The risk management plan is a key document of each applicant's pharmacovigilance system. It is part of the registration dossier and defines the safety profile of the medicinal product, approaches to its further study, as well as risk minimization measures and the assessment of their effectiveness.
The RMP accompanies the medicinal product throughout its entire life cycle and is subject to regular updating in accordance with new safety and efficacy data or regulatory requirements.
The training focused on analyzing practical cases, which allowed participants to better understand the requirements for this document and approaches to its preparation.
Specialists of the Directorate for Expert Evaluation of Medicinal Product Safety Materials of the Pharmacovigilance Department delivered presentations.
The speakers paid special attention to the development of RMPs for generic medicinal products – the choice of the safety specification, the formation of the pharmacovigilance plan, and the determination of risk minimization measures.
The knowledge and practical skills gained will contribute to a more systematic approach to preparing Risk Management Plans and updating them in a timely manner in accordance with current requirements.
All seminar participants received certificates of training completion.
