In 2020, PDA started a vaccine initiative to provide more guidance to industry for the development and global supply of vaccines. This Accelerated Development and Manufacturing Strategies workstream is one of three new initiatives within the PDA vaccine initiative. This workshop and publication will primarily cover:
- Leveraging platform approaches and prior knowledge
- Running activities in parallel on a risk-based approach
- Facility implications/relationships for accelerated development and manufacturing
- Stability data requirements
Biologics sponsors and manufacturers and individuals involved in Regulatory Affairs, Quality Assurance, Operations and Manufacturing, Validation, Consultants, International Health Authority Reviewers and Inspectors are being sought.
Members of this workstream should have some subject matter expertise, and be willing to help write/contribute to the workshop and publication.
- Technical Writing/Editing
- Process Engineering
- Quality & Compliance