Module 9 2024

03/09/2024

Vaccine Regulatory Framework - USA, EU and WHO (2)

WHO

Clinical evaluation of vaccines (Clinical evaluation of vaccines (who.int)) Non-clinical evaluation of vaccines (Non-clinical evaluation of vaccines (who.int)) Regulation of post approval changes to vaccines (Regulation of post approval changes to vaccines (who.int)) www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine standardization/regulation-of-post-approval-changes-to-vaccines Regulation and quality control of vaccines (Regulation and quality control of vaccines (who.int))

Pre-qualification (PQ) for Vx procurement by UN agencies. Assessed by PQ group in WHO.

WHO establishes these guidelines as a proposal to the Member States. The Member States remain sovereign in their decision to implement these guidelines or not, and to implement them partially, fully or adapt them as they see appropriate

W HAT TO LOOK FOR…

The Organisation for Professionals in Regulatory Affairs

35

Specific Considerations for Vaccines

Regulatory Processes Used by Vaccines to Enable Global Access

The Organisation for Professionals in Regulatory Affairs

36

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