Dear colleagues!
Welcome to the pharmaceutical forum
“PHARMEXPERT 2025. eCTD and Pricing in Ukraine – A Strategic Path to Integration into the International Regulatory Space”
On June 17, 2025, a pharmaceutical forum with international participation “PHARMEXPERT 2025. eCTD and Pricing in Ukraine – A Strategic Path to Integration into the International Regulatory Space” will take place in Kyiv.
Organizers: Proxima Research International LLC in cooperation with the State Expert Center of the Ministry of Health of Ukraine.
Format: online, offline (shelter available).
About the Event: The forum is dedicated to key reforms of pharmaceutical regulation in Ukraine. It will focus on implementation of international format eCTD (electronic Common Technical Document) for registration of medicinal products, and the National Price Catalogue for Medicines.
These initiatives are further important steps to digitalize the healthcare sector, increase transparency and efficiency of procedures, standardize processes, and improve patient’s access to quality and effective medicinal products.
Forum key topics:
- International experience of eCTD implementation;
- Regulatory framework for eCTD in Ukraine;
- Practical aspects of eCTD implementation. Market readiness for changes;
- Drug pricing in Ukraine: state price regulation policy, international experience;
- Pricing impact on medicine affordability in Ukraine: challenges and opportunities.
The forum is planned to feature representatives of state bodies (the Verkhovna Rada Committee on National Health, Medical Care and Health Insurance, the Ministry of Health of Ukraine, the State Service of Ukraine on Medicines and Drugs Control, the National Health Service of Ukraine (NHSU), SE “Medical Procurement of Ukraine”, etc.), international organizations, leading European regulators, pharmaceutical manufacturers, specialists from consulting and legal organizations, educators, scientists, interested parties, and patient organizations.
Foreign speakers including representatives of the WHO, European Medicines Agency (EMA), the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), national regulators from Poland, Croatia, Moldova, and other countries, eCTD software vendors invited by the Forum organizers will share their experience and valuable recommendations.
Who should attend this event?
- Pharmaceutical manufacturers;
- Regulatory, registration, legal, and IT specialists from pharmaceutical companies;
- Scientists and healthcare experts;
- Representatives of professional associations, public organizations, and patient organizations.
Why should you attend the event?
- Practical issues of eCTD implementation in Ukraine
The forum will serve as a key platform discussing the lessons learnt during the pilot eCTD submission of registration documents for medicinal products. Participants will have the opportunity to familiarize themselves with real-world experience of applicants, common pitfalls and frequent mistakes to avoid. Special attention will be given to practical recommendations that will help applicants prepare for a full-scale eCTD submission.
- Expert insights: pricing, digitalization, and medicine affordability
International and domestic experts will share their results of an analysis of key aspects of formation of the National Price Catalogue for Medicines, document submission practices for declaring wholesale and retail prices, and impact of new pricing approaches on patient’s access to affordable medicines.
- Valuable networking, experience sharing, and practical solutions for pharmaceutical business
The Forum will provide an opportunity to share experience with colleagues in the pharmaceutical industry, build new partnerships, find solutions for specific business needs, meet representatives ofeCTD software vendors, and stay informed about key changes in the electronic submission for registration of medicinal products.
The detailed program of the event is under development and will be published soon.
Don’t miss the opportunity to contribute to the strategic vision of Ukraine’s pharmaceutical market future!!
Venue: Kyiv.
More information and registration are available on the Forum’s page. REGISTRATION IS OPEN!!
CONTACTS OF ORGANIZERS:
For pricing policy, registration and conditions of participation:
tel. +38 (050) 464-16-40, events@proximaresearch.com
LLC Proxima Research International
For organizational issues:
tel. +38 (044) 202-17-00 (2251), e-mail: amsw@dec.gov.ua
Methodological, Scientific and Practical Work Agency, the State Expert Center of MoH of Ukraine (SECMOH)
The Organizing Committee of the Pharmaceutical Forum
“PHARMEXPERT 2025. eCTD and pricing in Ukraine – A Strategic Path to Integration into the International Regulatory Space”
