Module 9 2021

23/03/2021

European (EMA) Vaccine guidance Under "scientific guidelines"/"Multidisciplinary: vaccines". Link: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific- guidelines/multidisciplinary/multidisciplinary-vaccines

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EMA Vaccines Guidances …..what to look for  Adjuvants in vaccines for human use  Clinical evaluation of new vaccines  A series of guidelines on influenza vaccines  Pharmaceutical and biological aspects of combined vaccines  Product information for vaccines  Preclinical pharmacological and toxicological testing of vaccines (note: now deleted and there is reference to the WHO guideline on nonclinical evaluation of vaccines)  Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines  Also on Pharmacovigilance of Vaccines: http://www.ema.europa.eu/docs/en_GB/document_library/Sci entific_guideline/2013/12/WC500157839.pdf

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