As part of strengthening cooperation with the European Medicines Agency, Center specialists were invited for the first time to join the training of the EMA pharmacovigilance inspectors working group.
The two-day online training was aimed at strengthening competencies in pharmacovigilance inspections. Representatives of the EMA and of the regulators of Germany, Belgium, Spain, Canada, Sweden, Switzerland, the Netherlands, Australia, and the USA shared their experience with the Center's inspectors.
The training was attended by the Director of the Center’s Pharmacovigilance Department Tetiana Bashkatova together with experts of the departments for pharmacovigilance system audit and for expert evaluation of materials of traditional and other medicinal products – Mariia Nesterchuk, Kateryna Berezhna, Natalia Usata, Oksana Hlushchenko, Anna Kodenko.
During the seminar, our experts familiarized themselves in detail with the following topics:
- Pharmacovigilance inspections: the role of the EMA and national regulatory authorities;
- Submission of reports of adverse events in clinical trials: when to report to the post-authorization module (EVPM) and when to the clinical trials module (EVCTM) of Eudravigilance. What to inspect during pharmacovigilance inspections and what during a GCP inspection.
- Safety variations: timeframes and when the change is expected.
- Electronic systems and inspections (artificial intelligence (AI) and machine learning from the perspective of Health Canada, safety database validation)
- Inspection efficiency: Power BI for faster preparation and better results
- Experience of invited representatives from non-EU countries – Swissmedic, The Australian Therapeutic Goods Administration (TGA), US Food and Drug Administration (FDA)
- EudraVigilance: a new EudraVigilance report on compliance and data protection when using EudraVigilance has been published
- The Eudravigilance data analysis system (EVDAS) for quality and compliance. Practical examples and demonstration of queries for analysis.
The knowledge gained will contribute to deepening the Center's competencies in conducting pharmacovigilance inspections, and to standardizing and strengthening the compliance of domestic regulatory legislation with EU requirements.
