Vladislav Shestakov visited Belgium at the invitation of the Eurasian Communication Center
Brussels, April 25. Mr. Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices participated in a meeting of the working group of the Eurasian Economic Commission (EEC) joined by the Eurasian Communication Center, the European Directorate for the Quality of Medicines (EDQM), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Association of International Pharmaceutical Manufacturers (AIPM). New trends, best practices, and problems faced by pharmaceutical markets of the European Union and the Eurasian Economic Union.
Establishing a united EEU market, quality standards, protection of regulatory data, and best GMP-inspection practices were at the heart of the discussion.
In the meeting, Director Shestakov presented a report dedicated to ‘Prospects of GMP-inspections in the EEU, new requirements, trends, and activities’. The speaker described the quality system – which consists of five documentation levels – followed by the Russian pharmaceutical inspectorate. This system is a cornerstone of the quality policy. Further Director Shestakov touched on a number of international projects planned for the nearest future, and called for development of mutually accepted procedures. He concluded by an initiative for compilation of a common deviations classifier and interaction among the Union’s pharmaceutical inspectors, e.g. professional training.
Among other speakers who took the floor were: Valery Koreshkov, EEC Minister for Technical Regulation; Dr. Emmanuelle Charton, Deputy Head of the European Pharmacopoeia Department at EDQM; Nathalie Moll, EFPIA Director General; and Vladimir Shipkov, AIPM Executive Director.
Available of this opportunity Director Shestakov held meetings in Brussels with Karin Froidbise of the Belgic Federal Agency for Medicines and Health Products (FAMHP), and Russia’s Permanent Representative to the European Union.
- Good practices in drug quality assurance from development to the consumer
- GMP inspectorates of Russia and Uzbekistan signed an Agreement on Cooperation
- Typical PQS deficiencies found at drug manufacturers: what does a GMP inspection focus on?
- The Russian and the Chinese GMP inspectorates discussed the prospects for cooperation
- SID & GP together with the Pirogov Russian National Research Medical University (RNRMU) have taken up development of drugs for children