Module 9 2024

03/09/2024

WHO Guidelines to watch for…

• 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)) o 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)) ⚫ Remember that 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

The Organisation for Professionals in Regulatory Affairs

67

Further Information on Technical, Non-clinical and Clinical

The Organisation for Professionals in Regulatory Affairs

68

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