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
3. Today’s clinical trials are treatment standards in the future (2.7 MБ) (Завантажено: 25.01.2021 08:44:02)
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