Nare Simonyan, regulatory affairs and clinical trials specialist on Kolabtree, provides a Risk Management Plan (RMP) template that medical devices and pharma companies can use as a reference point for their product submissions.
What is a Risk Management Plan (RMP)?
A Risk Management Plan or RMP is a document that details the medicinal product’s safety features, particularly the contingencies in place to reduce its risk severity amongst patients. The RMP template document also requires companies to elaborate on how they will be involved in on-going studies to minimize or prevent risks and enhance the safety of the medicine.
Why do you need an RMP template?
Companies are required to submit a Risk Management Plan to the governing medical bodies, such as the European Medicines Agency (EMA), whilst applying for market authorization. In addition, any national competent authority (NCA) are eligible to request an RMP for medical products that are nationally authorized.
This free RMP template will act as a reference point when you need to submit a Risk Management Plan for your new product.
This RMP template was drafted by Kolabtree freelancer Nare Simonyan. a freelance regulatory consultant with a PhD in pharmaceutical science. She offers consulting expertise across a wide variety of subjects, such as clinical trials, regulatory compliance, scientific writing and medical reviewing. Contact Nare directly here.
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