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Session 4: Article 57 Database and How Data in Medicines is Used for Pharmacovigilance
Session Chair(s)
Sabine Brosch, PharmD, PhD, MPharm
Data Protection Officer
European Medicines Agency, Netherlands
Subhash N. Mistry
Systems Manager
GSK, United Kingdom
This session will focus on the achievements of the Article 57 database in delivering structured and quality assured information on medicinal products authorised in the EU that can support EU terminologies of products, substances, and organisations used to power pharmacovigilance and regulatory systems. Key emphasis will be put on the current and future use of the data in support of pharmacovigilance and how data quality is assured.
Speaker(s)
Current Status on Article 57 Submissions and Quality Assurance
Ana-Silvia Cochino
European Medicines Agency, Netherlands
Scientific Administrator
Article 57 – Use of the Data for Public Health and Better Regulation
Paolo Alcini
European Medicines Agency, Netherlands
Head of Healthcare Data
Article 57 Database – an Industry Perspective
Subhash N. Mistry
GSK, United Kingdom
Systems Manager
Panel Discussion
David John Lewis, PhD
Novartis Pharma Gmbh, Switzerland
Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance
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