Pharmaceutical forum CLINICAL TRIALS IN UKRAINE. EUROPEAN INTEGRATION
Pharmaceutical forum CLINICAL TRIALS IN UKRAINE. EUROPEAN INTEGRATION, is to be held on June 29, 2023. The participants will consider topical issues of optimization of clinical trials in Ukraine, bringing the Ukrainian industry in compliance with the best European and world standards, Good Clinical Practice (GCP) principles, ensuring the protection of the rights and safety of patients.
Venue: Mercure Congress Centre, Kyiv, 6, Vadym Hetman St.
PROGRAMME
Registration and welcome coffee/08:30–09:30
OFFICIAL WELCOME AND OPENING ADDRESS
Moderator: Sergey Orlyk, pharmaceutical market expert
Sergii Dubrov — First Deputy of the Minister of Health of Ukraine (MOH), Doctor of Medical Sciences, Professor, Kyiv/Ukraine
09:30 – 09:40
Mykhaylo Babenko — Director, The State Expert Center of the Ministry of Health of Ukraine (SECMOH), Candidate of Pharmaceutical Sciences, Associate Professor, Kyiv/Ukraine
09:40–09:50
PLENARY SESSIONS — Clinical trials. Principles of GCP are a regulatory pillar of clinical trials in Ukraine during the war. European integration
Realities of clinical trials in Ukraine
Mykhailo Lobas — Deputy Director for Clinical Issues, The State Expert Center of the Ministry of Health of Ukraine (SECMOH), Candidate of Medical Sciences, MBA, Kyiv/Ukraine
09:50–10:00
Compassionate use of medicinal products in Ukraine. Expanded access program
Taras Lyaskovskyy — Head of Pharmaceutical Department, Ministry of Health of Ukraine (MOH), Kyiv/Ukraine
10:00–10:15
Clinical trials in Ukraine today and in the future
Iryna Magdik – Executive Director of Clinical Trials Subcommittee, European Business Association (EBA), Candidate of Medical Sciences, MBA, Kyiv/Ukraine
10:15–10:30
What to do today for the future of clinical trial industry in Ukraine?
Ivan Vyshnyvetskyy, Head of Ukrainian Association for Clinical Research, Associate Professor of Health Care Management Department, O.O. Bogomolets National Medical University, Candidate of Medical Sciences, Associate Professor, Kyiv/Ukraine
10:30–10:45
What is the sponsor of clinical trials doing in Ukraine today?
Serhiy Mykhaylov, Clinical Research Director Ukraine, Georgia & CIS, MSD, Kyiv/Ukraine
10:45–11:00
Use of Clinical Trials Information System (CTIS)
Working language – English
Online
Björn Eriksson – Director General, The Swedish Medical Products Agency (MPA), Uppsala/Sweden
Gunilla Andrew-Nielsen – Head of Department of Clinical Trials and Special Permissions, The Swedish Medical Products Agency (MPA), Uppsala/Sweden
11:00–11:20
Experience of clinical trial conduct during the war
Kateryna Orlovska — Country Clinical Quality Management Lead Ukraine, Georgia and CIS, MSD, Kyiv/Ukraine
11:20–11:35
Procedure for obtaining informed consent is a key element in protecting the rights of research subjects
Olha Smoliar – Head of Preclinical and Clinical Trial Materials Specialized Expert Evaluation Unit, The State Expert Center of the Ministry of Health of Ukraine (SECMOH), Kyiv/Ukraine
11:35–11:50
Organizing the work of the Ethics Committee at CNE Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council
Oksana Sokurets – Head of Ethics Committee at CNE Clinical Center of Oncology, Hematology, Transplantology and Palliative Care, Cherkasy Regional Council/Ukraine
11:50–12:05
Considerations for Ukraine’s Clinical Research Context: Learnings from ALLEA’s Symposium on Crisis and the Importance of Research, the EU-US Trade & Technology Council’s Standardization for Emerging Technologies, and Data Governance in ICH E6(R3)
Working language – English
Online
Francis P. Crawley, Executive Director, Good Clinical Practice Alliance – Europe (GCPA) & Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Leuven, Belgium & UCRSI
12:05–12:20
Lunch/12:20–13:00
PANEL DESCUSSION – Organization of trial site at health care setting and peculiarities of its functioning under martial law. Compliance with GCP requirements. Results of clinical audits
Panelists:
Serhii Rasputniak – Head of Audit of Laboratory and Clinical Practice (GLP, GCP) Board, The State Expert Center of the Ministry of Health of Ukraine (SECMOH), Kyiv/Ukraine
Lesiia Iankova – Head of Clinical Audit of Clinical Trials Department, The State Expert Center of the Ministry of Health of Ukraine (SECMOH), Kyiv/Ukraine
13:00–13:30
Clinical research under extreme conditions. War-tested innovations
Igor Bondarenko – Head of Oncology and Medical Radiology Department, Dnipro State Medical University, Doctor of Medical Sciences, Professor, Dnipro/Ukraine
13:30–13:45
Preclinical studies of medicinal products as the basis of clinical trials. Implementation of ICH and EMA guidelines
