Training Turkey's Regulators - an Affirmation of Global Citizenship
Antonio Moreira, PhD, is unequivocal about ISPE’s need to encourage members and colleagues around the world. “They have their challenges regarding travel and sometimes political unrest, so anything we can do that demonstrates ISPE’s commitment to support all who count on us, regardless of location, for scientific and technical knowledge transfer is essential,” says the ISPE Board member and Vice Provost for Academic Affairs, University of Maryland, Baltimore County. He calls this obligation “an affirmation of ISPE’s global citizenship.”
Fellow Board member Fatma Taman, Chair of the ISPE Turkey Affiliate and based in Istanbul, concurs. “We are Turkey’s leading association for technical pharmaceutical training. Every effort we can make, every gesture, makes a difference,” she said.
Taman and Dr. Moreira have spearheaded a training video initiative with the Turkish Medicines and Medical Devices Agency (TMMDA). Their first session, which lasted five hours, was hosted on 20 March at ISPE headquarters in Bethesda, Maryland. A group of 35 new and experienced professionals participated from TMMDA’s office in Ankara, Turkey’s capital, and the overwhelmingly positive response will result in the creation of a training program for the agency.
“There is interest in a course on inspections,” said Taman, “and Tony and I are developing one for a follow-up session.” In fact, Taman and Dr. Moreira are developing a curriculum for intensive and short courses, with a focus on biotech.
Timing Was Just Right
With Turkey’s recent boom in biologics—there are currently 18 companies investing in biotech—the TMMDA requested training in biologics, biosimilars, and their registration procedures. “When the ISPE colleagues from Turkey approached the Board of Directors for support, a number of us responded positively,” said Dr. Moreira.
Once the political environment became more precarious, however, and corporations imposed travel embargos, the Board had to think of alternatives. Dr. Moreira, who has extensive experience with a variety of training media, suggested videoconferencing. “Fatma and I started talking about developing a program around biotech; we developed an outline, and presented it to the Turkish regulators.” The TMMDA liked what they saw, and both teams coordinated the Bethesda–Ankara videoconference session.
The program was focused on biotechnology: registration of biologics, differences between FDA and EMA biosimilar registration procedures, biosimilar product development, and studies of FDA-approved biosimilars. There was also a translator on hand to lend support. “We had more material than we could cover, and more questions than we could answer in one day of training,” said Taman, “yet the level of engagement was overwhelming.”
Following the session, which included Taman’s introduction of ISPE and the Turkey Affiliate, the 35 TMMDA participants and Dr. Hakkı Gürsöz, the head of the agency, became ISPE members.
ISPE has published a new Good Practice Guide: Critical Utilities GMP Compliance—How to Be Compliant and Ready to Prove It. Written and reviewed by a team of experts from around the world, the guide is the first of its kind in the industry. Team co-leads Nik Krpan and Rod Freeman talked with...
In March 2020, the ISPE Eurasian Economic Union (EAEU) Affiliate was officially established. This event was a significant step along the journey to integrate members from Eurasian Economic Union nations into the international pharmaceutical community, as well as another sign of progress in the...