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Session 1: Data Privacy – GDPR in Pharmacovigilance: Impact and Management of Data
Session Chair(s)
Gaby L. Danan, MD, PhD
Pharmacovigilance Expert, GLD, France
The aim of this session is to cover the key questions, examples on how has/is GDPR affecting pharmacovigilance. Incorporating different perspectives from industry and authorities, the 1st session of this interactive workshop will present what are the challenges and advantages when it comes to GDPR application in PV and what are the Non-EEA countries requirements vs. EAA harmonization.
Speaker(s)
Case Studies on how GDPR has/is Affecting Pharmacovigilance
Jean Kilgour-Christie, BSN, MSc
Deputy EU QPPV Head, UK QPPV, Sandoz International GmbH, Germany
Naveen Yelkur
Business Operations Executive, Bristol-Myers Squibb, United Kingdom
Non-EEA Countries Requirements vs. EAA Harmonization
Doris Irene Stenver, MD, MPA
Independent Pharmacovigilance Adviser, Unique Advice, Denmark
Panel discussion with Q&A
Gaby L. Danan, MD, PhD
Pharmacovigilance Expert, GLD, France
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