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Regulatory Strategies for Post-Approval Change Management for Vaccines

Description

In 2020, PDA started a vaccine initiative to provide more guidance to industry for the development and global supply of vaccines. This Regulatory Strategies for Post-Approval Change Management for Vaccines workstream is one of three new initiatives within the PDA vaccine initiative. This workshop and article will be built on and focus primarily on:

• Establish a linkage to ICH Q12 (possibly Q14 as well))
• Leverage current PDA publications on PAC/Change management)
• Include a proposal for in-country retesting requirements

Biologics sponsors and manufacturers and individuals involved in Regulatory Affairs, Quality Assurance, Product Lifecycle Management, 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 the preparation of a workshop and write/contribute to this article.