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 (NNGYK), leading regional pharmaceutical companies)

Application form:

Language:             English

Location:             Online: Zoom

Date:              2024.09.19 – 2024.09.20

Price:                    95 000 HUF

For registration please fill out the following online application 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 2024
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
Price95000 HUF
Application deadline13.09.2024
Website (more information about the course)
Can participants register on the portal?Yes


List of lectures

IndexDayAppoint.Duration (min.)Title of the presentationPerformerPosition/academic degree Thursday08:4515Welcoming and introduction, Learning outcomeDr. Mátyás PéterváriSemmelweis University, Department of Pharmacology and Pharmacotherapy Thursday09:0060Specialized topic: Management of PSMF, and PVAsDr. Gábor ErdeiRichter Gedeon Plc. Thursday10:0045GVP Modul III InspectionTBDHungarian NCA
19.09.2024 Thursday10:4515BREAK Thursday11:0030GVP Modul IV - auditsBarbara Reithauser-Nyíri Thursday11:3045GVP Modul V - VII - Risk management systems; Periodic safety update reportDr. Viktória KisHead of Department, Egis Gyógyszergyár Zrt.
19.09.2024 Thursday12:1545LUNCH BREAK Thursday13:0045GVP Modul VI – Management of reports of suspected adverse reactions
Dr. Kristóf KovácsCase management team leader, Egis Gyógyszergyár Zrt.45GVP Modul VI – Management of reports of suspected adverse reactionsDr. Júlia PallósPRAC member, NNGYK Thursday13:4560GVP Modul IX – Signal managementDr. Mátyás PéterváriSemmelweis University, Department of Pharmacology and Pharmacotherapy
19.09.2024 Thursday14:4515BREAK Thursday15:0030GVP Modul VIII and XDr. Júlia PallósPRAC member, NNGYK Thursday15:3030GVP Modul XV and XVIDr. Júlia PallósPRAC member, NNGYK
IndexDayAppoint.Duration (min.)Title of the presentationPerformerPosition/academic degree Friday08:4545Challanges of drug safety considering innovative drug development.Prof. Dr. Péter Ferdinandy /Dr. Anikó GörbeMTA doctor, Semmelweis University (SU)
university professor/university associate professor Friday9:3060MDR – Medical device vigilance, introductionDr. Ágnes HorváthCE Certiso Ltd.
20.09.2024 Friday10:3015BREAK Friday10:4545Future data sources for pharmacovigilance useMaurizio Sessa Friday11:3045Artificial intelligence and drug safetyJan PetracekInstitute of Pharmacovigilance
20.09.2024 Friday12:1545LUNCH BREAK Friday13:0045EcopharmacovigilanceJoan DsouzaISOP Friday13:4545Engagement of HCP for pharmacovigilanceDr. Máté Ádám BalázsSemmelweis University
20.09.2024 Friday14:3015BREAK Friday14:4545Pharmacovigilance map of CEE and Balkan regionDr. Mátyás PéterváriSemmelweis University, Department of Pharmacology Friday15:3045Latest scientific pharmacovigilance advancementsSzandra MartonSemmelweis University, Department of Pharmacology


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


Downloadable PDF