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Guideline on reporting serious breaches

occurred, it is expected to report the serious breach first, within 7 days, and investigate and take action simultaneously or after the notification. In this case, the sponsor should not wait to obtain all of the details related to the breach prior to the notification. In …

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Q12 Step 2b Technical and regulatory …

www.ema.europa.eu

ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36

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Guideline on good pharmacovigilance practices …

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Guideline on good pharmacovigilance practices (GVP)

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Guideline on good pharmacovigilance practices (GVP) – Module IX (Rev 1) EMA/827661/2011 Rev 1 Page 2/25

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Guideline on good pharmacovigilance practices …

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Guideline on good pharmacovigilance practices (GVP) – Module VIII (Rev 3) EMA/813938/2011 Rev 3 Page 2/28

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Guideline for good clinical practice E6(R2)

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Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification

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Guideline for good clinical practice E6(R2)

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Guideline on good pharmacovigilance practices …

www.ema.europa.eu

harmful 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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European Medicines Agency

www.ema.europa.eu

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products1/traditional herbal medicinal products

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Q7 Q&A - good manufacturing practice for active ...

www.ema.europa.eu

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