On 11 December, participants of the VI All-Russia Congress “Pharmaceutical activities in Russia and the EAEU” discussed the issues of the legal and regulatory framework of pharmaceutical activities in Russia and within the EAEU territory, the topics of control and surveillance as applied to medicinal drugs circulation and protection of intellectual property.
The event was organized with the support of the State Duma of The Russian Federation, the Ministry of Economic Development, the Chamber of Commerce and Industry, the Ministry of Natural Resources and Ecology, the Ministry of Regional Development, the Ministry of Healthcare, as well as other industry agencies.
The Federal Target Program “Pharma-2020” being implemented currently, the Federal Target Program “Pharma-2030” being developed, the draft bill on amendments to the law “On Drugs Circulation”, the system of labeling and cryptosecurity to be put into effect on 01 January, 2020 – all these documents in one way or another impact or change pharmaceutical activities in Russia and the EAEU.
The Congress saw speeches of the representatives of the Eurasian Economic Commission (EEC), the State Institute of Drugs and Good Practices of Minpromtorg of Russia (FSI ‘SID & GP’), the Autonomous Nonprofit Organization “National Pharmacovigilance Research Center”, the Sechenov University, as well as of other industry experts.
Ekaterina Nikiforova, the Head of Drug Manufacture Inspections Department of the FSI ‘SID & GP, spoke about the procedures of inspecting for compliance with GMP standards and explained the procedure of inspecting pharmaceutical companies for GMP compliance. Mrs. Nikiforova also gave recommendations on behalf of the inspectorate how to avoid such non-conformities and spoke about the approach to applying the risk management system in planning of pharmaceutical inspections.