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
1.05.10.2023 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
2.05.10.2023 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.
3.05.10.2023 Thursday10:4515BREAK
4.05.10.2023 Thursday11:0060GVP Modul III – IV Inspection and audits.Dr. Gábor KoncsikPharmavigilance Manager, Servier Hungaria Ltd.
5.05.10.2023 Thursday12:0060LUNCH BREAK
6.05.10.2023 Thursday13:0060GVP Modul V - VII - Risk managements systems; Periodic safety update report.Dr. Viktória KisHead of Department, Egis Gyógyszergyár Zrt.
7.05.10.2023 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.
8.05.10.2023 Thursday15:0015BREAK
9.05.10.2023 Thursday15:1560GVP Modul VIII and XDr. Júlia PallósPRAC member, NNGYK
10.06.10.2023 Friday09:0060GVP Modul IX – Signal managementDr. Mátyás PéterváriSemmelweis University, Department of Pharmacology and Pharmacotherapy
11.06.10.2023 Friday10:0060GVP Modul XV and XVIDr. Júlia PallósPRAC member, NNGYK
12.06.10.2023 Friday11:0015BREAK
13.06.10.2023 Friday11:1560MDR – Medical device vigilanceDr. Ágnes HorváthCE Certiso Ltd.
14.06.10.2023 Friday12:1560LUNCH BREAK
15.06.10.2023 Friday13:1560Implementation of websites, software and mobile applications for pharmacovigilance purposesDr. Mátyás PéterváriSemmelweis University, Department of Pharmacology and Pharmacotherapy
16.06.10.2023 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:  pharma.education@semmelweis.hu

Please, do not hesitate to contact us (pharma.education@semmelweis.hu) in case you need further information or have questions.

 

Basic data

Main titlePharmacovigilance in practice – Good Vigilance Practice
Code number
SemesterII. semester 2023
NatureOptional
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
Accr.point32
Start05.10.2023
End06.10.2023
LocationZoom platform
Days2
Course hours16
Examyes
Price35000 HUF
Application deadline30.09.2023
Website (more information about the course)https://semmelweis.hu/pharmacology/oktatas/posztgradualis-tanfolyamok/a-farmakovigilancia-gyakorlatban-good-vigilance-practice/
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
6.Neurosurgery
7.Cardiology
8.Traumatology and hand surgery
9.Medical laboratory
10.Oncology and radiation therapy
11.Surgery
12.Nephrology and dialysis
13.Neurological
14.Radiological
15.Orthopedic
16.Rehabilitation, physical medicine and medical aids
17.Rheumatology
18.Sports health
19.Heart surgery

 

Downloadable PDF