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Guideline Sponsors Responsibilities IMP handling and ...

30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 36606000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 26 April 2018 1 EMA/202679/2018 2 Committees and Inspections Department 3 Guideline on the Responsibilities of the sponsor with 4 regard to handling and shipping of investigational 5 medicinal products for human use in accordance with 6 good clinical Practice and good Manufacturing Practice 7 Draft 8 Adopted by GCP Inspectors working group (GCP IWG) 28 November 2017 Adopted by GMPD Inspectors working group (GMPD IWG)

Good Clinical Practice and Good Manufacturing Practice 8 . Draft . Adopted by GCP Inspectors Working Group (GCP IWG) 28 November 2017 . Adopted by GMPD Inspectors Working Group (GMPD IWG) 5 December 2017 : Consultation of the European Commission Ad Hoc Group On Clinical Trials :

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  Good, Practices, Clinical, Group, Inspector, Working, Good clinical practice, Inspectors working group

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