization
- CANDA/CAPLAS
- Document Management
- International Regulatory Agency Application Reviews and Approvals
- FDA Reform
- CE Marking of Products
Quality Control and Quality Management Systems including:
- ISO Standards and Registrations
- QA Systems and Procedures
- Laboratory Management
- Product Stability Programs
Meetings
| Date | Event |
|---|---|
| 6/11/08 | QA Best Practices In A GLP Environment |
Past Presentations
| Date | Presentation |
|---|---|
| 6/11/08 | QA Best Practices In A GLP Environment- Warrington & Lefebvre |
| 10/23/07 | Combination Products: Regulatory Landscape and Strategies for Success- Sall |
PHONE: 617.674.5100
EMAIL: