A pharmacovigilance forum will be held in Kyiv on March 07, 2024. Organizers: State Enterprise “State Expert Center of the Ministry of Health of Ukraine” in cooperation with UkrComExpo LLC.
Information partners: Main information partner: “Apteka Weekly”, information partner: “The Pharma Media”.
The following speakers from the Center will give presentations and reports during the Forum:
Yevheniia ISHKOVA (Tkachenko) – Deputy Director of the Center for Registration and Pharmacovigilance, Candidate of Pharmaceutical Sciences.
Has more than 15 years of experience in management and organization of processes in the pharmaceutical industry.
A repeated participant in leading thematic events in the field of medicine and pharmacy, scientific and practical conferences and seminars, including those with international participation.
Initiator and Head of the working group on the development and implementation in Ukraine of the new professional standard “Pharmacovigilance Professional”.
Tetiana BASHKATOVA – Director of the Center's Pharmacovigilance Department.
Has more than 15 years of experience in pharmacovigilance, in positions ranging from expert to department director.
She took a direct part in the development of the Procedure for Pharmacovigilance (MoH order No.898) and the Roadmap for the implementation of vaccination against COVID-19 in Ukraine, in the creation of the AISF (Automated Pharmacovigilance Information System), and takes measures to popularize it among medical and pharmaceutical workers and patients.
Has certificates of participation in WHO trainings on post-registration safety surveillance of medicinal products and vaccines, establishing a causal relationship between the use of a medicinal product and the occurrence of adverse events, and the cold chain.
Yevheniia SKORYK – Head of the Drug Safety Materials Expert Evaluation Directorate of the Center.
Has almost 5 years of experience in specialized expert evaluation of drug safety materials, from the position of expert to head of directorate.
Takes an active part in the development of regulatory documents and the implementation of international standards and EU legislation in the area of specialized expert evaluation of registration dossier materials and providing recommendations on the possibility of registration and re-registration of medicinal products and introducing amendments to registration dossier materials from the standpoint of medicinal product safety.
Participant in thematic seminars and trainings of the EMA and WHO.
Maryna LORYNETS – Head of the Division for Monitoring and Management of Safety Information and Evaluation of Periodic Safety Update Reports of the Center.
Experience in pharmacovigilance – 7 years. Worked her way up from expert to head of division.
Active member of the working group on updating pharmacovigilance legislation,
She took part in refining the AISF system in the signal generation section.
Mariia NESTERCHUK – Head of the Division for Audit of Applicants' Pharmacovigilance Systems of the Center. She has more than 7 years of experience as a physician and has been working for more than 7 years at the State Enterprise “State Expert Center of the Ministry of Health of Ukraine.” She is a certified specialist in accordance with the requirements and provisions of the international standards ISO 9001:2015 “Quality management systems” and ISO 19011:2018 “Guidelines for auditing management systems.” She takes an active part in the development and updating of regulatory documents and in the implementation of international standards and EU legislation in the field of pharmacovigilance. A participant in scientific and practical conferences and seminars, including those with international participation (EMA, FDA, MHRA, Health Canada).
Oksana HLUSHCHENKO – expert of the Division for Audit of Applicants’ Pharmacovigilance Systems of the Center. Has more than 10 years of experience in the field of pharmacy and 3 years of experience in pharmacovigilance. Certified specialist in accordance with the requirements and provisions of the international standards ISO 9001:2015 “Quality Management Systems” and ISO 19011:2018 “Guidelines for Auditing Management Systems”. Participant in thematic seminars and trainings of the EMA, FDA, MHRA, Health Canada.
