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Guideline on the requirements to the chemical and ...
Committee for Medicinal Products for Human Use (CHMP)3 4 Guideline on the requirements to the chemical and 5 pharmaceutical quality documentation concerning 6 . investigational medicinal products in clinical trials . 7 . Draft . Draft agreed by Quality Working Party
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Q12 Step 2b Technical and regulatory …
www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
European Medicines Agency
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Q7 Q&A - good manufacturing practice for active ...
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www.ema.europa.euThere is no expectation that existing herbal medicinal products on the market will be affected by this guideline, with the exception of traditional herbal medicinal products for human use that were already
Guideline on good pharmacovigilance practices …
www.ema.europa.eu9 December 2013 . EMA/816292/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1)
Guideline on good pharmacovigilance practices (GVP)
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Guideline on good pharmacovigilance practices …
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Guideline for good clinical practice E6(R2)
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Guideline for good clinical practice E6(R2)
www.ema.europa.euGuideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/75 10 Document History 11 First Codification History Date New Codification November
Guideline on good pharmacovigilance practices …
www.ema.europa.euharmful physical or psychological effects [DIR 2001/83/EC Art 1(1 6)]. 74 Adverse event (AE); synonym: Adverse experience 75 Any untoward medical occurrence in a patient or clinical- trial subject administered a medicinal product
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