Participation in the academic workshop RegLek – EAEU 2018
On May 21-22, experts of the State Institute of Drugs and Good Practices took part in the academic workshop entitled ‘Inspection and registration of pharmaceutical products in the EAEU’ (RegLek* – EAEU 2018) in Moscow.
The newest approach to the evaluation of impurities in medicines became the keynote of the event.
Natalia Chadova, Head of the Inspection Department of the State Institute of Drugs and Good Practices, spoke in the chapter dedicated to ‘Pharmacopoeia of the EAEU’, describing the main stages of auditing drug registration dossiers during GMP inspections. In her report, Natalia noted a large number of identified deviations in 2017: 266 of which were found critical (8%), 1644 – major (47%), and 1593 were categorized as minor (45%).
Participants of the workshop had an opportunity to discuss most of the deviations revealed in drug registration dossiers with Vladimir Orlov, Deputy Head of the Scientific Training Department, and Aleksy Zhilin, Leading Specialist in the Inspection Department. In addition, the delegates took part in the panel discussion, which also covered GMP-inspections issues.
*RegLek (Pharmaceutical Regulation)
- The Director of SID & GP opened a new manufacturing site in Nizino
- Export potential of Russian pharmaceuticals has been discussed at the SPIEF
- By 2022, SID & GP will have developed several pediatric dosage forms
- Good practices in drug quality assurance from development to the consumer
- GMP inspectorates of Russia and Uzbekistan signed an Agreement on Cooperation