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PHARM EXPERT

2023

The establishment of a single National Regulatory Authority (NRA) is an important reform.

The NRA aims to streamline the processes of the development and production of medicinal products, as well as to ensure effective control of the quality, safety, and effectiveness of medicinal products.

At this forum, we will discuss the advantages of creating the NRA, the challenges that need to be overcome, and the role of various stakeholders in the establishment and operation of the NRA.

The event will provide an excellent opportunity for all interested parties to exchange ideas and contribute to the future of the pharmaceutical industry in Ukraine.

Who should attend

PharmExpert 2023

#1
 Pharmaceutical companies
#2
 Distributors and retailers
#3
 Clinical trial stakeholders
#4
 Professional associations and organizations
#5
 Academic and scientific society
#6
 Healthcare professionals

Why should you attend our event?

#1
 Every attendee will have the opportunity to participate in discussions on critical matters related to the establishment of the NRA.
#2
 Conference participants can share their expertise and knowledge.
#3
 The forum's outcome will be the development of a consensus on the creation of a single NRA and the adoption of a resolution based on the event's results.

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Program of the event

PHARMEXPERT

2023

Block 1.

International experience and best European regulatory practices.

Moderator: Yevhen Kunda, CEO Proxima Research International.

09:30-09:40 (GMT +3)

Opening remarks and video: Ukrainian pharmaceutical industry with focus on the patient.

Yevhen Kunda

CEO Proxima Research International

Yevhen Kunda
09:40-09:50 (GMT +3)

Welcome and introduction.

Krzysztof Łanda

Doctor, adviser to the Minister of Health of Ukraine, ex-deputy Minister of Health of Poland

09:50-09:55 (GMT +3)

Welcome and introduction.

Emer Cooke

Executive Director of the European Medicines Agency (EMA) (video message).

Emer Cooke
09:55-10:10 (GMT +3)

European approaches to the functioning of regulatory authorities: experience of Sweden.

Björn Eriksson

Director General of the Swedish Medical Products Agency (online)

Björn Eriksson
10:10-10:25 (GMT +3)

European approaches to the functioning of regulatory authorities: experience of Croatia.

Rajka Truban Žulj

Deputy Head for Operation of the Agency for Medicinal Products and Medical Devices of Croatia (online).

Rajka Truban Žulj
10:25-10:40 (GMT +3)

European approaches to the functioning of regulatory authorities: experience of Poland.

Grzegorz Cessak

President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the Republic of Poland (online)

Grzegorz Cessak
10:40-10:55 (GMT +3)

European approaches to the functioning of regulatory authorities: experience of Poland.

Vincent Gazin

Deputy Director for Europe and Innovation, National Agency for the Safety of Medicines and Health Products of France (ANSM)

10:55-11:10 (GMT +3)

European approaches to the functioning of regulatory authorities: experience of Ireland.

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority (HPRA), Ireland (online)

Lorraine Nolan
11:10-11:30 (GMT +3)

Technical support for the implementation of advanced approaches in the pharmaceutical industry of Ukraine.

Rebecca Ann Kohler

Project Director, SAFEMed, USAID (online)

Rebecca Ann Kohler

Serhiy Strashuk

Deputy Project Director, SAFEMed, USAID

Serhiy Strashuk
11:30-11:45 (GMT +3)

Establishment of NRA in Ukraine - EU industry's perspective.

Adrian van den Hoven

Director General, Medicines for Europe (online)

Adrian van den Hoven
Coffee break
11:45-12:15

Coffee break

Block 2.

Practical issues of establishment of single NRA.

Moderator: Yevhen Kunda, CEO Proxima Research International

12:15-12:30 (GMT +3)

Expectations and plans: a roadmap for establishment of NRA.

Maryna Slobodnichenko

Deputy Minister of Health of Ukraine for European Integration

Maryna Slobodnichenko
12:30-12:45 (GMT +3)

The role and readiness of the State Service of Ukraine on Medicines and Drugs Control for the establishment and operation of NRA, as well as ensuring the quality of medicinal products.

Roman Isaienko

Head of the State Service of Ukraine on Medicines and Drugs Control

Roman Isaienko
12:45-13:00 (GMT +3)

Opinion on transfer of functions of the State Expert Center of the Ministry of Health of Ukraine to NRA.

Mykhaylo Babenko

Director of the State Expert Center of the Ministry of Health of Ukraine

Mykhaylo Babenko
13:00-13:15 (GMT +3)

Changes in work of the MOH due to NRA establishment.

Taras Liaskovskyi

Head of Pharmaceutical Department of the Ministry of Health of Ukraine

Taras Liaskovskyi
Lunch
13:15-14:15 (GMT +3)

Lunch

Block 3.

Opinions of market players regarding the establishment of NRA.

14:15-15:00 (GMT +3)
Panel 1.

Clinical trials: readiness for changes and expectations from the establishment of NRA.

Moderator: Ivan Vyshnyvetskyy, President of the Ukrainian Association for Clinical Resea.

Prospects of new medicines research in new conditions.

Iryna Magdik

Executive Director of the Clinical Trials Subcommittee, European Business Association.

Iryna Magdik

Challenges that sponsors of clinical trials may face in the new environment.

