German Pharmacovigilance Day
The 4th German Pharmacovigilance Day aims to provide information about e.g. EU wide standardisation and simplified reporting via the new ICH-E2B (R3) format, new data elements and additional requirements. Additionally, it will focus on the MAHs’ access to EudraVigilance with regard to the EV Database Warehouse and Analysis System (EVDAS) and data output in form of an electronic Reaction Monitoring Report (eRMR). The mentioned changes will have considerable impact on the overall PV system and need to be appropriately addressed within the PSMF (Pharmacovigilance System Master File).
Official language: German
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The 4th German Pharmacovigilance Day aims to provide information about e.g. EU wide standardisation and simplified reporting via the new ICH-E2B (R3) format, new data elements and additional requirements. Additionally, it will focus on the MAHs’ access to EudraVigilance with regard to the EV Database Warehouse and Analysis System (EVDAS) and data output in form of an electronic Reaction Monitoring Report (eRMR). The mentioned changes will have considerable impact on the overall PV system and need to be appropriately addressed within the PSMF (Pharmacovigilance System Master File). Official language: German50.0420515 8.5362063
| Wann |
04.05.2017 von 09:00 bis 17:00 |
|---|---|
| Veranstaltungsort | Lufthansa Flight Training Center Frankfurt |
| Stadt | Frankfurt a.M. |
| Kontaktname | Stefania Sarga |
| Zielgruppe |
This conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care system dealing with the Pharmacovigilance system, such as: Pharmacovigilance dept. Clinical operation dept. Statistic dept. Medical Affairs dept. Regulatory Affairs dept. Quality & Compliance dept. in pharmaceutical and Biotech companies, Clinical Research Organizations (CROs) and publich health centers. |
| Termin übernehmen |
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