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Posts Tagged Clinical Trials

UPDATE Transitional IMP QP – Important News

UPDATE Transitional IMP QP – Important News

Updated Guest post by Kastur Patel – Transitional IMP QP Many of you reading this will be aware that the new Clinical Trial Regulation No 536/2014 does not allow for transitional QPs. There are 2 types of transitional QPs, those who were ‘grandfathered’ in the 1970’s and

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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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Latest QP Question

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

Latest QP Scenario Practice

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?

Testimonials

"The knowledge, guidance and advice provided by Alex was excellent. Alex has first hand knowledge of the requirements needed for candidates to be successful QPs and provides a level of training to meet these requirements. I can highly recommend QPQuandry as a service provider"
Alex Hern, Sanofi.

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