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Wednesday, February 6 • 15:15 - 16:15
#S0303: The New EudraVigilance System: One Year After

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Component Type: Session



Chair

Margaret Anne Walters

Speaker

Experience with Reporting and Accessing ICSRs in EV
Margaret Anne Walters

NCA Perspective
Rory Littlebury

Industry Experience with Signalling in EV
Christiane Michel, DrMed, MSc

Panel Discussion
Gaby L. Danan, MD, PhD



Speakers
avatar for Gaby Danan

Gaby Danan

Pharmacovigilance Expert, NA
Gaby Danan, MD, PhD, was the EU Qualified Person for Pharmacovigilance for Sanofi until his 2010 retirement. He has served on the Council for International Organizations of Medical Sciences and International Council on Harmonisation Expert Working Groups, especially as the European... Read More →
avatar for Rory Littlebury

Rory Littlebury

Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
Rory has ten years experience working at the MHRA, including working within Licensing and Pharmacovigilance Divisions prior to taking on a Pharmacovigilance Inspector role. Rory’s experience includes engagement as a regulator with a variety of stakeholders, from multi-national pharma... Read More →
avatar for Christiane Michel

Christiane Michel

Global Head Safety Signal Detection, Novartis Pharma AG
With more than 25 years of experience in Pharmacovigilance, Christiane is currently the Global Head of Safety Signal Detection & MedDRA Query Mgmt. at Novartis, Basel, Switzerland. She was trained as a medical doctor in Frankfurt, Germany and obtained her MSc in Epidemiology and Biostatistics... Read More →
avatar for Margaret Walters

Margaret Walters

Deputy EU Qualified Person for Pharmacovigilance, Merck, Sharp & Dohme Ltd
With 10 years in research and 30 in safety, Margaret is currently the Deputy EU Qualified Person for Pharmacovigilance at MSD Ltd. Activities include input to the EFPIA PV EWG, ICH, MedDRA (pre-ICH), the EMA EudraVigilance Steering Committee and the EWG, plus authoring papers on parasitology... Read More →


Wednesday February 6, 2019 15:15 - 16:15
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Pharmacovigilance
  • Tags Session