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.
For more information contact PrimeVigilance today
+44 (0)1483 307920
(+1) 781 703 5540
United Kingdom (Head Office)