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THE NEW EUDRAVIGILANCE SYSTEM - ONE YEAR ANNIVERSARY (PART I)
Session Chair(s)
Sabine Brosch, PharmD, PhD, MPharm
Data Protection Officer
European Medicines Agency, Netherlands
Anja Van Haren, MSc
Eudravigilance coordinator
Medicines Evaluation Board (MEB), Netherlands
This session will provide a summary of the industry’s operational experience with EudraVigilance following the launch of the new system functionalities in November 2017. Following the integration of EudraVigilance with the new identity and access management of users and organisations in July 2018, an update will be provided on the achievements and challenges. The coding of medicinal product information reported in Individual Case Safety Reports (ICSRs) is based on the data provided by marketing authorisation holders (MAHs) as part of their Article 57 data submissions to the XEVMPD. The impact of the data coding on the ICSR download and the analysis in EVDAS will be explained. Questions from the audience will be addressed by the expert panel.
Speaker(s)
Sabine Brosch, PharmD, PhD, MPharm
European Medicines Agency, Netherlands
Data Protection Officer
Industry feedback on EudraVigilance new functionalities
Margaret Anne Walters
Merck, Sharp & Dohme Ltd, United Kingdom
Deputy EU Qualified Person for Pharmacovigilance
Identity and Access Management (IAM) integration with EudraVigilance
Dionne Usher
Merck Sharp & Dohme Limited, United Kingdom
Associate Director, Office of the EU QPPV
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