Issue 154 HIGHLIGHTS
Scientific committee and working party activities 5 Other information on COVID-19 6 Other publications 6 Events 7 ... minutes and meeting reports • PRAC - agendas, minutes and highlights • PRAC statistics: December 2021 ... • -CTIS sponsor user training programme virtual meeting, 24 January to 27 January 2022
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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
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Guideline on good pharmacovigilance practices …
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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 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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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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products1/traditional herbal medicinal products
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