Plenary session
1. Prospects for improving clinical trials of medicinal products in Ukraine: current challenges and ways to overcome them
- Ihor Ivashchenko
- MoH Ukraine, Kyiv, Ukraine
2. Ukraine – unused potential
- Irina Magdik
- European Business Association, Kyiv, Ukraine
3. Today’s clinical trials are treatment standards in the future
- Tetyana Dumenko
- the State Expert Center MoH, Kyiv, Ukraine
4. the State Expert Center MoH, Kyiv, Ukraine
- Isaak Mykhailovych Trakhtenberh
- Corresponding Member of NAS Ukraine, Member of NAMS Ukraine, Kyiv, Ukraine
Section 1. Part І: Regulatory framework for clinical trials: current changes in Ukraine and other countries
- Moderator:
- Liudmyla Kovtun
PDF1. Legal basis for clinical trials: current challenges and ways to overcome themLiudmyla Kovtun, the State Expert Center MoH, Kyiv, UkrainePDF · 1.5 МБ · 25.01.2021
PDF2. Pediatric clinical trials: current status and prospectsSerhii Zinchenko, the State Expert Center MoH, Kyiv, UkrainePDF · 2 МБ · 25.01.2021
PDF3. Intellectual property objects in clinical trials of medicinal productsOksana Kashyntseva, Olena Ponomariova, the Scientific Research Institute of Intellectual Property of the National Academy of Law Sciences (NALS) of Ukraine, Kyiv, UkrainePDF · 711 КБ · 25.01.2021
Section 1. Part ІІ: Regulatory framework for clinical trials: current changes in Ukraine and other countries
- Moderator:
- Yurii Shemetyllo
PDF1. Peculiarities of organization and conduct of preliminary expert evaluation of clinical trial materialsOlha Silantieva, the State Expert Center MoH, Kyiv, UkrainePDF · 1.3 МБ · 25.01.2021
PDF2. Improving stages of expert evaluation of materials pertinent to CTs of medicinal products: specialized examination of CT materialsOlga Smoliar, the State Expert Center MoH, Kyiv, UkrainePDF · 600 КБ · 25.01.2021
PDF3. Current requirements for Investigational Medicinal Product Dossier (pharmaceutical part)Nataliia Donchenko, the State Expert Center MoH, Kyiv, UkrainePDF · 1.1 МБ · 25.01.2021
PDF4. Organization of Advisory Expert Unit work at the present timeNataliia Taranenko, the State Expert Center MoH, Kyiv, UkrainePDF · 591 КБ · 25.01.2021
Section 2: Novel approaches to organization and conduct of bioequivalence clinical trials
- Moderator:
- Nadiia Zhukova
PDF1. Current issues: similarity and difference between the concepts of “genericity”, “bioequivalence”, “interchangeability”Nadiia Zhukova, the State Expert Center MoH, Kyiv, UkrainePDF · 1.2 МБ · 25.01.2021
PDF2. Peculiarities of proving proportionality of combinations of two or three active substancesOksana Nahorniak, the State Expert Center MoH, Kyiv, UkrainePDF · 779 КБ · 25.01.2021
PDF3. Pharmacogenetic aspects and bioequivalenceViktor Chumak, the Ukrainian Association of Organisations for Medical and Microbiological Employers, Kyiv, UkrainePDF · 1.6 МБ · 25.01.2021
Section 3: Using e-resources in clinical trials of medicinal products
- Moderator:
- Volodymyr Anisimov
PDF1. E-application and visualization as an important instrument to control the process of expert evaluation of CT materialsRoman Yurkovych, the State Expert Center MoH, Kyiv, UkrainePDF · 1.2 МБ · 25.01.2021
PDF2. Electronic systems in clinical trials. Obvious achievements of digital technologies and the first outlines of future victoriesYuriу Lebed, Pharmaxi LLC, Kyiv, UkrainePDF · 2.6 МБ · 25.01.2021
