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Standard operating procedure - European …
Standard operating procedure – PUBLIC SOP/EMA/0083, Page 5/6 9. Procedure Step Action Responsibility 1. Identify services to be outsourced and discuss with Head of
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European Medicines Agency
www.ema.europa.eu© EMEA 2006 2 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS ICH Harmonised Tripartite Guideline
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Guideline for good clinical practice E6(R2)
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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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