PRESENTATIONS
sixth scientific and practical conference with international participation
“CLINICAL TRIALS OF MEDICINAL PRODUCTS IN UKRAINE: NEW CHALLENGES AND RESPONSES TO THEM”
8-9 October 2020
8 OCTOBER 2020
Opening ceremony of the conference
- Vitalii Tsymbaliuk
- NAMS of Ukraine, Corresponding Member of the NAS of Ukraine, President of the NAMS of Ukraine, Kyiv, Ukraine
- Ihor Ivashchenko
- Deputy Minister of Health of Ukraine for European Integration, Kyiv, Ukraine
- Tetiana Dumenko
- Director of the State Expert Center of the Ministry of Health, Kyiv, Ukraine
- Serhii Mykhailov
- Director of Clinical Research, MSD Ukraine LLC, Kyiv, Ukraine
Plenary session
1. Prospects for improving the conduct of clinical trials of medicinal products in Ukraine: current challenges and ways to overcome them
- Ihor Ivashchenko
- MoH, Kyiv, Ukraine
2. Ukraine – untapped potential
- Iryna Mahdyk
- European Business Association, Kyiv, Ukraine
3. Clinical trials today – treatment standards of the future
- Tetiana Dumenko
- State Expert Center of the MoH, Kyiv, Ukraine
4. Welcome address to participants
- Isaak Trakhtenberg
- academician of the NAMS of Ukraine, corresponding member of the NAS of Ukraine, Kyiv, Ukraine
Section 1. Part I. Regulatory framework for conducting clinical trials: relevance of changes in Ukraine and worldwide
- Moderator:
- Liudmyla Kovtun
PDF1. Regulatory framework for conducting clinical trials: current challenges and ways to overcome themLiudmyla Kovtun, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 1.5 MB · 22.10.2026
PDF2. Clinical research in pediatrics: present and prospectsSerhii Zinchenko, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 2 MB · 22.10.2026
PDF3. Intellectual property objects in clinical trials of medicinal productsOksana Kashyntseva, Olena Ponomarova, Research Institute of Intellectual Property of the National Academy of Legal Sciences of Ukraine, Kyiv, UkrainePDF · 711 KB · 22.10.2026
Section 1. Part II. Regulatory framework for conducting clinical trials: relevance of changes in Ukraine and worldwide
- Moderator:
- Yurii Shemetylo
PDF1. Features of the organization and conduct of preliminary expert evaluation of clinical trial materialsOlha Silantieva, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 1.3 MB · 22.10.2026
PDF2. Improving the stages of expert evaluation of clinical trial materials for medicinal products: specialized expert evaluationOlha Smoliar, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 600 KB · 22.10.2026
PDF3. Current requirements for the investigational medicinal product dossier (pharmaceutical part)Nataliia Donchenko, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 1.1 MB · 22.10.2026
PDF4. Organization of the work of consultative and expert groups in present-day conditionsNataliia Taranenko, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 591 KB · 22.10.2026
Section 2. Latest approaches to the organization and conduct of bioequivalence clinical trials
- Moderator:
- Nadiia Zhukova
PDF1. Topical issues: similarities and differences between the concepts of "genericity", "bioequivalence", "interchangeability"Nadiia Zhukova, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 1.2 MB · 22.10.2026
PDF2. Specifics of proving the proportionality of combinations of two or three active substancesOksana Nahorniak, State Expert Center of the Ministry of Health, Kyiv, Ukraine OnlinePDF · 779 KB · 22.10.2026
PDF3. Pharmacogenetic aspects and bioequivalenceViktor Chumak, Association of Employers’ Organizations of the Medical and Microbiological Industry of Ukraine, Kyiv, UkrainePDF · 1.6 MB · 22.10.2026
Section 3. Use of e-resources in clinical trials of medicinal products
- Moderator:
- Volodymyr Anisimov
PDF1. Electronic application format and visualization as an important resource for access to monitoring the progress of expert evaluation of clinical trial materialsRoman Yurkovych, State Expert Center of the MoH, Kyiv, UkrainePDF · 1.2 MB · 22.10.2026
