Transcription of Guideline on safety and efficacy follow up RMP for ATMP
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Guideline on safety and efficacy follow up RMP for ATMP
1 25 January 2018. 2 EMEA/149995/2008 3 Committee for Medicinal Products for Human Use (CHMP). 4. 5 Guideline on safety and efficacy follow -up and risk 6 management of Advanced Therapy Medicinal Products 7 Draft Adoption by CHMP November 2008. Date of coming into effect 31 December 2008. Adopted by PRAC November 2017. Adopted by CAT January 2018. Adopted by CHMP for release for consultation January 2018. Start of public consultation 01 February 2018. End of consultation (deadline for comments) 30 April 2018. 8. 9 This Guideline replaces ' Guideline on safety and efficacy follow -up - risk management of Advanced 10 Therapy Medicinal Products' (EMEA/149995/2008).
The consequences of non-compliance with the pharmacovigilance and risk minimisation activities . 79. ... 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 128. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro ...
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