Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy-Reference-Cited by-同舟云学术

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

Published:2015-09-11 Issue:5 Volume:98 Page:502-505
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Segec A¹,Keller-Stanislawski B²,Vermeer NS³⁴,Macchiarulo C⁵,Straus SM⁴,Hidalgo-Simon A¹,De Bruin ML³⁴

Affiliation:

1. European Medicines Agency; London United Kingdom

2. Department of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich Institute; Federal Institute for Vaccines and Biomedicines; Langen Germany

3. Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology; Utrecht University; Utrecht The Netherlands

4. Medicines Evaluation Board; Utrecht The Netherlands

5. Agenzia Italiana del Farmaco (AIFA); Rome Italy

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/cpt.199/fullpdf

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4. European Commission A Guideline on Summary of Product Characteristics (SmPC) http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf 2015

5. Guideline on Good Pharmacovigilance Practices (GVP) Module V - Risk Management Systems (Rev 1) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf 2015

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