PDF2. Electronic systems in clinical trials. Evident achievements of digital technologies and first outlines of future victoriesYurii Lebid, LLC Pharmaxi, Kyiv, UkrainePDF · 2.6 MB · 22.10.2026
PDF3. Use of e-resources in clinical trials of medicinal productsVolodymyr Anisimov, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 1 MB · 22.10.2026
Section 4. Legal aspects of organizing and conducting clinical trials in Ukraine and prospects for their improvement
- Moderator:
- Lana Sinichkina
PDF1. Legal aspects of changes in clinical trial regulation: new opportunities and challengesLana Sinichkina, Volodymyr Svintsitskyi, Arzinger Law Firm, Kyiv, UkrainePDF · 765 KB · 22.10.2026
PDF2. Tax disputes and criminal proceedings in clinical trials: recent trends and a case studyKateryna Hupalo, Arzinger Law Firm, Kyiv, UkrainePDF · 985 KB · 22.10.2026
PDF3. Specifics of contractual relations in clinical researchAndrii Horbatenko, Illia Kostin, Legal Alliance law firm, Kyiv, UkrainePDF · 372 KB · 22.10.2026
Section 5. Modern technologies and designs of clinical trials
- Moderator:
- Liudmyla Kovtun
PDF1. New designs of early-phase clinical trials – challenges and future perspectivesAngela Bischoff, ARENSIA GmbH, Düsseldorf, Germany OnlinePDF · 837 KB · 22.10.2026
PDF2. Global trends and perspectives on regulatory processes in early-phase clinical trialsYevhen Levenko, LLC “ARENSIA Exploratory Medicine”, Kyiv, UkrainePDF · 9.1 MB · 22.10.2026
3. Innovative Clinical Trial execution-elements in use&under development in Bayer Clinical Trials (incl. Lessons learned from pandemic situation)
Dr. Klaus-Gustav Beinhauer, Germany On-line
9 OCTOBER 2020
Section 6. Problematic issues in organizing and conducting clinical trials of medicinal products at healthcare facilities
- Moderator:
- Ihor Bondarenko
PDF1. Risks, challenges and ways to overcome problems in conducting clinical trials during the pandemicIhor Bondarenko, DSMA, Dnipro, UkrainePDF · 582 KB · 22.10.2026
PDF2. Proper separation of the functions of the healthcare facility and the investigator in clinical trials: difficulties, risks, contractual relationsIvan Vyshnivetskyi, NGO "Ukrainian Association of Clinical Research", Kyiv, UkrainePDF · 3 MB · 22.10.2026
PDF3. Organization of the work of a local ethics committee at a healthcare institution during the pandemicValerii Novoseletskyi, Ethics Committee at Vinnytsia Regional Clinical Hospital, Vinnytsia, Ukraine On-linePDF · 914 KB · 22.10.2026
Session 7. The place of clinical trials in medicinal product development
- Moderator:
- Kostiantyn Kuzmenko
PDF1. Requirements for demonstrating the efficacy and safety of fixed-combination medicinal productsKostiantyn Kuzmenko, State Expert Center of the MoH, Kyiv, UkrainePDF · 585 KB · 22.10.2026
PDF2. Well-established medicinal use of medicinal products: specifics of the evidence baseYuliia Hula, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 473 KB · 22.10.2026
3. Clinical trials as the basis of the package leaflet of a medicinal product
Viktoriia Chernenko, State Expert Center of the MoH, Kyiv, Ukraine
4. The importance of technology transfer for modern pharmaceutical enterprises
Andrii Hoi, JSC “Farmak”, Kyiv, Ukraine
Section 8. Collection and analysis of adverse reactions during clinical trials of medicinal products
- Moderator:
- Yurii Shemetylo
PDF1. Collection of information on adverse reactions during clinical trialsDaria Andrieieva, State Expert Center of the MoH, Kyiv, UkrainePDF · 1.3 MB · 22.10.2026
PDF2. Analysis of information on adverse reactions during clinical trialsYurii Shemetyllo, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 503 KB · 22.10.2026
PDF3. Requirements for providing information on adverse reactions to registered medicinal products during clinical trialsValeriia Vasylieva, Olena Khoromska, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 838 KB · 22.10.2026
Section 9. Vaccines: development requirements and specifics of conducting clinical trials
- Moderator:
