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SIGNAL MANAGEMENT USING EVDAS (GVP MODULE IX)
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
Taking into account the phased implementation of the EudraVigilance signal management by MAHs, which started in February 2018 in the form of a pilot focusing on a limited number of active substances of medicinal products subject to additional monitoring, EMA announced in August the extension of the pilot beyond February 2019 to allow for additional experience to be gained. This session is dedicated to discuss how industry has approached the new signal management and eRMR assessment and the lessons learned so far.
Speaker(s)
Experience with the EudraVigilance signal detection pilot from an industry perspective
Alexandra Szabo, PHARMD
Gedeon Richter Plc., Hungary
Head of Signal & Risk Management
How to approach the eRMR assessment for innovative medicines?
Christiane Michel, DrMed, MSC
Novartis Pharma AG, Switzerland
Global Head Safety Signal Detection
eRMR assessment for generics
Andreas Iwanowitsch
STADA Arzneimittel AG , Germany
Director Medical Affairs / Corporate PV, EU QPPV