Xavier Luria Abstract .pdf


Nom original: Xavier Luria_Abstract.pdf
Auteur: Xavier Luria

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London · Barcelona · Amsterdam
+34935285385
info@ddrmedic.com

(DDR) Drug Development and Regulation

www.ddrmedic.com

Xavier Luria, MD is an independent consultant, founder and CEO at DDR
(Drug Development and Regulation - www.ddrmedic.com), located in
Barcelona, Amsterdam and London.
He was Head of Safety and Efficacy of Medicines at the European Medicines
Agency (EMA) 2005-2012, where he coordinated regulatory teams from the 28
European Member States in order to evaluate medicinal products for the whole
European Union. Dr. Luria was in charge of several cross-agency projects,
including implementation of electronic submissions using eCTD and the
development of other IT tools, review and reorganization of CHMP’s Working
Parties, coordination and expansion of the EMA’s Scientific Advisory Groups
(SAG), and new methodologies on Benefit/Risk assessment.
Prior to joining the EMA, Dr. Luria worked for 18 years in the pharmaceutical
industry, including 10 years as International Medical Director with
responsibilities in international clinical development, medical affairs, drug
safety and biometry, and other corporate functions.
In addition to Dr. Luria’s specialty in internal medicine, and pharmaceutical
medicine and biostatistics (University Autonomous Barcelona), he has
developed expertise in several specific therapeutic areas, carried out
postgraduate qualification in clinical pharmacology, drug development and
regulation (Tufts University School of Medicine, Boston), and he is a recognized
expert on regulatory systems and benefit-risk assessment (modelling,
development and methodologies).
Furthermore, he is module chair at an IFAPP-King’s College Postgraduate
Course, Senior Visiting Lecturer at the King’s College in London and lecturer at
several other academic institutions in Europe and USA.
He is also Expert Consultant at NDA Partners from 2012, and member of the
advisory board of several biopharmaceutical and medical devices companies
and serves as consultant and regulatory service provider to many others in
Europe, Japan, US, Australia, Israel and Latin America.

(DDR) Drug Development and Regulation
London · Barcelona · Amsterdam
+34 93 52 85 385 / www.ddrmedic.com

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