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Mar 22, 2018 11:00 AM - Mar 22, 2018 12:00 PM

(Eastern Standard Time)

Online

Complimentary - EudraVigilance and Signal Management Updates from EMA: Implications and Practical Aspects

Presenters

David J. Balderson, PhD

David J. Balderson, PhD

VP Global Safety Operations, Covance, United States

Worked in Pharmacovigilance for over 17 years, initially at GSK in the UK, followed by nine years at Amgen in the US including roles as Head of Safety Operations and Head of Regulatory Operations prior to joining Sciformix in 2015. Managed significant global changes in safety processes to improve overall business efficiency including the development of an electronic interface for serious adverse event collection in clinical trials and the implementation of a new safety system. Experienced in developing flexible business models while ensuring compliance and quality delivery.

Jose Alberto Ayala  Ortiz, MPharm, MSc

Jose Alberto Ayala Ortiz, MPharm, MSc

QPPV, PVpharm, Spain

José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.

Samuel  Wallis

Samuel Wallis

Senior Director, Global Drug Safety and Risk Management, Celgene Europe Ltd., United Kingdom

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