Risk Management Plan: An Expert Analysis of Changes to the EAEU Good Pharmacovigilance Practice Requirements for the Content and Submission of the Document
Author:
Affiliation:
1. Scientific Centre for Expert Evaluation of Medicinal Products
Publisher
SCEEMP
Subject
General Medicine
Reference6 articles.
1. Komissarova VA. Risk minimization measures in pharmacovigilance: review of national and international experience. Good Clinical Practice. 2019;(3):33–43 (In Russ.). https://doi.org/10.24411/2588-0519-2019-10081
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3. Castañeda-Hernández G, Sandoval H, Coindreau J, Rodriguez-Davison LF, Pineda C. Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: a Latin American survey. Pharmacoepidemiol Drug Saf. 2019;28(8):1035–44. https://doi.org/10.1002/pds.4785
4. Asetskaya IL, Zyryanov SK, Kolbin AS, Belousov DYu. Pharmacovigilance system in Eurasian Economic Union. Good Clinical Practice. 2018;(4):53–72 (In Russ.). https://doi.org/10.24411/2588-0519-2018-10059
5. Vermeer NS, Duijnhoven RG, Straus SMJM, Mantel-Teeuwisse AK, Arlett PR, Egberts ACG, Leufkens HGM, Bruin MLDe. Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe. Clinical Pharmacology & Therapeutics. 2014;96(6):723–31. https://doi.org/10.1038/clpt.2014.184
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1. Analysis of Errors Identified during Regulatory Review of Risk Management Plans Submitted as Part of Registration Dossiers;Safety and Risk of Pharmacotherapy;2023-10-13
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