Mykhailo Kozlov – Head of Preclinical Studies Audit Sector, Audit of Laboratory and Clinical Practice (GLP, GCP) Board, The State Expert Center of the Ministry of Health of Ukraine (SECMOH), Candidate of Medical Sciences, Kyiv/Ukraine
13:45–14:00
Bioequivalence: components of success
Igor Zupanets – Doctor of Medical Sciences, Professor, Honored Person of Science and Technology of Ukraine in co-authorship with Natalya Bezugla, Associate Professor of Clinical Pharmacology and Clinical Pharmacy Department, National University of Pharmacy, Candidate of Medical Sciences, Professor, Kyiv/Ukraine
14:00–14:15
Investigation of bioequivalence in Ukraine. The situation in the last five years and expected prospects
Nadiia Zhukova, Head of the Bioequivalence and Bioavailability Materials Expert Evaluation Board, The State Expert Center of the Ministry of Health of Ukraine (SECMOH), Candidate of Pharmaceutical Sciences, Kyiv/Ukraine
14:15–14:30
Transferring CT participants from Ukraine to Poland due to the war Working language – English
Online
Michał Gryz – Director of the Department for Inspections of Medicinal Products and Medical Devices, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Warsaw/Poland
Ewa Ołdak, Advisor for Cabinet of the President, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Warsaw/Poland
14:30–14:45
Clinical studies with air alarm accompaniment. Experience of the National Cancer Institute
Yuriy Ostapenko, Head of Minimally Invasive and Endoscopic Surgery, Interventional Radiology Department, the National Cancer Institute, Candidate of Medical Sciences, Kyiv/Ukraine
14:45–15:00
How the war in Ukraine has changed our approach to clinical trials based on our experiences and lessons learned
Working language – English
On-line
Aneta Sitarska Haber, MD, Associate Director, Regional Operational Delivery-Poland, Clinical Research Group, PPD, part of Thermo Fisher Scientific
DISCUSSION OF FORUM TOPICS
Moderator: Sergey Orlyk, pharmaceutical market expert
15:00–15:15
Сoffee Break/15:15–15:35
JOINT SECTION: State Expert Center of the Ministry of Health of Ukraine (SECMOH) & Ukrainian Association for Clinical Research – Ukraine’s capabilities for international clinical trials
Working language – English
Why Ukraine is important for global clinical development
Ivan Vyshnyvetskyy – President of the Ukrainian Association for Clinical Trials, Managing Director, FutureMeds in Ukraine, Kyiv/Ukraine
15:35–15:45
Clinical Trials Sector in Ukraine during the war. Expert Analysis
Taisa Herasymchuk – Director of the Preclinical and Clinical Trials Materials Expert Evaluation Department, The State Expert Center of the Ministry of Health of Ukraine (SECMOH), Candidate of Pharmaceutical Sciences, Kyiv/Ukraine
15:45–16:00
Success story: COVID-19 study in Ukraine during the war
Online
Sebastien Labbe, Director, Preclinical and Clinical Development, Immune Biosolutions Inc.,/Canada
Bruno Maranda – MD, Chief Medical Officer, Immune Biosolutions Inc./Canada
16:00–16:15
Demystifying clinical trial logistics in Ukraine during the war
Olga Vizgalova– Managing Director, Oximio, Kyiv/Ukraine
16:15–16:30
Success story: Ulcerative Colitis study in Ukraine during the war
Online
Jenny Sundqvist – CEO, InDex Pharmaceuticals/Sweden
Eva Arlander – Chief Development Officer, InDex Pharmaceuticals/Sweden
16:30–16:45
What it means to stay operational during the war: clinical sites experience
Evgeny Levenko – Country Manager, ARENSIA Exploratory Medicine, Kyiv/Ukraine
16:45–17:05
Experience of conducting clinical trials in Ukraine during the COVID-19 pandemic and war
Jens D. Lundgren – MD, DMSc, Professor, Director of the Centre of Excellence for Health, Immunity and Infections, Copenhagen/Denmark
17:05–17:20
The role of a laboratory center accredited according to the requirements of ISO 15189 in conducting clinical research
Anastasiia Zhuzhukova – Development Manager of the Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council, Clinical Research Coordinator, Cherkasy/Ukraine
17:20–17:35
PANEL DISCUSSION – Convincing sponsors to re(start) clinical trials in Ukraine
Moderator: Yuriy Lebed – CEO at CRO Pharmaxi LLC, Ukraine
Panelists:
Radoslaw Janiak – CEO of FutureMeds Ltd, UK(online)
Serhiy Mykhaylov, Clinical Research Director Ukraine, Georgia & CIS, MSD/Ukraine
Werner Gladdines – VP, Program Management/Clinical Development Operations, Immunic Therapeutics/Germany (on-line)
17:35–18:10
DISCUSSION OF FORUM TOPICS
18:10–18:20
CLOSING REMARKS
Adoption of Resolution of the Forum Сlinical Trials in Ukraine. European Integration
Oleksandr Gudzenko – Doctor of Pharmaceutical Sciences, Professor, Honored Healthсare Worker of Ukraine, Head of the Agency for Methodological and Scientific and Practical Work, Organizing Committee Co-Chair, The State Expert Center of the Ministry of Health of Ukraine (SECMOH), Kyiv/Ukraine
18:20–18:30
Buffet Dinner/18:30–20:00
