In Amsterdam (the Netherlands), on November 16-17, a two-day EMA training on the regulation of medicinal products took place within the European Commission project Instrument for Pre-Accession Assistance (IPA II) – specialists of the Center took part.
The course was devoted to regulatory aspects of clinical trials of medicinal products, pharmacovigilance, and management of medicine shortages, and aimed to facilitate the integration of Ukraine and other potential candidate countries into EU regulatory systems by bringing participants closer to the Acquis Communautaire in the field of medicinal product regulation.
The team of representatives from the Center that joined the offline training in Amsterdam included:
- Director of the Center's Pharmacovigilance Department Tetiana Bashkatova;
- Head of the Directorate for Expert Evaluation of Safety Materials Yevheniia Skoryk;
- Head of the Safety Information Monitoring and Management and PSUR Assessment Division Maryna Lorynets;
- Head of the Division of Clinical Audit of Clinical Studies Lesia Yankova;
- expert of the Division for Quality Expert Evaluation of Clinical Trial Materials of Medicinal Products Dmytro Voronenko.
In online format, representatives of the Ministry of Health of Ukraine, the State Service of Ukraine on Medicinal Products and Drugs Control, and the State Expert Center took part in the training – about 70 participants in total.
Among the topics discussed:
- the new EU Regulation on clinical trials, good clinical practice inspections;
- electronic medical data of patients in pharmacovigilance, safety of medicinal products in special populations.
- PSUSA procedures, risk minimization measures
- management of medicine shortages and communication in the regulation of medicinal products.
During the training seminars, our specialists became familiar with the following topics:
- Management of medicine shortages (speakers Maria Jesus, Tomas Alcaraz and Siofrad McMahon, EMA)
- Communication and stakeholder engagement in medicines regulation (speaker Morgan de Verdier, EMA)
- Assessment of Periodic Safety Update Reports and benefit-risk balance (PBRER) and the procedure for the single assessment of periodic safety update reports (PSUSA) – the speakers were Lina Albakri, Benjamin Pelle (EMA), and Menno van der Elst (Medicines Evaluation Board, MEB (Netherlands)
- Use of real-world data (RWD) in pharmacovigilance and pharmacoepidemiology (speaker Catherine Cohet, EMA)
- Safety of medicinal products in special populations: children, pregnant and breastfeeding women, the elderly (speakers – Viola Macolic Sarinic, Charlotte Backer, EMA)
- Assessing the effectiveness of risk minimization measures (speakers – Maria Escudeiro dos Santos and Thomas Goedecke, EMA)
- Situation overview: provisions on clinical trials (speakers – Laura Pioppo and Iordanis Gravanis, EMA)
- GCP inspections – overview and introduction (speaker – Tiyana Johanna Holmberg, EMA).
After the course, participants will apply the knowledge gained in practice and pass it on to colleagues from competent authorities and other interested parties.
We thank the European Medicines Agency for the important and useful training.
