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Thursday, June 18 • 5:00pm - 6:00pm
#521 OD: ON DEMAND - Data Related International Policy and Strategy: EVDAS, E2B (R3), GDPR

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Component Type: Session
Level: Basic

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 Objectives

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.

Chair

Harmonie Etienne, MSc

Speaker

EudraVigilance Data Analysis System: How Marketing Authorization Holder Can Meet the New Challenges
Harmonie Etienne, MSc

Using the E2B R3 XML Message for Safety Data Exchange Between License Partners
Uwe Trinks, PhD, MS

EU GDPR and What it Means to Clinical Research
Thomas Hornbaek Svendsen, MS


Speakers
avatar for Thomas Hornbaek Svendsen

Thomas Hornbaek Svendsen

Managing Consultant, NNIT A/S
Thomas Hornbaek Svendsen works as managing consultant at NNIT and has more than 20 years of consulting experience within the life sciences domain with special focus on regulatory affairs and key expertise within document management, submission management and registration tracking... Read More →
avatar for Harmonie Etienne

Harmonie Etienne

Pharmacovigilance Advisor, Dr. Ebeling & Assoc. GmbH
Harmonie completed her studies in biochemistry, molecular & cell biology and molecular physiopathology. She joined the medical science and PV department of Dr. Ebeling & Assoc. GmbH – an experienced pharma consultancy in January 2019. Early on, she got involved in the development... Read More →
avatar for Uwe Trinks

Uwe Trinks

Global Practice Lead, IQVIA
Dr. Uwe Trinks, Global Practice Lead, PV Technology at IQVIA serves as Drug Safety and Risk Management Subject Matter Expert with over 32 years of life sciences experience. Prior to joining IQVIA, he served as Partner and Director of Foresight Group International for 10 years and... Read More →
UT

Uwe Trinks

Global Practice Lead, IQVIA
Dr. Uwe Trinks, Global Practice Lead, PV Technology at IQVIA serves as Drug Safety and Risk Management Subject Matter Expert with over 32 years of life sciences experience. Prior to joining IQVIA, he served as Partner and Director of Foresight Group International for 10 years and... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session |   11: Statistics, Session