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European Medicines Agency

2023 年 11 月 21 日 9:30 上午 - 2023 年 11 月 21 日 5:30 下午

Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands

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.

Future Trends at EMA

Speaker(s)

Loris  Piccolo

Loris Piccolo

European Medicines Agency, Netherlands

Data Science Specialist

Rodrigo  Postigo

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

Rodrigo Postigo

European Medicines Agency, Netherlands

Signal Management Lead, Pharmacovigilance Office

Eugene P. van Puijenbroek, MD, PhD

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

Eugene P. van Puijenbroek, MD, PhD

Netherlands Pharmacovigilance Centre Lareb, Netherlands

Head of Scientific Department

Luis  Pinheiro, PharmD, MSc

Opportunities to use Artificial Intellegence in Signal Detection

Luis Pinheiro, PharmD, MSc

European Medicines Agency, Netherlands

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce

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