The Ministry of industry and trade of the Russian Federation
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

February 27-28, 2017 Workshop on “GMP Requirements in the pharmaceutical production of biological and immunobiological substances”

On February 27 and 28 FSI State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade will conduct a workshop dedicated to GMP Requirements in the pharmaceutical production of biological and immunobiological substances.

The workshop is aimed at establishing an integrated approach in various aspects of quality control in production of biological and immunobiological substances and their pharmaceutical derivatives. Participants will review the most recent regulatory, organizational and sanitary requirements to the production and control of the life cycle in this specific pharmaceutical group based on pharmaceutical development and quality assurance.

Workshop participants will obtain expertise in the most topical issues of the GMP regulations and will learn to implement particular requirements in the area of pharmaceutical production, quality assurance and control. The workshop agenda has been designed to provide an orderly algorithm of GMP implementation at every lifecycle stage of biological and immunobiological substances and pharmaceutical products (from development through release). Special attention will be paid to specific norms of production and quality assurance in various biological pharmaceutical products, safety control (including viral safety), risk analysis, and pharmacovigilance.

The seminar will be led by Irina Nikitina – Candidate of Economic and Pharmaceutical Sciences. Ms. Nikitina possesses 15+ years of practical experience working in big pharma companies. Professionally, she focuses on management of innovative development, quality control and quality assurance, pharmaceutical products development and registration, marketing authorization in Russia and other countries. Ms. Nikitina is a research fellow at the Federal State Institution “Analytical Center under the auspices of the Government of the Russian Federation”.

Upon completion, all successful participants will receive individual certificates of advanced training.

Location: Moscow, Bryusov per., 2/14, str.8
Contact person: Ekaterina Ryzhikova
Тel: +7 (915) 455-65-78