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Posts Tagged Volume 10

EMA issues new guideline on IMPD for Biologicals

EMA issues new guideline on IMPD for Biologicals

The EMA have published the new guideline on what needs to be included in each section of the Investigational Medicinal Product Dossier (IMPD) [sometimes called the CMC section, stands for Chemistry, Manufacturing and Control; may also be called the CTD for Common Technical Dossier] of the Clinical Trial

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What are the requirements for unlicensed medicinal products in the UK, do you need QP certification? Where would you find guidance?

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Iron Oxide - used as an excipient in many of your products. You find that the supplier has been irradiating the material without your knowledge. What implication does this have for your product? What does this mean for the effectiveness of your supplier oversight and PQS?


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