Iryna Andrieieva

Country Trials Manager at Pfizer

Iryna Andrieieva

Challenges that sponsors of clinical trials may face in the new environment.

Vitaliy Solskyy

Director Project Management of Fortrea Development Ukraine, Candidate of Medical Sciences

Vitaliy Solskyy
15:00-16:00 (GMT +3)
Panel 2.

Manufacturers: readiness for changes and expectations from the establishment of NRA.

Moderator: Yevhen Kunda, CEO Proxima Research International.

European integration areas of influence on the structure of drug consumption.

Serhii Ishchenko

СPO Proxima Research International.

Serhii Ishchenko

Readiness of domestic employers’ companies for new requirements.

Representative of NGO

"Association of employers' organizations of the medical and microbiological industry of Ukraine" (AOMMIU)

Readiness of domestic employer companies for new requirements.

Mykhailo Renskyi

Deputy CEO for Development, International Organization Collaboration, and Development of New Medicines at the Lekhim Group of Companies, representative of the Association of Employers' Organizations in the Medical and Microbiological Industry of Ukraine (AEOMMIU)

Mykhailo Renskyi

The project of the NRA concept.

Serhii Sur

Director, Arterium LTD

Serhii Sur

Opinion of domestic manufacturers regarding the milestones and timelines of the implementation of new legislative requirements.

Petro Bagriy

President of the Association of Drug Manufacturers of Ukraine (ADMU).

Petro Bagriy

Readiness of domestic manufacturer for new requirements.

Yevheniya Piddubna

Head of the Healthcare Committee of the Union of Ukrainian Entrepreneurs (UUE), Director of Corporate Communications of JSC Farmak.

Yevheniya Piddubna

Single National Regulatory Authority — open questions.

Volodymyr Ihnatov

Executive Director of the Association of International Pharmaceutical Manufacturers (AIPM Ukraine)

Volodymyr Ihnatov
16:00-17:00 (GMT +3)
Panel 3.

Distributors and pharmacy networks: how the establishment of NRA will affect pharmacy retailers.

Moderator: Evgenia Lukyanchuk, Product Manager of PHARMACY Weekly.

Challenges and opportunities for domestic distributors in the conditions of changing rules of the game — the vision of public organizations.

Tetyna Kotliar

Head of the PUBLIC ASSOCIATION "All-Ukrainian Pharmaceutical Union "PHARMUKRAINA", Head of the Public Council at the State Service of Ukraine on Medicines and Drugs Control.

Tetyna Kotliar

Readiness of national pharmacy retailers to meet European requirements.

Ihor Chervonenko

Chairman of the Board of the Public Association «Pharmacy Professional Association of Ukraine».

Ihor Chervonenko

A model of the pharmacy business of the future post-war Ukraine.

Oleg Klimov

Head of the Board of the NGO "All-Ukrainian Pharmaceutical Chamber" (NGO "PIM"), member of the Council of the International Pharmaceutical Federation (FIP), (online).

Oleg Klimov

Medical products, cosmetics, disinfectants: the impact of the establishment of NRA.

Pavlo Kharchyk

President of the Association AMOMD® (online)

Pavlo Kharchyk
17:00-17:45 (GMT +3)
Panel 4.

Staffing for the work of NRA.

Kostyantyn Kosyachenko, Adviser to the Director of the State Expert Center of the Ministry of Health of Ukraine, Head of the Department of Organization and Economy of Pharmacy of the Bogomolets National Medical University, Doctor of Pharmaceutical Sciences, Professor, Honored Pharmacy Worker.

Panel discussion.

Alla Kotvitska

Rector of the National University of Pharmacy (NUP), Doctor of Pharmaceutical Sciences, Professor, Honored Worker of Science and Technology of Ukraine.

Alla Kotvitska

Serhii Ubohov

Head of the Department of Medical Personnel, Education and Science of the Ministry of Health of Ukraine, Doctor of Pharmaceutical Sciences, Professor

Serhii Ubohov

Viacheslav Kaminskyi

Rector of the Shupyk National Healthcare University of Ukraine, Doctor of Medical Sciences, Professor, Member of the National Academy of Medical Sciences of Ukraine, Honored Doctor of Ukraine.

Viacheslav Kaminskyi

17:45-18:00 (GMT +3)

Concluding remarks

Yevhen Kunda

CEO Proxima Research International

Yevhen Kunda
Buffet
18:15-20:30 (GMT +3)

Buffet

map

Speakers of the event

Viacheslav Kaminskyi
Viacheslav Kaminskyi

Rector of the Shupyk National Healthcare University of Ukraine, Doctor of Medical Sciences, Professor, Member of the National Academy of Medical Sciences of Ukraine, Honored Doctor of Ukraine.

Yevhen Kunda
Yevhen Kunda

CEO Proxima Research International

Yevhen Kunda
Yevhen Kunda

CEO Proxima Research International

Emer Cooke
Emer Cooke

Executive Director of the European Medicines Agency (EMA) (video message).

Björn Eriksson
Björn Eriksson

Director General of the Swedish Medical Products Agency (online)

Organizers and partners

pharmexpert

2023

The general sponsor

pharmexpert

2023

Location with shelter

Location

Kyiv city, Parkova road, 16a

Event location
CEC «Parkovy»
location-place