High-quality preparation and updating of Risk Management Plans of a medicinal product – a workshop for applicants and other interested parties was held at the Center.
The participants' main attention was focused on the detailed theoretical and practical aspects of preparing Risk Management Plans (RMPs) – selecting the safety specification taking into account the type of medicinal products, drawing up the pharmacovigilance plan, and selecting risk minimization measures. The grounds and timelines for updating the version in the post-registration period were also considered.
The course of lectures and practical classes was presented to those present by experienced specialists of the Center's Pharmacovigilance Department – Yevheniia Skoryk, Head of the Directorate for Expert Evaluation of Medicinal Product Safety Materials, and Nadiia Savchenko, expert of the Division for Expert Evaluation of Generic Medicinal Product Materials. The training was supervised by the Head of the Agency for Methodological and Scientific-Practical Work of the Center, Doctor of Pharmaceutical Sciences, Professor Oleksandr Hudzenko.
During the theoretical part, the group considered:
- regulatory requirements for the RMP, its structure and concept, the integrated format;
- specifics of developing a risk management plan for a generic medicinal product;
- grounds requiring an update of the RMP for a medicinal product, timelines;
- requirements for the updated PSUR, including for generics.
During the practical part, participants learned to critically analyze and identify the risks of medicinal products (important identified, potential, missing information) taking into account specific clinical cases of use of medicinal products. They went over the main mistakes in preparing RMPs, in planning pharmacovigilance activities, and in planning and implementing risk minimization measures. They received expert answers to their questions.
“In the context of implementing good pharmacovigilance practice and training pharmacovigilance specialists, the training provided by the Center as the authorized body is the most professional in this area. An effective combination of theory and practice makes it possible to deepen the awareness of applicants and substantially improve the quality of safety monitoring of medicinal products authorized for medical use in Ukraine,” – emphasized Oleksandr Hudzenko, Head of the Agency, during the seminar.
For your information, applicants (registration certificate holders) are responsible for having a risk management system for medicinal products. RMPs are submitted for all applications for registration of medicinal products, except for certain cases. To reflect important changes in the safety of medicinal products, updated versions of RMPs are submitted in the post-registration period. The elements of the RMP summary for the public are public and are subject to publication on the Center's website.
In order to inform about the safety of medicinal products, the Center publishes RMP summaries for the public on the official website https://www.dec.gov.ua/patient/2024-rezyume-pur/…
Since the beginning of 2024, PSUR summaries have been published for 540 medicinal products.
