PRESENTATIONS OF THE SIXTH SCIENTIFIC-PRACTICAL CONFERENCE WITH INTERNATIONAL PARTICIPATION «CLINICAL TRIALS OF MEDICINAL PRODUCTS IN UKRAINE: NEW CHALLENGES AND RESPONSES TO THEM» OCTOBER 8-9, 2020
PRESENTATIONS
of the sixth scientific-practical conference with international participation
«CLINICAL TRIALS OF MEDICINAL PRODUCTS IN UKRAINE: NEW CHALLENGES AND RESPONSES TO THEM»
October 8-9, 2020
OCTOBER 8, 2020
Official opening of the conference
- Vitaliy Tsymbaliuk
- Member of NAMS Ukraine, Corresponding Member of NAS Ukraine, president of NAMS Ukraine, Kyiv, Ukraine
- Ihor Ivashchenko
- Deputy Minister of Health of Ukraine for European Integration, Kyiv, Ukraine
- Tetyana Dumenko
- Director of the State Expert Center MoH, Kyiv, Ukraine
- Serhiy Mykhaylov
- clinical research director «MSD Ukraine» LLC, Kyiv, Ukraine
-
Plenary session
1. Prospects for improving clinical trials of medicinal products in Ukraine: current challenges and ways to overcome them (474.9 Кб) (Завантажено: 25.01.2021 08:44:02)- Ihor Ivashchenko
- MoH Ukraine, Kyiv, Ukraine
2. Ukraine – unused potential
- Irina Magdik
- European Business Association, Kyiv, Ukraine
- 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
1. Legal basis for clinical trials: current challenges and ways to overcome them
Liudmyla Kovtun, the State Expert Center MoH, Kyiv, Ukraine
2. Pediatric clinical trials: current status and prospects
Serhii Zinchenko, the State Expert Center MoH, Kyiv, Ukraine
3. Intellectual property objects in clinical trials of medicinal products
Oksana Kashyntseva, Olena Ponomariova, the Scientific Research Institute of Intellectual Property of the National Academy of Law Sciences (NALS) of Ukraine, Kyiv, Ukraine
Section 1. Part ІІ: Regulatory framework for clinical trials: current changes in Ukraine and other countries
- Moderator:
- Yurii Shemetyllo
1. Peculiarities of organization and conduct of preliminary expert evaluation of clinical trial materials
Olha Silantieva, the State Expert Center MoH, Kyiv, Ukraine
2. Improving stages of expert evaluation of materials pertinent to CTs of medicinal products: specialized examination of CT materials
Olga Smoliar, the State Expert Center MoH, Kyiv, Ukraine
3. Current requirements for Investigational Medicinal Product Dossier (pharmaceutical part)
Nataliia Donchenko, the State Expert Center MoH, Kyiv, Ukraine
4. Organization of Advisory Expert Unit work at the present time
Nataliia Taranenko, the State Expert Center MoH, Kyiv, Ukraine
Section 2: Novel approaches to organization and conduct of bioequivalence clinical trials
- Moderator:
- Nadiia Zhukova
1. Current issues: similarity and difference between the concepts of “genericity”, “bioequivalence”, “interchangeability”
Nadiia Zhukova, the State Expert Center MoH, Kyiv, Ukraine
2. Peculiarities of proving proportionality of combinations of two or three active substances
Oksana Nahorniak, the State Expert Center MoH, Kyiv, Ukraine
3. Pharmacogenetic aspects and bioequivalence
Viktor Chumak, the Ukrainian Association of Organisations for Medical and Microbiological Employers, Kyiv, Ukraine
Section 3: Using e-resources in clinical trials of medicinal products
- Moderator:
- Volodymyr Anisimov
1. E-application and visualization as an important instrument to control the process of expert evaluation of CT materials
Roman Yurkovych, the State Expert Center MoH, Kyiv, Ukraine
2. Electronic systems in clinical trials. Obvious achievements of digital technologies and the first outlines of future victories
Yuriу Lebed, Pharmaxi LLC, Kyiv, Ukraine
3. The use of e-resources in clinical trials