PDF3. The use of e-resources in clinical trialsVolodymyr Anisimov, the State Expert Center MoH, Kyiv, UkrainePDF · 1 МБ · 25.01.2021
Section 4: Legal aspects of organization and conduct of clinical trials in Ukraine and prospects for improving them
- 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 КБ · 25.01.2021
PDF2. Tax disputes and criminal proceedings in CT: recent trends and case studyKateryna Gupalo, “Arzinger law firm”, Kyiv, UkrainePDF · 985 КБ · 25.01.2021
PDF3. Peculiarities of contractual relationship in clinical trialsAndrii Horbatenko, Illia Kostin, Legal Alliance Company, Kyiv, UkrainePDF · 372 КБ · 25.01.2021
Section 5: Current methods and designs of clinical trials
- Moderator:
- Liudmyla Kovtun
PDF1. New trial designs for early drug development – Challenges and future visionsAngela Bischoff, ARENSIA GmbH, Düsseldorf, Germany On-linePDF · 837 КБ · 25.01.2021
PDF2. Global trends and views on regulatory processes in early clinical trialsEvgeny Levenko, ARENSIA Exploratory Medicine GmbH, Kyiv, UkrainePDF · 9.1 МБ · 25.01.2021
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
OCTOBER 9, 2020
Section 6: Contentious issues of organization and conduct of clinical trials of medicinal products at HCS
- Moderator:
- Ihor Bondarenko
PDF1. Risks, challenges and ways to overcome problems of conduct of clinical trials during a pandemicIhor Bondarenko, the Dnipropetrovsk State Medical Academy, Dnipro, UkrainePDF · 582 КБ · 25.01.2021
PDF2. Proper separation of functions of a HCS and an investigator in CTs: difficulties, risks, contractual relationsIvan Vyshnyvetskyi, NGO “The Ukrainian Association of Clinical Research”, Kyiv, UkrainePDF · 3 МБ · 25.01.2021
PDF3. Provision of the operation of local ethics committee at HCS during a pandemicValerii Novoseletskyi, the Ethics Committee at M.I. Pyrihiv Vinnytsa Oblast Clinical Hospital, Vinnytsia, Ukraine On-linePDF · 914 КБ · 25.01.2021
Section 7: Role of clinical trials in drug development
- Moderator:
- Kostiantyn Kuzmenko
PDF1. Requirements to establish efficacy and safety of medicinal products with fixed dose combinationKostiantyn Kuzmenko, the State Expert Center MoH, Kyiv, UkrainePDF · 585 КБ · 25.01.2021
PDF2. Well-established medical use of MPs: peculiarities of evidentiary basisYuliya Gula, the State Expert Center MoH, Kyiv, UkrainePDF · 473 КБ · 25.01.2021
3. CT as the basis for instructions for medical use of MPs
Viktoriia Chernenko, the State Expert Center MoH, Kyiv, Ukraine
4. Importance of technology transfer for modern pharmaceutical enterprises
Andriy Goy, JSC “Farmak”, Kyiv, Ukraine
Section 8: ADR collection and analysis in clinical trials of medicinal products
- Moderator:
- Yurii Shemetyllo
PDF1. Collection of ADR information in clinical trialsDariia Andrieieva, the State Expert Center MoH, Kyiv, UkrainePDF · 1.3 МБ · 25.01.2021
PDF2. Analysis of ADR information in clinical trialsYurii Shemetyllo, the State Expert Center MoH, Kyiv, UkrainePDF · 503 КБ · 25.01.2021
PDF3. Requirements for reporting ADR to unregistered medicinal products in clinical trialsValeriia Vasylieva, Olena Khoromska, the State Expert Center MoH, Kyiv, UkrainePDF · 838 КБ · 25.01.2021
Section 9 Vaccines: development requirements and peculiarities of clinical trials
- Moderator:
- Oksana Sakhniuk
1. Challenges of vaccine development during a global pandemic
