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CURRENT AND FUTURE CHALLENGES IN PHARMACOVIGILANCE
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
In May 2018 the GDPR became applicable in the EU. The session will inform about the impact and challenges in the area of pharmacovigilance from a MAH perspective. Furthermore, new initiatives and developments as regards MedDRA will be summarised. The Information Day will conclude with an industry vision proposed for pharmacovigilance for the next years to come focusing on new technologies and new approaches to data management.
Speaker(s)
The impact of GDPR in pharmacovigilance
David John Lewis, PHD
Novartis Pharma Gmbh, Switzerland
Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance
MedDRA – what’s new?
Judy Harrison, MD
United States
Chief Medical Officer
New approaches on data collection and safety monitoring
Vicki Edwards, RPH
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV