Memorandum of intent creates ISPE affiliate in Eurasia
In October 2017, for the first time in its history, ISPE participated in an educational conference at Moscow’s GXP Institute, part of the Russian Federation’s Ministry of Trade and Industry. Past Chair Mike Arnold welcomed the audience via videoconference, and Richard Denk from the ISPE DACH Affiliate delivered the keynote address on aseptic processing and upcoming regulation.
The highlight of the conference occurred when ISPE Vice President of European Operations Thomas Zimmer, PhD, signed a memorandum of intent on behalf of ISPE CEO and President John Bournas, to establish an ISPE Eurasian Economic Union (EAEU) Affiliate.
An ISPE EAEU Affiliate would provide great opportunities to the pharmaceutical community of the union countries, Alexander Sharonov, Director of the new affiliate, told the Russian State Institute of Drugs and Good Practices. “[I]t is the access to the latest technologies and professional knowledge. … Such expertise and the best world experience in the sphere of pharmaceutical engineering are being developed particularly in the ISPE association, which unites more than 18,000 members from more than 90 countries of the world.”State Institute of Drugs and Good Practices. News. 2017. “The Presentation Results of ISPE EAEU Affiliate Opening Ceremony in the Framework of Educational Conference.” http://gilsinp.ru/?news=the-presentation-results-of-ispe-eaeu-affiliate-opening-ceremony-in-the-framework-of-educational-conference-effective-pharmaceutical-production-regulatory-aspects-latest-technologies&lang=en
“We want the professionals working in Russia to be aware [of] and enjoy the same opportunities as foreign colleagues,” added Sergei Tsyb, Deputy Minister of Industry and Trade of the Russian Federation. “ISPE is a nonprofit organization that conducts many educational programs, issues manuals and scientific materials on the design, construction, and operation of pharmaceutical production. Thus, we help our specialists to be at the same educational and professional level with foreign colleagues.”1
The idea of an EAEU Affiliate was first proposed in July 2017, when a delegation of Russian pharmaceutical industry professionals and regulators met with ISPE in Bethesda, Maryland, to discuss the creation of an EAEU Affiliate. The EAEU is an international organization for regional economic integration whose member states are the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic, and the Russian Federation.
Thomas Zimmer, PhD, is ISPE Vice President, European Operations. He previously was Senior Vice President of the Corporate Division, Safety, Quality & Environmental Protection at...
ISPE’s regulatory initiatives and programs bring visibility and solutions to significant regulatory and quality challenges faced by the industry, facilitate the flow of information between ISPE members and global health authorities to find solutions, and promote interaction between regulatory bodies in the interests of harmonization.
We are excited about the 2024 ISPE Annual Meeting & Expo in Orlando, Florida! A special thank you to the sponsors and planning committee for the Hackathon. We appreciate your commitment to ensuring that recent graduates and college students will benefit from this challenging and...
In the dynamic realm of regulatory affairs, a significant transformation is unfolding—a movement that empowers women to assume pivotal roles in decision-making, policy formulation, and leadership.