Semmelweis University offers the “Pharmacovigilance in practice – Good Vigilance Practice” accredited course organized by the Department of Pharmacology and Pharmacotherapy.

The course provides a wide picture of EU and Hungarian regulations in relation to drug, medical device, and food supplements safety. The lecturers have different backgrounds ensuring that the participants receive the most up-to-date information (Academia, Hungarian National Institute of Pharmacy and Nutrition (OGYÉI), leading regional pharmaceutical companies)


List of lectures

IndexDayAppoint.Duration (min.)Title of the presentationPerformerPosition/academic degree Thursday09:0045Challanges of drug safety considering innovative drug development.Prof. Dr. Péter Ferdinandy /Dr. Anikó GörbeMTA doctor, Semmelweis University (SU) university professor/university associate professor Thursday09:4560GVP Modul I – II Pharmacovigilance systems, Pharmacovigilance system master file Specialized topic: Management of PSMF, and PVAsDr. Gábor ErdeiSenior Pharmacovigilance Compliance Manager, Richter Gedeon Plc. Thursday10:4515BREAK Thursday11:0060GVP Modul III – IV Inspection and audits.Dr. Gábor KoncsikPharmavigilance Manager, Servier Hungaria Ltd. Thursday12:0060LUNCH BREAK Thursday13:0060GVP Modul V - VII - Risk managements systems; Periodic safety update report.Dr. Viktória KisHead of Department, Egis Gyógyszergyár Zrt. Thursday14:0060GVP Modul VI – Management of reports of suspected adverse reactions. Additional topic: Management of ICSRs from social media, and combined (medical information, product quality complaint) sourcesDr. Kristóf KovácsCase management team leader, Egis Gyógyszergyár Zrt. Thursday15:0015BREAK Thursday15:1560GVP Modul VIII and XDr. Júlia PallósPRAC member, NNGYK Friday09:0060GVP Modul IX – Signal managementDr. Mátyás PéterváriSemmelweis University, Department of Pharmacology and Pharmacotherapy Friday10:0060GVP Modul XV and XVIDr. Júlia PallósPRAC member, NNGYK Friday11:0015BREAK Friday11:1560MDR – Medical device vigilanceDr. Ágnes HorváthCE Certiso Ltd. Friday12:1560LUNCH BREAK Friday13:1560Implementation of websites, software and mobile applications for pharmacovigilance purposesDr. Mátyás PéterváriSemmelweis University, Department of Pharmacology and Pharmacotherapy Friday14:1560Artificial intelligence and drug safety.Dr. Mátyás PéterváriSemmelweis University, Department of Pharmacology and Pharmacotherapy


Language:             English

Location:             Online: Zoom

Date:              2023.10.05 – 2023.10.06

Price:            35 000 HUF* / 70 000 HUF

*For students, healthcare workers, or in public sector

For registration please fill out the following document (Registration Form), and/or contact us via email:

Please, do not hesitate to contact us ( in case you need further information or have questions.


Basic data

Main titlePharmacovigilance in practice – Good Vigilance Practice
Code number
SemesterII. semester 2023
ConditionQualified program
OrganizerSemmelweis University, Department of Pharmacology and Pharmacotherapy
Contact personDr. Anikó Görbe, 2104416 
Target group1. internal medicine | 2. internal medicine angiology | 3. vascular surgery | 4. pharmacology | 5. gastroenterology | 6. family medicine | 7. neurosurgery | 8. cardiology | 9. hand surgery | 10. clinic.lab.exam. (hygiene.) | 11. clinical biochemist | 12. clinical pharmacology | 13. clinical oncology | 14. thoracic surgery | 15. molecular biological diagnostician | 16. molecular genetic diagnostics | 17. nephrology | 18. neurology | 19. neuroradiology | 20. orthopedics | 21. orthopedics and traumatology | 22. medical laboratory diagnostics | 23. radiology | 24. rehabilitation medicine | 25. rheumatology | 26. surgery | 27. sports medicine | 28. heart surgery | 29. traumatology
UniversityVocational and Continuing Education Center of Semmelweis University
LocationZoom platform
Course hours16
Price35000 HUF
Application deadline30.09.2023
Website (more information about the course)
Can participants register on the portal?Yes


Vocational college(s)

Numb.Vocational college(s)
1.Internal medicine, endocrinology, diabetes and metabolic diseases
2.Angiology and vascular surgery
3.Clinical Pharmacology
4.Gastroenterological and hepatological
5.Home medicine
8.Traumatology and hand surgery
9.Medical laboratory
10.Oncology and radiation therapy
12.Nephrology and dialysis
16.Rehabilitation, physical medicine and medical aids
18.Sports health
19.Heart surgery


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