On April 29, a webinar was held at the Center for representatives of a specialized research organization on the conduct of preclinical studies of medicinal products. The event on this topic was held under the auspices of the Agency for Methodological and Scientific-Practical Work of the Center for the first time.
The aim is to deepen the awareness of clinical research specialists of the regulatory framework, the stages of preclinical study and development of new medicinal products, and the determination of readiness for the safe use of medicinal products in subsequent clinical trials.
The seminar was held in an offline-online format, chaired by Taisa Herasymchuk, Director of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials. Presentations were given by specialists of the Preclinical Studies Audit Sector and the Preclinical Studies Materials Expert Evaluation Sector of the Center – Mykhailo Kozlov, Nataliia Bohatyrenko, Olena Tur.
The participants were presented with:
- basic principles and requirements for conducting preclinical studies of medicinal products in Ukraine in accordance with current legislation;
- the procedure for conducting audits of clinical studies and inspections of research facilities for compliance with Good Laboratory Practice (GLP);
- guidelines and manuals on preclinical studies implemented and in force in Ukraine in accordance with EMA and ICH requirements;
- specifics of the scope of preclinical study of a medicinal product at early stages (in animals) and at phase III of clinical trials (in humans);
- specifics of the Center’s expert evaluation of preclinical study materials for medicinal products depending on type (hybrid, generic, biosimilars, fixed combinations, vaccines) and application (pediatric, antitumor, advanced therapy products).
The speakers emphasized the following important points regarding preclinical studies:
- must be based on the safe and effective development of new pharmaceutical products;
- be conducted taking into account the principles of bioethics and humane treatment of laboratory animals;
- comply with the requirements of the guidelines on pharmaceutical, preclinical and clinical development for the respective types of medicinal products;
- take into account a comprehensive assessment of pharmacological, biological and toxicological data;
- contain a mandatory conclusion on the possibility of conducting further clinical trials.
In summary, Taisa Herasymchuk emphasized that preclinical studies guarantee the safety of future clinical trials of medicinal products and therefore must be scientifically and ethically justified.
The Center's main priorities in ensuring the quality and further development of preclinical studies in Ukraine are:
- integration of Ukraine into the international system of conducting and monitoring preclinical and clinical trials of medicinal products;
- implementation of international requirements for preclinical studies into the regulatory framework of Ukraine;
- participation in scientific and scientific-practical conferences, conducting seminars for researchers and applicants, including with international participation.
