Speech at the scientific-practical conference “RegLek-2017”
On November 23, 2017 in Moscow, a scientific-practical conference “Modern approaches to the expertise of medicines” RegLek – 2017 took place. The conference program has covered the most up-to-date issues of registration and expertise of medicines.
At the conference plenary session, Vladislav Shestakov, the Director of FSI “SID & GP”, gave a presentation on the topic “Analysis of technological documentation while medicines registration”, in which he presented the inspection results at the stage of the regulatory documentation review.
During the scientific-practical conference, the participants were acquainted with the procedure of expertise and registration of medicines within the framework of the national legislation of the Russian Federation and the requirements of the Eurasian Economic Union, from the position of an expert institution, and also investigated the following issues in details:
- Principles of the examination conduct within the framework of the national legislation of the Russian Federation.
- Analysis of changes in the national legislation and their impact on the medicines circulation launch.
- Theory and practice of combining approaches to the expertise of medicines in the framework of the national procedure and rules of the Eurasian Economic Union.
- Expertise in the reference state and in the state of recognition: experts’ risks, pros and cons for registration applicants.
- Integration of the medicines expertise rules of the Eurasian Economic Union into the complex work system of the expert institution of the Russian Federation”.
Upon the event completion Natalia Chadova, Head of Pharmaceuticals Production Inspection Department of FSI “SID & GP”, shared her experience in the framework of the round-table “Medicines expertise: role and responsibility of an expert institution and applicants”, answering to the most current questions of the conference participants.
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed