Mr. Vladislav Shestakov called for taking a quantum leap in GLP
The innovative breakthrough is only possible provided there is close cooperation between patients, regulators, scientists and the industry. Such a statement laid down the basis of the 14th international conference «Pharmaceutical Business in Russia».
In Moscow, the annual conference dedicated to the topic of pharmaceutical business development in Russia was started. Usually, it is the platform for regulators, experts, drug manufacturers and researchers to define the prospects of market development in the year ahead. In particular, the Director of FSI «SID & GP» Mr. Vladislav Shestakov emphasized that, from the regulation point of view, Russia had to take a quantum leap in pre-clinical trials.
«Today, many foreign regulators do not rely on pre-clinical trials carried out in Russia,» said Mr. Vladislav Shestakov. «Russia lacks an effective system of regulations in terms of pre-clinical trials, even though Good Laboratory Practice (GLP) was first introduced in Russia more than 15 years ago. The key issues in the pharmaceutical industry have remained the same through many years. These are absence of a clear logical system of requirements and recommendations for pre-clinical and clinical trials, low quality of laboratory animals, unsatisfactory conditions of their managing, absence of the rationale for drug dose calculation and selection of study methods, a lack of competent professionals. This list is far from being definitive».
Besides, the Deputy Head of the Russian State GMP Inspectorate mentioned a recent meeting with the Head of EDQM where the topic of step-by-step implementation of the best practices in Russia was discussed. The Director of FSI «SID & GP» truly believes that the national pharmaceutical industry should switch to implementing not only GMP, but other good practices as well.
- Director of “SID&GP” has introduced the statistics of identified non-conformities in the registration dossier
- SID&GP Director took part in the meeting dedicated to pharmaceutical manufacturing localization in the Ryazan region
- Russian GMP-Inspectorate. Summary of “Pharma-2020”
- SID & GP took part in a Conference in honor of the EMA’s 25th Anniversary
- Industry solidarity in training of pharmaceutical personnel