EMA EudraVigilance and Signal Management Information Day

The first onsite EudraVigilance and Signal Management information day since 2018 is dedicated to update on EudraVigilance data protection activities, SPOR data activities, the revision of ICH-E2D, ICSRs quality control, key aspects and findings in PV Inspections related to EudraVigilance as well as EudraVigilance Operational activities.

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Future Trends at EMA

Speaker(s)

Loris Piccolo

Data Science Specialist, European Medicines Agency, Netherlands

Rodrigo Postigo

Signal Management Lead, Pharmacovigilance Office, European Medicines Agency, Netherlands

The new EMA signal and safety analytics project - What does it mean for Mahs and NCAs?

Eugene P. van Puijenbroek, MD, PHD

Head of Scientific Department, Netherlands Pharmacovigilance Centre Lareb, Netherlands

Insights from the SMART methods team on new methodologies used in EV

Luis Pinheiro, PHARMD, MSC

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands

Opportunities to use Artificial Intellegence in Signal Detection

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