On December 16, the ISPE Eurasian Affiliate will hold online pre-conference where international experts and regulators of the Eurasian market will discuss specifics of engeneering pharmaceutical production and regulatory trends in an unstable environment.
The second wave of COVID-19 is bringing the event industry back online. Therefore, the organizing committee of the I Annual Conference of the ISPE Eurasian Affiliate, postponing the conference to a later date, will hold its pre-conference day on December 16. During the day Igor Falkovsky, Head of Engineering and Design Department of State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of Russia, will present an overview of the key inconsistencies identified during the qualification of DQ projects of pharmaceutical industries, and Nadezhda Arkhipova, Deputy Head of the Expertise Department of the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of Russia, will talk about key provisions of the EAEU Guidelines on Aseptic Processes in Production of Sterile Medicines. In addition, the online event program will provide an overview of the current ISPE guidelines:
● Alexander Belinskiy, Head of Validation Department of “LabPromEngineering” LLC, will analyze provisions of the new ISPE Guidelines “Good Practice Guide: HVAC & Process Equipment Air Filters”
● Head of pharmaceutical projects BWT Russia Sergey Movsesov will review and give recommendations on practical application of ISPE guidelines “Good Practice Guide: Critical Utilities GMP Compliance”
● Jean-François Duliere, Senior Regulatory Expert, Chairman of the ISPE France, will talk about changes to the EU GMP Annex 1: Review of the 2nd version of the draft document as of December 2020
● Alexander Alexandrov, President of Vialk Group, will present key provisions of the ISPE Good Practice Guide: Process Validation
● Jiri Moninec, Director of ISPE Czech Republic and Slovakia, GMProject (Czech Republic), will review the ISPE Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition.
Among the experts and representatives of regulatory agencies who confirmed their participation:
Dmitry Rozhdestvensky, Head of Division for Coordination of Work in the Field of Circulation of Medicines and Medical Devices of Technical Regulation and Accreditation Department of the EEC, with an overview of the current changes in the EAEU regulatory legal acts regarding the circulation of medicines for 2020.
Head of Department for Inspection of Good Pharmaceutical Practices of the Scientific Center for the Expertise of Medicines and Medical Technologies of the Ministry of Health (Republic of Armenia) Mkrtich Shakaryan will give practical advice on the application of the EAEU regulations in the field of GM (D) P
expert in the field of FGC Zdenek Pavelek (Czech Republic) will share his experience in applying a risk-based approach to the organization of preventive maintenance and repair.