Risk Management Plan (RMP)
Applications for marketing authorisation in the EU may require submission of a detailed and complex Risk Management Plan in accordance with extensive regulations. This requirement depends on the nature of the product and may not be necessary in all circumstances and our expert consultants are available to advise both on the need for an RMP and on its content. They can discuss the nature of any identified and potential risks with the client company – and with regulators if necessary - and advise on any need for further pharmacovigilance activities after marketing and on the need for risk communication and minimisation programmes.
PrimeVigilance, together with our consultants, is well-placed to write the RMP itself1. Pitching the RMP at just the right level can be critical if delays in product registration due to an inadequate plan are to be avoided. Equally, avoiding commitment to unnecessary post-marketing pharmacovigilance and risk minimization activities may result in major cost savings.
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
For more information contact PrimeVigilance today