Volodymyr Anisimov, the State Expert Center MoH, Kyiv, Ukraine
Section 4: Legal aspects of organization and conduct of clinical trials in Ukraine and prospects for improving them
- Moderator:
- Lana Sinichkina
1. Legal aspects of changes in clinical trial regulation: new opportunities and challenges
Lana Sinichkina, Volodymyr Svintsitskyi, Arzinger law firm, Kyiv, Ukraine
2. Tax disputes and criminal proceedings in CT: recent trends and case study
Kateryna Gupalo, “Arzinger law firm”, Kyiv, Ukraine
3. Peculiarities of contractual relationship in clinical trials
Andrii Horbatenko, Illia Kostin, Legal Alliance Company, Kyiv, Ukraine
Section 5: Current methods and designs of clinical trials
- Moderator:
- Liudmyla Kovtun
1. New trial designs for early drug development – Challenges and future visions
Angela Bischoff, ARENSIA GmbH, Düsseldorf, Germany On-line
2. Global trends and views on regulatory processes in early clinical trials
Evgeny Levenko, ARENSIA Exploratory Medicine GmbH, Kyiv, Ukraine
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
1. Risks, challenges and ways to overcome problems of conduct of clinical trials during a pandemic
Ihor Bondarenko, the Dnipropetrovsk State Medical Academy, Dnipro, Ukraine
2. Proper separation of functions of a HCS and an investigator in CTs: difficulties, risks, contractual relations
Ivan Vyshnyvetskyi, NGO “The Ukrainian Association of Clinical Research”, Kyiv, Ukraine
3. Provision of the operation of local ethics committee at HCS during a pandemic
Valerii Novoseletskyi, the Ethics Committee at M.I. Pyrihiv Vinnytsa Oblast Clinical Hospital, Vinnytsia, Ukraine On-line
Section 7: Role of clinical trials in drug development
- Moderator:
- Kostiantyn Kuzmenko
1. Requirements to establish efficacy and safety of medicinal products with fixed dose combination
Kostiantyn Kuzmenko, the State Expert Center MoH, Kyiv, Ukraine
2. Well-established medical use of MPs: peculiarities of evidentiary basis
Yuliya Gula, the State Expert Center MoH, Kyiv, Ukraine
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
1. Collection of ADR information in clinical trials
Dariia Andrieieva, the State Expert Center MoH, Kyiv, Ukraine
2. Analysis of ADR information in clinical trials
Yurii Shemetyllo, the State Expert Center MoH, Kyiv, Ukraine
3. Requirements for reporting ADR to unregistered medicinal products in clinical trials
Valeriia Vasylieva, Olena Khoromska, the State Expert Center MoH, Kyiv, Ukraine
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
2. Requirements for preclinical and clinical studies of vaccines
Viktoriia Zadorozhna, Olena Maksymenok, L.V. Hromashevskyi Institute of Epidemiology and Infectious Diseases NAMSU, Kyiv, Ukraine
3. Vaccines types and their development. Vaccination as the most effective method of protection of the population from infectious diseases
Oksana Sakhniuk, the State Expert Center MoH, Kyiv, Ukraine
4. Guideline on preclinical and clinical assessment of vaccines
Mykhailo Kozlov, the State Expert Center MoH, Kyiv, Ukraine
Section 10: Use of results of clinical trials of medicinal products for health technology assessment
- Moderator:
- Tetyana Dumenko
1. Directions of HTA implementation in health care decision-making in Ukraine: new challenges and possibilities
Oresta Piniazhko, the State Expert Center MoH, Kyiv, Ukraine
2. Oresta Piniazhko, the State Expert Center MoH, Kyiv, Ukraine
Rabia Kahveci, SAFEMed, Kyiv, Ukraine
3. Methodological approaches to assessing treatment value in HTA
