New education strengthens Ukraine’s access to safe and effective drugs

During the second week of June, Uppsala is hosting a delegation from Ukraine consisting of twenty participants. The visit focuses on the first of three modules in a new training programme in regulatory science, developed by Uppsala University's Faculty of Pharmacy in collaboration with the Swedish Medical Products Agency. The aim is to strengthen Ukraine’s access to safe and effective drugs and medical devices.

– In spring 2023, the Swedish Medical Products Agency and the State Service of Ukraine on Medicines and Drugs Control entered into a cooperation agreement which, among other things, includes the development of Ukraine’s framework for the authorisation and supervision of drugs and medical devices. Within this agreement, a need for training was identified, and on the initiative of the Swedish Medical Products Agency we have jointly developed the programme Regulatory Science: Methods and Applications Along the Life Cycle of Pharmaceuticals, says Björn Wettermark, Professor of Pharmacoepidemiology, who has just lectured on how scientific evidence for drugs is generated, evaluated, and used as a basis for regulatory decision-making.

The programme is divided into three modules covering regulatory science and practice across the entire lifecycle of drugs. Following a digital kick off in May and the current visit to Uppsala, two further sessions in Sweden will follow for the Ukrainian participants. Over a total of fifteen days, a selection of experts from both the Faculty of Pharmacy and the Swedish Medical Products Agency will deliver lectures, with a strong emphasis on dialogue and workshops.

– This is a very important opportunity for us to learn from best practice and apply it in our own work. Not least since our health authorities in Ukraine will undergo a major reorganisation, but also because of our long-term ambition to integrate into the European regulatory cooperation framework linked to the EMA. Just two days into the course, we have already gained a great deal of valuable knowledge, says Olga Kolesova, who works with marketing authorisation of drugs at the State Expert Center of the Ministry of Health of Ukraine.

The first module runs throughout the week. In the autumn, the Ukrainian delegation will return to Uppsala for module 2: Good Manufacturing, Distribution and Laboratory Practice – Compliance and Inspection Practices, followed by module 3 in December focusing on Regulatory Practice and Pharmacotherapy. If successful, there is an ambition to develop the programme into a master’s or doctoral-level course at the Faculty of Pharmacy.

text and photo: Magnus Alsne