German Pharmacovigilance Day 2018
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The big changes in the European Pharmacovigilance and Vigilance How to deal with the opportunities and pitfalls of the new EV system and the MDR? he German Pharmacovigilance Day 2018 will present how experts handle the new features of the EudraVigilance-System including EVDAS. What are the best strategies to overcome the huge workload and how to justify the newly defined processes in the own Pharmacovigilance- and Vigilance-System? Answers will be given in the perspective also of SMEs. However, also legal aspects and the view of Pharmacovigilance-Inspectors of Notified Bodies will be addressed.50.0324676 8.5922098
| Wann |
20.06.2018 von 09:15 bis 16:30 |
|---|---|
| Veranstaltungsort | InterCity Hotel Frankfurt Airport |
| Stadt | Frankfurt am Main |
| Kontaktname | Stefania Sarga |
| Kontakttelefon | +39(0)35.4123594 |
| Zielgruppe |
This one-day conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care system dealing with the Pharmacovigilance system, such as: Safety and Pharmacovigilance dept. Clinical operation dept. Statistic dept. Medical Affairs dept. Regulatory Affairs dept. Quality & Compliance dept. Legal dept. in Pharmaceutical and Biotech companies, Clinical Research Organizations (CROs) and public health centers. |
| Termin übernehmen |
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The big changes in the European Pharmacovigilance and Vigilance
How to deal with the opportunities and pitfalls of the new EV system and the MDR?
The German Pharmacovigilance Day 2018 will present how experts handle the new features of the EudraVigilance-System including EVDAS. What are the best strategies to overcome the huge workload and how to justify the newly defined processes in the own Pharmacovigilance- and Vigilance-System? Answers will be given in the perspective also of SMEs. However, also legal aspects and the view of Pharmacovigilance-Inspectors of Notified Bodies will be addressed.
During the day, the discussion will be also focused on:
• PSURs for Medical Devices
• Clinical Evaluation Plans and Clinical Expert Reports for Medical Devices
• ADR-reporting to Non-EU
• EVDAS access and main principles (signal detection and data analysis
• eRMR functionalities
• different levels of access to EudraVigilance
• and much more
Scientific Board
Leonardo Ebeling, Managing Director at Ebeling & Assoc. GmbH
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