Semmelweis University – 6th Pharmacovigilance in practice – Good Vigilance Practice course
Essential information:
- Organizer: Semmelweis University, Department of Pharmacology and Pharmacotherapy
- Audience: pharmacovigilance professionals (entry level for general training, mid-senior level for field specific information), healthcare professionals
- Date: 18–19 September 2025
- Language: English
- Fee: 95 000 HUF
- Venue: Online course via Zoom
- Outcome: GVP Training certificate after successful written exam
For registration, please click here
Training summary:
The 6th Pharmacovigilance in Practice – Good Vigilance Practice (GVP) course, organized by Semmelweis University, offers a comprehensive overview of the European Union’s GVP requirements. It combines regulatory insights with practical, field-specific knowledge to support the day-to-day work of pharmacovigilance professionals.
The curriculum covers all GVP Modules, delivered by both regulatory authorities and industry experts. Additional topics include pharmacovigilance management, medical device vigilance, and the latest academic research developments in the field.
While the course is primarily designed for pharmacovigilance specialists, professionals from related fields, such as regulatory affairs, medical affairs, and quality assurance, as well as healthcare providers, will also benefit from the in-depth content.
Upon successful completion, participants will receive a certificate recognized by the pharmaceutical industry, validating their knowledge of GVP. This certificate is also accepted as external training for pharmacovigilance professionals.
This course is a valuable opportunity to gain a thorough understanding of all key areas of pharmacovigilance in a practical and engaging format.
In case of any questions please contact with pharma.education@semmelweis.hu
Downloadable course data sheet
List of lectures
| Index | Day | Appoint. | Duration (min.) | Title of the presentation | Performer | Position/academic degree |
|---|---|---|---|---|---|---|
| 0 | 18.09.2025 Thursday | 8:45 | 15 | Welcoming and introduction Learning outcome | Dr. Mátyás Pétervári | Semmelweis University |
| 1 | 18.09.2025 Thursday | 9:00 | 60 | GVP Modul I – II Pharmacovigilance systems, Pharmacovigilance System Master File Specialized topic: Management of PSMF, and PVAs | Dr. Barbara Nyiri | Gedeon Richter Plc. |
| 2 | 18.09.2025 Thursday | 10:00 | 45 | GVP Modul III Inspection | To be decided | NNGYK (Hungarian NCA) |
| 18.09.2025 Thursday | 10:45 | 15 | BREAK | |||
| 3 | 18.09.2025 Thursday | 11:00 | 30 | GVP Modul IV - audits | Dr. Barbara Nyiri | Gedeon Richter Plc. |
| 4 | 18.09.2025 Thursday | 11:30 | 45 | GVP Modul V - VII - Risk management systems; Periodic safety update report | Bíróné Dr Zsuzsanna Sándor (Modul V) Dr. Tamara Téglás (Modul VII) | NNGYK (Hungarian NCA) |
| 18.09.2025 Thursday | 12:15 | 45 | LUNCH BREAK | |||
| 5 | 18.09.2025 Thursday | 13:00 | 45 | GVP Modul VI – Management of reports of suspected adverse reactions | To be decided | |
| 6 | 18.09.2025 Thursday | 13:45 | 60 | GVP Modul IX – Signal management | Dr. Mátyás Pétervári | Semmelweis University |
| 18.09.2025 Thursday | 14:45 | 15 | BREAK | |||
| 7 | 18.09.2025 Thursday | 15:00 | 30 | GVP Modul VIII and X | Dr. Júlia Pallós | PRAC member, NNGYK |
| 8 | 18.09.2025 Thursday | 15:30 | 30 | GVP Modul XV and XVI Safety communication and additional Risk Minimization Measures | Tamás Balázsa | NNGYK |
| 9 | 19.09.2025 Friday | 8:45 | 45 | Challanges of drug safety considering innovative drug development. | Prof. Dr. Péter Ferdinandy | MTA doctor, Semmelweis University (SU) university professor/university associate professor |
| 10 | 19.09.2025 Friday | 9:30 | 60 | MDR – Medical device vigilance, introduction | Dr. Ágnes Horváth | CE Certiso Ltd. |
| 19.09.2025 Friday | 10:30 | 15 | BREAK | |||
| 11 | 19.09.2025 Friday | 10:45 | 45 | Medical device risk management | To be decided | |
| 12 | 19.09.2025 Friday | 11:30 | 45 | Safety referral procedures in the EU | Dr. Melinda Pálfi | NNGYK |
| 19.09.2025 Friday | 12:15 | 45 | LUNCH BREAK | |||
| 13 | 19.09.2025 Friday | 13:00 | 45 | Pharmacovigilance management survival toolkit | Dr. Mátyás Pétervári | Semmelweis University |
| 14 | 19.09.2025 Friday | 13:45 | 45 | Engagement of HCP for pharmacovigilance | Dr. Balázs Máté Ádám | Semmelweis University |
| 19.09.2025 Friday | 14:30 | 15 | BREAK | |||
| 15 | 19.09.2025 Friday | 14:45 | 45 | Benefit-risk assessment of medicines | Dr. Balázs Takátsy | Gedeon Richter Plc. |
| 16 | 19.09.2025 Friday | 15:30 | 45 | Latest scientific pharmacovigilance advancements | Dr. Balázs Máté Ádám | Semmelweis University, Department of Pharmacology and Pharmacotherapy |
For registration, please click here
Basic data
| Main title | Pharmacovigilance in practice – Good Vigilance Practice |
| Code number | |
| Semester | II. semester 2025 |
| Nature | Optional |
| Condition | Qualified program |
| Organizer | Semmelweis University, Department of Pharmacology and Pharmacotherapy |
| Contact person | Dr. Anikó Görbe, 2104416 |
| Partner | Sanovigado Ltd. |
| Target group | 1. 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 |
| University | Vocational and Continuing Education Center of Semmelweis University |
| Accr.point | 20 |
| Start | 18.09.2025 |
| End | 19.09.2025 |
| Location | Zoom platform |
| Days | 2 |
| Course hours | 16 |
| Exam | yes |
| Price | 95000 HUF |
| Application deadline | 12.09.2025 |
| Comment | https://semmelweis.hu/pharmacology/oktatas/posztgradualis-tanfolyamok/pharmacovigilance-in-practice-good-vigilance-practice-2025-september/ |
| Can participants register on the portal? | yes |
Vocational college(s)
| Numb. | Vocational college(s) | Point | Comment |
|---|---|---|---|
| 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 |