SID&GP experts participated in the ISPE Eurasian Affiliate pre-conference

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.

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.