The Program of the pharmaceutical forum “PHARMA@FOCUS ON THE PATIENT 2024. PHARMACOVIGILANCE”, which will take place on 07 March 2024 in Kyiv, has been published.
The Program provides for 2 thematic sessions and 3 panel discussions, which will be devoted, in particular, to the following issues:
SESSION 1. Pharmacovigilance. International cooperation
The session is devoted to Ukraine's place in the field of medicinal product safety surveillance on the international arena, the results achieved and prospects, and the presentation of European pharmacovigilance experience (Poland, Sweden).
Panel discussion 1. The importance of pharmacovigilance in the healthcare system
The issue will be discussed in a broad circle by representatives of the MoH of Ukraine, the Public Health Center, representatives of the State Expert Center for pharmacovigilance in the regions, and others.
Panel discussion 2. Pharmacovigilance in Ukraine. Staffing.
The discussion will address staffing issues and prospects for the development of the field – representatives of the Ministry of Health of Ukraine, the National University of Pharmacy (NUPh), P. L. Shupyk National Healthcare University of Ukraine, I. Ya. Horbachevsky Ternopil State Medical University and others will take part in the discussion.
SESSION 2. Selected issues of pharmacovigilance. Questions that have been answered
The session will address important issues of pharmacovigilance in special patient groups (European experience), the importance of reporting adverse reactions to medicinal products to ensure the quality of data obtained for regulatory decisions and to avoid medication errors; and the implementation of risk minimization measures from the perspective of the regulator and applicants.
Panel discussion 3. Inspections/audit of the pharmacovigilance system
The discussion is devoted to new approaches to inspections/audits of applicants’ pharmacovigilance systems, including European experience, current issues of pharmacovigilance system audits in wartime, results of targeted audits, and issues of inspection and self-inspection from the applicants’ perspective.
The Forum will result in the development and adoption of a joint resolution together with representatives of the pharmaceutical industry.
The following will take part in the event: Deputy Ministers of Health of Ukraine Serhii DUBROV and Maryna SLOBODNICHENKO (subject to confirmation), Director of the Center Mykhailo BABENKO, Deputy Director of the Center for Registration and Pharmacovigilance Yevheniia ISHKOVA (TKACHENKO), Head of the Pharmaceutical Directorate of the Ministry of Health of Ukraine Taras LIASKOVSKYI, Director of the Pharmacovigilance Department of the Center Tetiana BASHKATOVA, and specialists of the Center on expert evaluation of medicinal product safety materials, safety information monitoring and management, assessment of periodic safety update reports, and audits of applicants’ pharmacovigilance systems – Yevheniia SKORYK, Maryna LORYNETS, Mariia NESTERCHUK, Oksana HLUSHCHENKO.
At the Center’s invitation, distinguished international speakers will join the online event – representatives of the Uppsala Monitoring Center (UMC) and the EMA Pharmacovigilance Risk Assessment Committee (PRAC), as well as heads and pharmacovigilance specialists of European regulatory authorities:
- Peter HJELMSTRÖM, Director of Uppsala Monitoring Center, Sweden;
- Viola MACOLIC SARINIC, Scientific Lead of the EMA Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, Kingdom of the Netherlands;
- Mikhal HRYZ, Director of the Department for Inspection of Medicinal Products and Medical Devices, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Republic of Poland
- Andzhei CHESLAVSKY, Director of the Department of Adverse Reaction Monitoring of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Republic of Poland;
- Ulla WÄNDER LIMINGA, Scientific Director for Pharmacovigilance at the Swedish Medical Products Agency, PhD
Also, at the invitation of the organizers, participation is planned of pharmacovigilance representatives from the regions of the Center (Kharkiv, Lviv, Kyiv), the Public Health Center of the Ministry of Health of Ukraine, and representatives of the pharmaceutical market – Olha SADOVNYK, General Director of Rivnefarmatsiia TDV; Tamara PRYZYMYRSKA, Head of the Pharmacovigilance and Clinical Research Department of Gledpharm LTD LLC; Alla SOROKOLIETOVA, Director of the Department for Quality, Pharmacovigilance, Regulatory and International Medical Affairs of ASINO UKRAINE LLC; the Pharmacovigilance System Quality Manager of ASINO UKRAINE LLC; Olena MATVIEIEVA, Associate Professor of the Department of Pharmacology at O.O. Bogomolets National Medical University; Valentyna YAICHENI, Pharmacovigilance Manager at the representative office of AbbVie Biopharmaceuticals GmbH in Ukraine; and others.
You can view the event Program on the dedicated Forum page at https://pharmacovigilance.minisite.ai/; the document can be downloaded from the page of the Center's website at https://www.dec.gov.ua/news/zaproshuyemo-na-farmaczevtychnyj-forum-farmafokus-na-pacziyenta-2024-farmakonaglyad/
Recall that the organizers of the event are the State Expert Center of the Ministry of Health of Ukraine in cooperation with LLC “UkrComExpo”.
The forum aims to highlight the important role and significance of pharmacovigilance in the healthcare system of Ukraine, to draw attention to issues of global medicine safety and the conduct of pharmacovigilance in wartime. During the sessions and panel discussions, European experience in medicine safety surveillance, current issues of pharmacovigilance in Ukraine, and inspections/audits will be presented.
We invite you to participate!
Format – offline-online.
Venue of the event: Mercure Congress Centre conference hotel, Kyiv, Vadyma Hetmana St., 6.
Direct link to the Google form for registration https://docs.google.com/…/1WMPAYYm28TxGpEJ…/viewform…
