19-20 September, 2024
2 days
English
240 EUR
online: Zoom platform (8 hours/day)
Entry requirements: Doctors participating in clinical trials
Application starts: open
Application deadline: 13 Sep, 2024
OVERVIEW
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)
Entry requirements
The course is designed for doctors participating in clinical trials.
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
For registration please fill out the following online application 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.
Required language proficiency
Upper Intermediate English knowledge
Main topics
- Management of PSMF, and PVAs
- GVP Modul III Inspection
- GVP Modul IV – audits
- GVP Modul V – VII – Risk management systems; Periodic safety update report
- GVP Modul VI – Management of reports of suspected adverse reactions
- GVP Modul VI – Management of reports of suspected adverse reactions
- GVP Modul IX – Signal management
- GVP Modul VIII and X
- GVP Modul XV and XVI
- Challanges of drug safety considering innovative drug development.
- MDR – Medical device vigilance, introduction
- Future data sources for pharmacovigilance use
- Artificial intelligence and drug safety
- Ecopharmacovigilance
- Engagement of HCP for pharmacovigilance
- Pharmacovigilance map of CEE and Balkan region
- Latest scientific pharmacovigilance advancements
