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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Data Related International Policy and Strategy: EVDAS, E2B (R3), GDPR

Session Chair(s)

Harmonie  Etienne, MSc

Harmonie Etienne, MSc

Pharmacovigilance Advisor

Dr. Ebeling & Assoc. GmbH, Germany

This session will discuss the expectations from the authorities regarding the use of one of the biggest EudraVigilance database in Europe (EVDAS) to further evaluate validated signals. Whereas the analysis of this big data base constitutes big challenges, solutions regarding how to handle this data will be presented. This will be followed by an example of how to use the new E2B R3 XML message for a more meaningful exchange of safety information between license partners.Finally, in May 2018, EU GDPR was put into force to protect personal data which had a huge impact on the way pharmaceutical company use personal data. Challenges and key elements to be compliant with this regulation will be highlighted.

Learning Objective : Define new responsibilities associated with EVDAS ; Discuss solutions to meet the regulatory challenges; Identify advantages and impact on data quality regarding the newest format (E2B(R3)) for case reporting; Define EU GDPR regulation with a special focus on areas that have a particular importance to pharmaceutical companies.

Speaker(s)

Harmonie  Etienne, MSc

EudraVigilance Data Analysis System: How Marketing Authorization Holder Can Meet the New Challenges

Harmonie Etienne, MSc

Dr. Ebeling & Assoc. GmbH, Germany

Pharmacovigilance Advisor

Uwe Peter Trinks, PhD, MS

Using the E2B R3 XML Message for Safety Data Exchange Between License Partners

Uwe Peter Trinks, PhD, MS

IQVIA, United States

Global Practice Lead, IQVIA

Thomas  Hornbaek Svendsen, MS

EU GDPR and What it Means to Clinical Research

Thomas Hornbaek Svendsen, MS

NNIT A/S, Denmark

Managing Consultant

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