- Oksana Sakhniuk
1. Challenges in vaccine development during a global pandemic.
Frederik Wittke, European Clinical Development Unit, MSD Global Clinical Development, Zurich, Switzerland On-line
PDF2. Requirements for preclinical and clinical studies of vaccinesViktoriia Zadorozhna, Olena Maksymenok, L.V. Hromashevskyi Institute of Epidemiology and Infectious Diseases of the NAMS of Ukraine, Kyiv, UkrainePDF · 568 KB · 22.10.2026
PDF3. Types of vaccines and their development. Vaccination as the most effective method of protecting the population against infectious diseasesOksana Sakhniuk, State Expert Center of the Ministry of Health of Ukraine, Kyiv, UkrainePDF · 585 KB · 22.10.2026
PDF4. Guideline on the preclinical and clinical evaluation of vaccinesMykhailo Kozlov, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 389 KB · 22.10.2026
Section 10. Use of clinical trial results of medicinal products for health technology assessment
- Moderator:
- Tetiana Dumenko
PDF1. Directions for implementing HTA in decision-making in the healthcare system in Ukraine: new challenges and opportunitiesOresta Piniazhko, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 1.4 MB · 22.10.2026
2. Adaptive models and HTA
Rabiia Kakhvedzhy, SAFEMed, Kyiv, Ukraine
PDF3. Methodological approaches to assessing the value of treatment in HTAOleksandra Oleshchuk, Oleksandr Topachevskyi, Expert Committee on the Selection and Use of Essential Medicines of the Ministry of Health of Ukraine, Kyiv, UkrainePDF · 2.7 MB · 22.10.2026
PDF4. Clinical effectiveness indicators in cost-effectiveness analysis for health technology assessmentAlona Masheiko, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 1.3 MB · 22.10.2026
Session 11. Organization and conduct of clinical trials during the COVID-19 pandemic (practical experience)
- Moderator:
- Liudmyla Kovtun
PDF1. Results of a clinical study evaluating the efficacy of Biovenum in the complex therapy of patients with pneumonia caused by the coronavirus infection COVID-19 / SARS-CoV-2Andrii Rybakov, LLC "Biopharma Plasma", Kyiv, UkrainePDF · 971 KB · 22.10.2026
PDF2. Experience of conducting bioequivalence clinical trials during the COVID-19 pandemicKateryna Kovalova, Ihor Kuznetsov, LLC "Clinical and Diagnostic Center "Pharmbiotest", Rubizhne, Ukraine On-linePDF · 1.9 MB · 22.10.2026
PDF3. COVID-19 Challenge: Experience of a research center based in a multidisciplinary hospitalOlena Karpenko, MC "Ok! Clinic+", LLC "International Institute of Clinical Research", Kyiv, UkrainePDF · 4.2 MB · 22.10.2026
Section 12. Quality control of clinical trial conduct under quarantine conditions
- Moderator:
- Serhii Rasputniak
PDF1. Development and transformation of clinical trials in the era of COVID-19. “Some people feel the rain. Others just get wet”Serhii Myronenko, Pharmasych, Kyiv, Ukraine; Franco Sciannini, Nubilaria, Novara, Italy; Nataliia Yushchenko, Perfectum Pharmaceutical Services, Prague, Czech Republic; Vadym Bondarchuk, CCR Ltd, Kyiv, Ukraine; Artem Zymnii, NESPAT, Kyiv, Ukraine On-linePDF · 3.9 MB · 22.10.2026
PDF2. Conducting clinical audits of clinical trials under quarantine conditionsSerhii Rasputniak, Yana Maltseva, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 1.1 MB · 22.10.2026
Section 13. From the clinical trial standard to sectoral standards
- Moderator:
- Oresta Piniazhko
PDF1. Formulary System: Challenges and Ways to ImproveYuliia Malyshevska, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 1.9 MB · 22.10.2026
PDF2. Improving methodological approaches to the development of sectoral standardsIryna Romanenko, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 1 MB · 22.10.2026
3. Assessment of the cost-effectiveness of medicinal products during clinical studies: global experience and opportunities for Ukraine
Viktoriia Dobrova, NUPh, Kharkiv, Ukraine
Section 14. Part I. Organization and conduct of clinical trials during the COVID-19 pandemic
- Moderator:
- Roman Fishchuk
PDF1. Challenges in conducting clinical studies in a primary care healthcare facility during the global COVID-19 pandemicRoman Fishchuk, Municipal Non-Profit Enterprise 'Central City Clinical Hospital of Ivano-Frankivsk City Council' Ivano-Frankivsk, UkrainePDF · 1 MB · 22.10.2026
2. Clinical trials during the COVID-19 pandemic: risks and opportunities for researchers
Ihor Zupanets, NUPh, Kharkiv, Ukraine On-line
PDF3. Practical and legal aspects of patient-centric logistics of clinical trialsOleksandr Diehtiarov, Anastasiia Fesenko, LLC “Agency “S.M.O.-Ukraine”, Kyiv, Ukraine On-linePDF · 1.1 MB · 22.10.2026
Section 14. Part II.
