Module 19 2021

01/06/2021

Other Regulators

Not a regulator, but WHO Prequalification is becoming a requirement for many previously unregulated markets Focus on key products and diseases such as HIV/Malaria/STD RCP holds but talk to them first Require site audit and established QMS Changes must be communicated and agreed Assessment and maintenance can be large amount of work Approval (WHO Pre-qualification) is becoming a requirement in many previously unregulated markets

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What about the rest of the world?

For the final session we will focus on requirements in other regulated markets

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