SID&GP experts participated in the ISPE Eurasian Affiliate pre-conference
Pre-conference of the Eurasian ISPE Affiliate – online event dedicated to pharmaceutical engineering – took place on December, 16, before the big conference of ISPE EAEU, which is planned to be held off-line in 2021. The pre-conference day was online and brought together leading Russian and foreign experts in the field of pharmaceutical engineering and design. SID&GP experts prepared presentations in a number of panel sessions of the event.
The history of the International Society for Pharmaceutical Engineering development in the EAEU is closely connected with the SID&GP. In 2017 in Barcelona at the ISPE European Conference a meeting was held between the leadership of SID&GP and ISPE, and in July of the same year a delegation of representatives of the pharmaceutical industry with the participation of SID&GP visited the headquarters of ISPE in the United States. Since then, the process of the ISPE Eurasian Affiliate formation and development has gained a new pace, also with the expert support of the SID&GP.
“ISPE events held all over the world are widely known in the pharmaceutical community,” said Vladislav Shestakov, Director of SID&GP in his greeting to the pre-conference participants.
The business program of the ISPE Eurasian Affiliate pre-conference was attended by the experts of SID&GP. In the panel discussion “Pharmaceutical Engineering and Design” took part Igor Falkovsky, Head of the Department for Good Engineering Practice of SID&GP. In his presentation, the head of the Institute’s engineering unit provided mutual expectations of the pharmaceutical manufacturers and engineering companies in the process of making drugs in relation to the project, which in the course of its implementation may undergo significant changes. It is the regulator that can only interpret the licensing requirements. The task of a pharmaceutical company is to ensure that it conforms to the regulator’s expectations and requirements, and the objective of an engineering company – to take the fullest possible consideration of the expectations and requirements of the regulator when designing the pharmaceutical manufacturing.
As part of the session “Improving the regulatory framework of drug manufacturing in the EAEU and the world, and current regulatory trends”, a presentation was made by the Deputy Head of Expert Evaluation Department of the SID&GP Ms. Nadezhda Arkhipova. In her report, the expert presented EAEU leadership’s project on aseptic process in the manufacturing of sterile drugs.
The Conference received much response from the industry, according to the organizers’ figures more than 1200 listeners and experts took part in the Conference, and the number of unique views amounted to approximately 1000.
“I am certain that holding conferences under the auspices of the ISPE on the territory of the EAEU will become an annual event, – expressed hope Director of the SID&GP Vladislav Shestakov. – It is an excellent opportunity for the pharmaceutical industry as a whole and for an engineering sector in particular to discuss issues and trends, to consider new initiatives and develop consolidated proposals.”
- The Cooperation Agreement was signed between State Institute of Drugs and Good Practices and National agency of pharmaceutical products of Algeria
- SID&GP passed the recertification audit of the Quality Management System according to ISO 9001:2015
- Russian Federation has submitted an application for the Pharmaceutical Inspection Co-operation Scheme PIC/S accession
- Signing of Cooperation agreement between FSI “SID&GP” and Agency for medicinal products and medical devices of Bosnia and Herzegovina
- Director of “SID&GP” has introduced the statistics of identified non-conformities in the registration dossier