Frederick Wittke, MSD, 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 NAMSU, Kyiv, UkrainePDF · 568 КБ · 25.01.2021
PDF3. Vaccines types and their development. Vaccination as the most effective method of protection of the population from infectious diseasesOksana Sakhniuk, the State Expert Center MoH, Kyiv, UkrainePDF · 585 КБ · 25.01.2021
PDF4. Guideline on preclinical and clinical assessment of vaccinesMykhailo Kozlov, the State Expert Center MoH, Kyiv, UkrainePDF · 389 КБ · 25.01.2021
Section 10: Use of results of clinical trials of medicinal products for health technology assessment
- Moderator:
- Tetyana Dumenko
PDF1. Directions of HTA implementation in health care decision-making in Ukraine: new challenges and possibilitiesOresta Piniazhko, the State Expert Center MoH, Kyiv, UkrainePDF · 1.4 МБ · 25.01.2021
2. Oresta Piniazhko, the State Expert Center MoH, Kyiv, Ukraine
Rabia Kahveci, SAFEMed, Kyiv, Ukraine
PDF3. Methodological approaches to assessing treatment value in HTAOleksandra Oleshchuk, Oleksandr Topochevskyi, Expert Committee on Selection and Use of Essential Medicines, Kyiv, UkrainePDF · 2.7 МБ · 25.01.2021
PDF4. Indicators of medicinal product clinical efficacy in pharmacoeconomic analysisAliona Masheiko, the State Expert Center MoH, Kyiv, UkrainePDF · 1.3 МБ · 25.01.2021
Section 11: Organization and conduct of CTs during the COVID-19 pandemic (practical experience)
- Moderator:
- Liudmyla Kovtun
PDFФайл 1 з 50Andrii Rybakov, “Biopharma Plasma” LLC, Kyiv, UkrainePDF · 971 КБ · 25.01.2021
PDF2. Experience in conducting clinical trials for establishing bioequivalence during the COVID-19 pandemicKateryna Kovaliova, Ihor Kuznetsov, Clinical Diagnostics Center «Pharmbiotest» LLC, Rubizhne, Ukraine On-linePDF · 1.9 МБ · 25.01.2021
PDF3. COVID-19 Challenges: Experience of work of research center at multi-field hospitalOlena Karpenko, Medical Center ‘Ok!Clinic+’ of International Institute of Clinical Studies LLC, Kyiv, UkrainePDF · 4.2 МБ · 25.01.2021
Section 12: Quality control of clinical trials under the conditions of quarantine
- Moderator:
- Sergii Rasputniak
PDF1. Development and transformation of clinical trials in the era of Covid-19 “Some people feel the rain. Others just get wet.”Sergii Myronenko, PharmaSich, LLC, Kyiv, Ukraine; Franco Sciannini, Nubilaria, Novara, Italy; Nataliia Yushchenko, Perfectum Pharmaceuticals Services, Prague, the Czech Republic; Valym Bondarchuk, CCR Ltd, Kyiv, Ukraine; Artem Zymniy, NeSPaT, Kyiv, Ukraine On-linePDF · 3.9 МБ · 25.01.2021
PDF2. Clinical audit of clinical trials in quarantineSergii Rasputniak, Iana Maltseva, the State Expert Center MoH, Kyiv, UkrainePDF · 1.1 МБ · 25.01.2021
Section 13: From a standard for conducting CT to industry standards
- Moderator:
- Oresta Piniazhko
PDF1. Formulary system: challenges and ways for improving itYuliia Malyshevska, the State Expert Center MoH, Kyiv, UkrainePDF · 1.9 МБ · 25.01.2021
PDF2. Yuliia Malyshevska, the State Expert Center MoH, Kyiv, UkraineIryna Romanenko, the State Expert Center MoH, Kyiv, UkrainePDF · 1 МБ · 25.01.2021
3. Evaluation of cost-effectiveness of MPs during clinical trials: global experience and opportunities for Ukraine
Viktoriia Dobrova, National University of Pharmacy, Kharkiv, Ukraine
Section 14: Part I Organization and conduct of CTs during the COVID-19 pandemic
- Moderator:
- Roman Fishchuk
