Navigating Risk Management Plans (RMPs) in the Evolving Regulatory Landscape

International Pharmaceutical Industry
August 2018
Prashant Dhanavade, Sciformix – A Covance Company

Pharmacovigilance (PV) is a vital part of healthcare and for monitoring the benefit-risk profile of medicinal products. The purpose of the European Medicines Agency’s (EMA’s) risk management plan (RMP) is to “document the risk management system considered necessary to identify, characterise and minimise the important risks of a medicinal product” and thus to help sponsors plan their PV and risk minimisation strategy. This article, by Dr Prashant Dhanavade from Sciformix, explores the continuously changing regulations and procedures in PV worldwide.

Regulations and procedures in PV are continually evolving and changing worldwide. On 30 March 2017, the EMA published Revision 2 to the RMP template, requiring that all EU-RMP submission post 31 March 2018 use the new template. Significant changes have been introduced in the revised template, which has been used by some since its announcement and is the subject of much discussion in the industry. The complexity of the new RMP template has introduced significant challenges to preparing high-quality and compliant documents that meet all of the requirements. This article discusses the different challenges posed by the new RMP template and how to navigate them successfully.

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