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Facts & Myths About Orphan Drug Development
Wednesday, January 30, 2019, 12:00 PM - 1:00 PM EST
Category: HBSHAA Webinar

OVERVIEW

International Regulatory Affairs expert Xavier Luria will delve into the specific of orphan drug development, elaborating on areas that often lead to confusion, while highlighting similarities and differences of this process in the U.S. and Europe.
 
SPEAKER
 
Xavier Luria, Founder, Chief Executive and Senior Consultant, DDR; Head of Safety and Efficacy of Medicines, European Medicines Agency
 
BIOGRAPHY
 
Xavier Luria, is Chair and Senior Consultant at Drug Development and Regulation (www.ddrmedic.com) based in Barcelona and London. Additionally, he sponsors a unique Business Center for biotechnology and health related companies and entrepreneurs in Barcelona (Support Business Center: www.supportbusinesscenter.com). He was Head of Safety and Efficacy at the European Medicines Agency (EMA) during 2005-2012, and previously held leadership positions in the biopharmaceutical industry for more than eighteen years, covering international clinical development, pharmacovigilance, biostatistics and medical affairs. In addition to Xavier’s specialty in internal medicine, pharmaceutical medicine and biostatistics, he has developed expertise in several specific therapeutic areas and carried out postgraduate qualification in clinical pharmacology, drug development and regulation (Tufts University School of Medicine, Boston). He is a recognized expert on regulatory systems and procedures and benefit-risk assessment. He is professor and invited lecturer in various academic institutions in USA and Europe. He has been extensively involved setting up strategy, design and operations of drug development programs and post-marketing drug surveillance, as well as on portfolio management and in-and-out licensing opportunities. As independent consultant he provides strategic and hand-on support for regulatory plans and activities in Europe and has set up an experts' network through preferential high quality collaborations covering Europe, USA, Latin America and Japan.

Contact: [email protected]