Organization and conduct of clinical trials during the COVID-19 pandemic
- Moderator:
- Tetiana Dumenko
PDF1. Operation of the clinical research department during the SARS-CoV-2 (COVID-19) pandemic. Experience of a single centerHryhorii Ursol, PE PVF ‘Acinus’, Kropyvnytskyi, Ukraine On-linePDF · 850 KB · 22.10.2026
PDF2. Experience in organizing and conducting a clinical study involving patients with COVID-19 under strict quarantine restrictions: compliance with GCP requirements, the Declaration of Helsinki on patients' rights, safety of staffYaroslav Zhebelenko, LLC “Biopharma Plasma,” Kyiv, UkrainePDF · 368 KB · 22.10.2026
PDF3. Infection control in clinical trials during the COVID-19 pandemicOleh Yakovenko, Volyn Regional Clinical Hospital, Lutsk, Ukraine OnlinePDF · 1.4 MB · 22.10.2026
PDF4. Challenges in conducting clinical trials during the COVID-19 pandemicOleksandr Torhun, Andrii Doroshenko, PrJSC “FF Darnytsia”, Kyiv, UkrainePDF · 1.5 MB · 22.10.2026
Section 15. Selected issues of preclinical and clinical trials
- Moderator:
- Yurii Bisiuk
PDF1. Assessment of immunogenicity in the use of biosimilarsYurii Bisiuk, P. L. Shupyk National Medical Academy of Postgraduate Education, Kyiv, UkrainePDF · 3 MB · 22.10.2026
PDF2. Experience of using quality management tools in clinical trials of medicinal products for the treatment of autoimmune diseasesIryna Litovchenko,
Medical Clinical Investigational Centre 'Health Clinic', Vinnytsia, UkrainePDF · 749 KB · 22.10.2026
PDF3. The role of preclinical data in deciding on the conduct of clinical trialsOlena Apykhtina, State Institution “Kundiiev Institute of Occupational Health of the National Academy of Medical Sciences of Ukraine”, Kyiv, UkrainePDF · 1.5 MB · 22.10.2026
Section 16. Ethical aspects of conducting clinical trials of medicinal products
- Moderator:
- Liudmyla Kovtun
1. Ethical issues in conducting clinical trials during COVID-19
Kseniia Ratushna, NUPh, Kharkiv, Ukraine On-line
PDF2. Risk assessment during ethical review of clinical trials of medicinal productsLiudmyla Kovtun, State Expert Center of the MoH, Kyiv, UkrainePDF · 920 KB · 22.10.2026
PDF3. Problems and specifics of ethical review of non-interventional clinical studiesLesia Yankova, State Expert Center of the Ministry of Health, Kyiv, UkrainePDF · 689 KB · 22.10.2026
GCP Seminar Part I Online
1. GCP principles and regulatory requirements for conducting clinical trials of medicinal products
Liudmyla Kovtun, State Expert Center of the MoH, Kyiv, Ukraine
GCP Seminar Part II Online
2. Ethical aspects of conducting clinical trials
Olha Smoliar, State Expert Center of the MoH, Kyiv, Ukraine
3. Documents accompanying the clinical trial
Tetiana Dmytrakova, State Expert Center of the MoH, Kyiv, Ukraine
GCP Seminar Part III Online
4. Investigator's responsibilities
Lesia Yankova, State Expert Center of the MoH, Kyiv, Ukraine
GCP Seminar Part IV Online
5. Sponsor's responsibilities
Serhii Rasputniak, State Expert Center of the MoH, Kyiv, Ukraine
6. Clinical audit of a clinical trial
Yana Maltseva, State Expert Center of the MoH, Kyiv, Ukraine
