EudraVigilance - EVWEB User Manual
presentation during all phases of the drug regulatory process (i.e. the pre- and post-authorisation phase). These processes include clinical studies, reports of spontaneous adverse reactions, events, regulatory submissions and regulated product …
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www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
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