Risk Management Plan (RMP)
- RMPs are complex documents required for all new drug submissions within the European Medicines Agency (EMA) region post 2012, as mandated by the EMA guidance on Good Pharmacovigilance Practice (GVP).
- Trilogy has worked extensively on projects supporting major drug programs, involving RMPs for a wide range of therapies and indications.
- Our understanding of the crucial need to describe clearly the risks associated with medicines in the context of their benefits enables us to explain clients’ messages clearly and consistently for the intended regulatory or patient audiences.
- RMPs must comply with the EU template (EU-RMP) and include full product information, a safety specification, a pharmacovigilance plan and risk minimization plan, as well as an RMP Summary for Lay Readers.