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Risk Management Plan (RMP)
All applications for marketing authorisation in the EU must include a detailed and complex Risk Management Plan (RMP). In addition, renewals for older or generic products will require an RMP. Certain variations to the marketing authorisation, may also mean that an RMP is required or an existing RMP requires to be updated. This requirement depends on the nature of the variation and may not be necessary in all circumstances and our expert medical writers and Pharmacovigilance risk benefit specialists can advise both on the need for an abbreviated RMP and on its content. PrimeVigilance can help our clients determine important identified and potential risks for both detailed and abbreviated RMPs.
PrimeVigilance, has extensive experience in writing RMPs, assessing risk benefit analysis, RMP maintenance, and in line with GVP Module V can advise or perform analysis of the effectiveness of the risk minimisation activities.
Brown EG, Goldman SA (Guest Eds). The future is now: Current Concepts in Risk Management. Drug Safety 2004; 27(8)
Risk Management Planning: Compliant and Proactive
– just one of the pharmacovigilance services from PrimeVigilance
For more information contact PrimeVigilance today