On November 14-15, the 6th International Forum "Clinical trials in Russia" of the Adam Smith Institute was held in Moscow. IPHARMA was one of the major sponsors of the conference.
This year, a large pool of interesting speakers including representatives of the Federal Service for Surveillance in Healthcare and the EAEU has been gathered.
The forum was attended by more than 180 participants, comprising employees of pharmaceutical companies, contract research organizations, research centers and national research institutes from all over Russia.
The conference program was diverse and included not only reports, but also interactive discussions and short seminars.
On the first day, the main topic was the conduct of clinical trials under new EAEU regulatory conditions. Participants discussed their concerns about the latest developments in legislation and the specifics of research in the EAEU countries.
The key topics of the second day were the drug safety and pharmacovigilance.
Julia Trakhtenberg, MD, IPHARMA Medical Director, presented a report "Signal management: evidence from case studies". During the presentation, Julia considered the examples of two registered drugs for patients with diabetes mellitus, which after years of use led to serious adverse reactions. These cases became the subject of a detailed multi-year investigation held by regulators, pharmaceutical companies and the scientific and medical community. Thanks to joint efforts and obtaining data from thousands of patients, an objective risk assessment has become possible. Based on international experience, Julia demonstrated the importance of all stages of signal collection and evaluation in pharmacovigilance practice.
After lunch, Natalia Vostokova, IPHARMA Chief Operating officer, moderated a session on various aspects of clinical research.
Within the framework of the session Natalia presented a report "Clinical development of an original drug: the required volume of clinical data and possible ways of optimizing the programme". Natalia covered the main principles of planning the clinical drug development as well as the design errors in various phases of clinical trials. Natalia told how to avoid the mistakes and increase the probability of transition to the next phase of the study, and also described IPHARMA experience in implementation of adaptive design for reducing such risks.
IPHARMA thanks the organizers of the Forum. We were glad to discuss the topical issues of clinical trials organization and conduct among industry professionals and to share our experience of successful realization of research projects.