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
Index | Day | Appoint. | Duration (min.) | Title of the presentation | Performer | Position/academic degree |
---|---|---|---|---|---|---|
1. | 05.10.2023 Thursday | 09:00 | 45 | Challanges of drug safety considering innovative drug development. | Prof. Dr. Péter Ferdinandy /Dr. Anikó Görbe | MTA doctor, Semmelweis University (SU) university professor/university associate professor |
2. | 05.10.2023 Thursday | 09:45 | 60 | GVP Modul I – II Pharmacovigilance systems, Pharmacovigilance system master file Specialized topic: Management of PSMF, and PVAs | Dr. Gábor Erdei | Senior Pharmacovigilance Compliance Manager, Richter Gedeon Plc. |
3. | 05.10.2023 Thursday | 10:45 | 15 | BREAK | ||
4. | 05.10.2023 Thursday | 11:00 | 60 | GVP Modul III – IV Inspection and audits. | Dr. Gábor Koncsik | Pharmavigilance Manager, Servier Hungaria Ltd. |
5. | 05.10.2023 Thursday | 12:00 | 60 | LUNCH BREAK | ||
6. | 05.10.2023 Thursday | 13:00 | 60 | GVP Modul V - VII - Risk managements systems; Periodic safety update report. | Dr. Viktória Kis | Head of Department, Egis Gyógyszergyár Zrt. |
7. | 05.10.2023 Thursday | 14:00 | 60 | GVP Modul VI – Management of reports of suspected adverse reactions. Additional topic: Management of ICSRs from social media, and combined (medical information, product quality complaint) sources | Dr. Kristóf Kovács | Case management team leader, Egis Gyógyszergyár Zrt. |
8. | 05.10.2023 Thursday | 15:00 | 15 | BREAK | ||
9. | 05.10.2023 Thursday | 15:15 | 60 | GVP Modul VIII and X | Dr. Júlia Pallós | PRAC member, NNGYK |
10. | 06.10.2023 Friday | 09:00 | 60 | GVP Modul IX – Signal management | Dr. Mátyás Pétervári | Semmelweis University, Department of Pharmacology and Pharmacotherapy |
11. | 06.10.2023 Friday | 10:00 | 60 | GVP Modul XV and XVI | Dr. Júlia Pallós | PRAC member, NNGYK |
12. | 06.10.2023 Friday | 11:00 | 15 | BREAK | ||
13. | 06.10.2023 Friday | 11:15 | 60 | MDR – Medical device vigilance | Dr. Ágnes Horváth | CE Certiso Ltd. |
14. | 06.10.2023 Friday | 12:15 | 60 | LUNCH BREAK | ||
15. | 06.10.2023 Friday | 13:15 | 60 | Implementation of websites, software and mobile applications for pharmacovigilance purposes | Dr. Mátyás Pétervári | Semmelweis University, Department of Pharmacology and Pharmacotherapy |
16. | 06.10.2023 Friday | 14:15 | 60 | Artificial intelligence and drug safety. | Dr. Mátyás Pétervári | Semmelweis 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 title | Pharmacovigilance in practice – Good Vigilance Practice |
---|---|
Code number | |
Semester | II. semester 2023 |
Nature | Optional |
Condition | Qualified program |
Organizer | Semmelweis University, Department of Pharmacology and Pharmacotherapy |
Contact person | Dr. Anikó Görbe, 2104416 |
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 | 32 |
Start | 05.10.2023 |
End | 06.10.2023 |
Location | Zoom platform |
Days | 2 |
Course hours | 16 |
Exam | yes |
Price | 35000 HUF |
Application deadline | 30.09.2023 |
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 |