The Center held a seminar for applicants on pharmacovigilance "Risk management system of a medicinal product". The training was organized by the Center's Agency for Methodological and Scientific-Practical Work.
The goal is to deepen knowledge and skills regarding post-registration safety surveillance of medicinal products and the development of a plan of measures for preventing and minimizing risks (lack of efficacy, adverse reactions, undesirable events) of medicinal products, vaccines, and tuberculin that may have a negative impact on patients and public health.
The course of lectures was delivered by specialists of the Center's Pharmacovigilance Department: Yevheniia Skoryk, Head of the Division for Expert Evaluation of Medicinal Product Safety Materials; Halyna Druk, Head of the Unit for Expert Evaluation of Materials on Traditional and Other Medicinal Products; and Yuliia Fedorets, expert of the Unit for Monitoring and Management of Safety Information and PSUR Evaluation.
More than 20 participants joined.
During the training, attendees became familiar in detail with:
- the rules and specifics of preparing risk management plans (RMPs) in accordance with legislative requirements: format, structure, concept, selection of the medicinal product safety specification, post-authorization study measures, routine and additional risk minimization measures;
- ensuring the safety of medicinal products in special populations (children, the elderly, pregnant and breastfeeding women) – in the context of susceptibility to adverse reactions, collection, signal detection and coding of reports, analysis of possible causal relationships, and preparation of RMPs;
- additional risk minimization measures (training programs, controlled access programs for medicinal products, and others) – in which cases they are proposed and will be most effective;
- important aspects of applicants' communication with stakeholders on medicinal product safety issues;
- the applicant's algorithm of actions when preparing and submitting the PSUR summary to the Center.
The seminar emphasized that it is the applicants who bear responsibility for:
- the presence of an appropriate risk management system;
- understanding the safety profile of a medicinal product when it is used in clinical practice;
- continuous monitoring of pharmacovigilance data to determine the benefit/risk ratio of the medicinal product.
In accordance with para. 9 of Section 4 of Chapter V of the Procedure for Pharmacovigilance, risk management plan (RMP) summaries are posted on the Center's website. This information is important for patients and for medical and pharmaceutical professionals who use (take, prescribe, monitor, dispense, consume) medicinal products, and is an important step toward greater transparency and better public access to information on medicinal products. Since this provision was introduced (from March 2023), about 1200 RMP summaries have been published on the website https://www.dec.gov.ua/patient/2024-rezyume-pur/…
Upon completion of the training, all participants received certificates.
We draw your attention to the fact that the next upcoming pharmacovigilance seminar will be devoted to important issues of detecting and analyzing safety signals of medicinal products.
Details and registration at the link https://www.dec.gov.ua/…/30-04-2024-seminar-praktykum…/
