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
Section 1. Part ІІ: Regulatory framework for clinical trials: current changes in Ukraine and other countries
- Moderator:
- Yurii Shemetyllo
Section 2: Novel approaches to organization and conduct of bioequivalence clinical trials
- Moderator:
- Nadiia Zhukova
Section 3: Using e-resources in clinical trials of medicinal products
- Moderator:
- Volodymyr Anisimov
Section 4: Legal aspects of organization and conduct of clinical trials in Ukraine and prospects for improving them
- Moderator:
- Lana Sinichkina
Section 5: Current methods and designs of clinical trials
- Moderator:
- Liudmyla Kovtun
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
Section 7: Role of clinical trials in drug development
- Moderator:
- Kostiantyn Kuzmenko
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
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
Section 10: Use of results of clinical trials of medicinal products for health technology assessment
- Moderator:
- Tetyana Dumenko
2. Oresta Piniazhko, the State Expert Center MoH, Kyiv, Ukraine
Rabia Kahveci, SAFEMed, Kyiv, Ukraine
Section 11: Organization and conduct of CTs during the COVID-19 pandemic (practical experience)
- Moderator:
- Liudmyla Kovtun
Section 12: Quality control of clinical trials under the conditions of quarantine
- Moderator:
- Sergii Rasputniak
Section 13: From a standard for conducting CT to industry standards
- Moderator:
- Oresta Piniazhko
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
2. Clinical trials during the COVID-19: risks and opportunities for investigators
Ihor Zupanets, the National University of Pharmacy, Kharkiv, Ukraine On-line
Section 14. Part II Organization and conduct of clinical trials during the COVID-19 pandemic
- Moderator:
- Tetyana Dumenko
Section 15 Some issues of preclinical and clinical trials
- Moderator:
- Yurii Bisiuk
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
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
