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ON DEMAND - Data Related International Policy and Strategy: EVDAS, E2B (R3), GDPR
Session Chair(s)
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)
EudraVigilance Data Analysis System: How Marketing Authorization Holder Can Meet the New Challenges
Harmonie Etienne, MSc
Dr. Ebeling & Assoc. GmbH, Germany
Pharmacovigilance Advisor
Using the E2B R3 XML Message for Safety Data Exchange Between License Partners
Uwe Trinks, PhD, MS
IQVIA, United States
Global Practice Lead IQVIA PV Technologies
EU GDPR and What it Means to Clinical Research
Thomas Hornbaek Svendsen, MS
NNIT A/S, Denmark
Managing Consultant
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