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: 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 2024
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.point20
Start19.09.2024
End20.09.2024
LocationZoom platform
Days2
Course hours16
Examyes
Price95000 HUF
Application deadline13.09.2024
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

 

List of lectures

IndexDayAppoint.Duration (min.)Title of the presentationPerformerSemmelweis University, Department of Pharmacology and Pharmacotherapy
0.19.09.2024 Thursday08:4515Welcoming and introduction Learning outcomeDr. Mátyás PéterváriSenior PV Compliance Manager, deputy QPPV; Global Regulatory Science Directorate  /  Global Patient Safety Department  /  Global Pharmacovigilance Compliance Unit, Richter Gedeon Plc.
1.19.09.2024 Thursday09:0060GVP Modul I – II Pharmacovigilance systems, Pharmacovigilance system master file
Specialized topic: Management of PSMF, and PVAs
Dr. Gábor ErdeiGMP/GDP/GVP Inspector, Hungarian NCA
2.19.09.2024 Thursday10:0045GVP Modul III InspectionHatem Adel Ph.D.
19.09.2024 Thursday10:4515BREAKAurobindo APL Swift Services (Malta) Ltd.
3.19.09.2024 Thursday11:0030GVP Modul IV - auditsBarbara Reithauser-NyíriHead of Department, Egis Gyógyszergyár Zrt.
4.19.09.2024 Thursday11:3045GVP Modul V - VII - Risk management systems; Periodic safety update reportDr. Viktória Kis
19.09.2024 Thursday12:1545LUNCH BREAKCase management team leader, Egis Gyógyszergyár Zrt.
5.19.09.2024 Thursday13:0045GVP Modul VI – Management of reports of suspected adverse reactionsDr. Kristóf KovácsSemmelweis University, Department of Pharmacology and Pharmacotherapy
6.19.09.2024 Thursday13:4560GVP Modul IX – Signal managementDr. Mátyás Pétervári
19.09.2024 Thursday14:4515BREAKPRAC member, NNGYK
7.19.09.2024 Thursday15:0030GVP Modul VIII and XDr. Júlia PallósPRAC member, NNGYK
8.19.09.2024 Thursday15:3030GVP Modul XV and XVIDr. Júlia PallósPosition/academic degree
IndexDayAppoint.Duration (min.)Title of the presentationPerformerMTA doctor, Semmelweis University (SU)
9.20.09.2024 Friday08:4545Challanges of drug safety considering innovative drug development.Prof. Dr. Péter Ferdinandy /Dr. Anikó Görbeuniversity professor/university associate professor
10.20.09.2024 Friday9:3060MDR – Medical device vigilance, introductionDr. Ágnes HorváthCE Certiso Ltd.
20.09.2024 Friday10:3015BREAK
11.20.09.2024 Friday10:4545Future data sources for pharmacovigilance useMaurizio Sessa
12.20.09.2024 Friday11:3045Artificial intelligence and drug safetyJan PetracekInstitute of Pharmacovigilance
20.09.2024 Friday12:1545LUNCH BREAK
13.20.09.2024 Friday13:0045EcopharmacovigilanceJoan DsouzaISOP
14.20.09.2024 Friday13:4545Engagement of HCP for pharmacovigilanceDr. Máté Ádám BalázsSemmelweis University
20.09.2024 Friday14:3015BREAK
15.20.09.2024 Friday14:4545Pharmacovigilance map of CEE and Balkan regionDr. Mátyás PéterváriSemmelweis University, Department of Pharmacology and Pharmacotherapy
16.20.09.2024 Friday15:3045Latest scientific pharmacovigilance advancementsDr. Szandra MartonSemmelweis University, Department of Pharmacology and Pharmacotherapy

 

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

 

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