PDF1. Challenges for the conduct of clinical trials in primary health care facilities during the COVID-19 pandemicRoman Fishchuk, MNE “The Central City Clinical Hospital of the Ivano-Frankivsk City Council”, Ivano-Frankivsk, UkrainePDF · 1 МБ · 25.01.2021
2. Clinical trials during the COVID-19: risks and opportunities for investigators
Ihor Zupanets, the National University of Pharmacy, Kharkiv, Ukraine On-line
PDF3. Practical and legal aspects of patient-centered logistics of clinical trialsOleksandr Dehtiarov, Anastasis Fesenko, “SMO-Ukraine Agency” LLC, Kyiv, Ukraine On-linePDF · 1.1 МБ · 25.01.2021
Section 14. Part II Organization and conduct of clinical trials during the COVID-19 pandemic
- Moderator:
- Tetyana Dumenko
PDF1. Work of Clinical Trials Department during the the SARS-CoV-2 (COVID-19) pandemic. Experience of a research siteGrygoryi Ursol, PE PPF “ACINUS”, Kropyvnytskyi, Ukraine On-linePDF · 850 КБ · 25.01.2021
PDF2. Experience in the organization and conduct of a clinical trial with COVID-19 patients under severe quarantine restrictions in compliance with GCP requirements, the Declaration of Helsinki on rights of patients, safety of performersYaroslav Zhebelenko, “Biopharma Plasma” LLC, Kyiv, UkrainePDF · 368 КБ · 25.01.2021
PDF3. Infection control in clinical trials during the COVID-19 pandemicOleh Yakovenko, the Volyn Regional Clinical Hospital, Lutsk, Ukraine On-linePDF · 1.4 МБ · 25.01.2021
PDF4. Challenges for the conduct of clinical trials during the COVID-19 pandemicOleksandr Torhun, Andrii Doroshenko, PRJSC “PF Darnitsa”, Kyiv, UkrainePDF · 1.5 МБ · 25.01.2021
Section 15 Some issues of preclinical and clinical trials
- Moderator:
- Yurii Bisiuk
PDF1. Immunogenicity assessment of biosimilarsYurii Bisiuk, P.L. Shupyk National Medical Academy of Postgraduate Education, Kyiv, UkrainePDF · 3 МБ · 25.01.2021
PDF2. Experience in using quality management tools in CTs of MPs for autoimmune diseasesPDF · 749 КБ · 25.01.2021
PDF3. Role of preclinical data for CT decision makingOlena Apykhtina, SI “Kundiiev Institute of Occupational Health NAMS Ukraine” Kyiv, UkrainePDF · 1.5 МБ · 25.01.2021
Section 16 Ethical aspects of clinical trials of medicinal products
- Moderator:
- Liudmyla Kovtun
1. Ethical issues in CTs under the COVID-19
Kseniia Ratushna, the National University of Pharmacy, Kharkiv, Ukraine
PDF2. Risk assessment at ethical review of clinical trials of medicinal productsLiudmyla Kovtun, the State Expert Center MoH, Kyiv, UkrainePDF · 920 КБ · 25.01.2021
PDF3. Ethical aspects of interventional and non-interventional studiesLesia Iankova, the State Expert Center MoH, Kyiv, UkrainePDF · 689 КБ · 25.01.2021
GCP Workshop Part І On-line
1. GCP principles and regulatory requirements in clinical trials of medicinal products
Liudmyla Kovtun, the State Expert Center MoH, Kyiv, Ukraine
GCP Workshop Part ІІ On-line
2. Ethical aspects of clinical trials
Olha Smoliar, the State Expert Center MoH, Kyiv, Ukraine
3. Documents for the conduct of a clinical trial
Tetiana Dmytrakova, the State Expert Center MoH, Kyiv, Ukraine
GCP Workshop Part ІІІ On-line
4. Investigator responsibilities
Lesia Iankova, the State Expert Center MoH, Kyiv, Ukraine
GCP Workshop Part ІV On-line
5. Sponsor responsibilities
Sergii Rasputniak, the State Expert Center MoH, Kyiv, Ukraine
6. Clinical audit of CTs
Iana Maltseva, the State Expert Center MoH, Kyiv, Ukraine
