Center specialists led by Mykhailo Babenko took part in the Joint Symposium of the FDA (USA), MHRA (United Kingdom), and Health Canada (Canada) on good clinical practice and pharmacovigilance, “Good Clinical Practice and Pharmacovigilance Symposium,” in an online format.
The event took place on 13-15 February 2024 in Maryland (USA) and was devoted to global clinical trials, good clinical practice, bioequivalence and pharmacovigilance in the post-pandemic world.
The presentations and panel discussions covered the latest updates to ICH E6(r3) and the regulatory prospects for implementing proportionate and risk-based approaches to the design and conduct of trials, which will help ensure sufficient quality of the data obtained for making correct decisions. Participants of the discussions also discussed the ongoing development of new operational approaches, data sources, and technologies used in clinical trials, as well as new approaches to regulatory inspections.
In particular, our specialists became familiar with the following issues:
- continued development of decentralized trials and innovative technologies used in clinical trials;
- the importance of implementing quality management and data management strategies;
- proportionate risks to the safety of trial participants and the reliability of data;
- experience in bioanalytical studies of the FDA and MHRA
- new technologies and related advances in the field of pharmacovigilance;
- prospects of pharmacovigilance inspections.
The knowledge gained is useful in the context of further expert activities, prospects and innovations in the development of areas, strengthening cooperation between regulatory authorities and exchanging information on a global scale.
We sincerely thank the FDA for the invitation and valuable experience.
