Urgency of the dialogue between representatives of regulatory and expert authorities on the one hand and pharmaceutical manufacturers and research organisations on the other hand is due to the new legislation of the Eurasian Economic Union (EAEU) in the sphere of harmonisation of the requirements to medicinal products circulation.
Such opportunity within the framework of the V All-Russian Conference with international representation “Urgent Issues of Pre-Clinical and Clinical Research of Medicinal products, Biomedical Cell Products and Medical Devices Clinical Trials” was offered on June 1–2, 1017 by the First St.-Petersburg State Medical University named after I.P. Pavlov.
Delegates from the Russian Federation, Republic of Belarus, Republic of Armenia, the Netherlands, and Kirghizia took part in the conference. The participants included representatives of pharmaceutical companies, state educational and scientific institutions, regulatory and expert authorities, contract organisations and insurance companies.
The conference addressed the ways of enhancement and quality improvement of pre-clinical and clinical trials of medicinal products, biomedical cell products and medical devices. Much attention was paid to regulatory requirements harmonisation in the countries of EAEU and modern approaches to healthcare technologies assessment in clinical research.
Liudmila Alekseevna Yurgel, Lead Specialist of the Medicines Expertise Department of the Republican Clinical and Pharmacological Laboratory with the Centre for Examinations and Tests in Health Service Unitary Enterprise, dwelled on practical aspects of expertise during registration of medicinal products in the Republic of Belarus. As our country may be considered referent with regard to registration of medicinal products according to the EAEU rules, her presentation “Expert Assessment of Clinical Trials Results during Registration of Medicinal Products in the Republic of Belarus” aroused much interest. The presentation gave examples of mistakes made during assessment and interpretation of results of clinical trials, as well as recommendations for their correction. The listeners’ attention was drawn to importance of analysing the State Register of Medicinal Products, obtaining scientific consultation and/or drawing analytical expert review with the involvement of competent specialists, adequate and justified volume of pre-clinical studies, research program development, careful choice of clinical, analytical and statistical base, thorough monitoring of studies, proper execution of documents.
Another point of interest among the participants was discussion of pressing problems of organisation and performance of pre-clinical and clinical trials of medicinal products in a roundtable format where a discussion with representatives of the Ministry of Health of the Russian Federation and the Scientific Centre for Evaluation of Medical Devices Federal State Budgetary Institution with the Ministry of Health of the Russian Federation was held.
Such high-level events make it possible not only to share achievements of pharmaceutical manufacturers and research organisations, but also to discuss all issues, get answers to questions on existing and new regulatory documents within the legal and regulatory framework in the EAEU countries.