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Session 3: Signal Detection and Management by Marketing Authorisation Holders
Session Chair(s)
Georgy Genov, MD
Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
European Medicines Agency, Netherlands
Sabine Straus, MD, PhD, MSc
PRAC Chair, Staff Member
Medicines Evaluation Board (MEB), Netherlands
This session will cover the Marketing Authorisation holders (MAHs) perspectives and approaches taken in order to comply with their pharmacovigilance obligations, following the release of the EudraVigilance data. The key changes and modifications of the internal process to incorporate EudraVigilance monitoring will be highlighted. Furthermore, the steps within the signal management process in relation to the key aspects considered during a pharmacovigilance inspection will be explored.
Speaker(s)
Pharmaceutical industry perspective on the EU Signal Management process: Key changes in the process
David John Lewis, PhD
Novartis Pharma Gmbh, Switzerland
Head QPPV PRRC Office, Patient Safety & Pharmacovigilance
Signal Management by MAHs: Steps to incorporate the EudraVigilance data into safety surveillance
Alison Turney, PharmD
Eli Lilly and Company, United States
Sr. Director, Global Patient Safety (GPS) Signal Management Process Owner
EU Signal Management process and Pharmacovigilance Inspections: Good practices in the MAHs signal management process
Kiernan Trevett, MSc
Genentech, A Member of the Roche Group, United States
Principal Quality Lead, PDQ Quality Assurance Process GVP
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