Oleksandra Oleshchuk, Oleksandr Topochevskyi, Expert Committee on Selection and Use of Essential Medicines, Kyiv, Ukraine
4. Indicators of medicinal product clinical efficacy in pharmacoeconomic analysis
Aliona Masheiko, the State Expert Center MoH, Kyiv, Ukraine
Section 11: Organization and conduct of CTs during the COVID-19 pandemic (practical experience)
- Moderator:
- Liudmyla Kovtun
Andrii Rybakov, “Biopharma Plasma” LLC, Kyiv, Ukraine
2. Experience in conducting clinical trials for establishing bioequivalence during the COVID-19 pandemic
Kateryna Kovaliova, Ihor Kuznetsov, Clinical Diagnostics Center «Pharmbiotest» LLC, Rubizhne, Ukraine On-line
3. COVID-19 Challenges: Experience of work of research center at multi-field hospital
Olena Karpenko, Medical Center ‘Ok!Clinic+’ of International Institute of Clinical Studies LLC, Kyiv, Ukraine
Section 12: Quality control of clinical trials under the conditions of quarantine
- Moderator:
- Sergii Rasputniak
1. 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-line
2. Clinical audit of clinical trials in quarantine
Sergii Rasputniak, Iana Maltseva, the State Expert Center MoH, Kyiv, Ukraine
Section 13: From a standard for conducting CT to industry standards
- Moderator:
- Oresta Piniazhko
1. Formulary system: challenges and ways for improving it
Yuliia Malyshevska, the State Expert Center MoH, Kyiv, Ukraine
2. Yuliia Malyshevska, the State Expert Center MoH, Kyiv, Ukraine
Iryna Romanenko, the State Expert Center MoH, Kyiv, Ukraine
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
1. Challenges for the conduct of clinical trials in primary health care facilities during the COVID-19 pandemic
Roman Fishchuk, MNE “The Central City Clinical Hospital of the Ivano-Frankivsk City Council”, Ivano-Frankivsk, Ukraine
2. Clinical trials during the COVID-19: risks and opportunities for investigators
Ihor Zupanets, the National University of Pharmacy, Kharkiv, Ukraine On-line
3. Practical and legal aspects of patient-centered logistics of clinical trials
Oleksandr Dehtiarov, Anastasis Fesenko, “SMO-Ukraine Agency” LLC, Kyiv, Ukraine On-line
Section 14. Part II Organization and conduct of clinical trials during the COVID-19 pandemic
- Moderator:
- Tetyana Dumenko
1. Work of Clinical Trials Department during the the SARS-CoV-2 (COVID-19) pandemic. Experience of a research site
Grygoryi Ursol, PE PPF “ACINUS”, Kropyvnytskyi, Ukraine On-line
2. 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 performers
Yaroslav Zhebelenko, “Biopharma Plasma” LLC, Kyiv, Ukraine
3. Infection control in clinical trials during the COVID-19 pandemic
Oleh Yakovenko, the Volyn Regional Clinical Hospital, Lutsk, Ukraine On-line
4. Challenges for the conduct of clinical trials during the COVID-19 pandemic
Oleksandr Torhun, Andrii Doroshenko, PRJSC “PF Darnitsa”, Kyiv, Ukraine
Section 15 Some issues of preclinical and clinical trials
- Moderator:
- Yurii Bisiuk
1. Immunogenicity assessment of biosimilars
Yurii Bisiuk, P.L. Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine
2. Experience in using quality management tools in CTs of MPs for autoimmune diseases
3. Role of preclinical data for CT decision making
Olena Apykhtina, SI “Kundiiev Institute of Occupational Health NAMS Ukraine” Kyiv, Ukraine
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
2. Risk assessment at ethical review of clinical trials of medicinal products
Liudmyla Kovtun, the State Expert Center MoH, Kyiv, Ukraine
3. Ethical aspects of interventional and non-interventional studies
Lesia Iankova, the State Expert Center MoH, Kyiv, Ukraine
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
