Virtual Summit “Rare Disease Therapies Development”

February 27, 2023 | Virtual

We are pleased to announce that we will be joining Virtual Summit “Rare Disease Therapies Development” as speakers. This summit provides a unique opportunity to pharma and biotech companies to share non-IP knowledge and best practices.

Join our speakers Xavier Prugnard and Daniel Garcia for their presentation “Orphan Drug Designation EU and US, regulatory strategy, incentives and key points to consider”.

Published on:
February 13, 2023
About the presentation “Orphan Drug Designation EU and US, regulatory strategy, incentives and key points to consider”

This presentation will explore the opportunities and challenges of the Orphan Drug Designations in US and EU with a view to informing regulatory strategies for the successful registration of rare disease products and enable faster access to treatments for patients. Participants will gain valuable insights into when and how to consider applying for Orphan Drug Designation (eligibility criteria, timelines, benefits) to optimize the clinical development and registration of your drug in the US and EU markets.

Our Speakers:

Xavier Prugnard

Regulatory Affairs Senior Director Pharma Xavier has joined Alira Health in 2023 with 17 years of regulatory experience in the pharmaceutical industry, ranging from early to late-stage compounds as well as marketed products, in various therapeutic areas including anti-infectives, neurosciences, ophthalmology and oncology.

Previously, Xavier has worked for 12 years at F.Hoffmann-La Roche Ag (Roche) in Basel in roles of increasing responsibilities, developing global regulatory strategies, meeting with numerous health authorities in US, Europe and international countries as well as successfully leading global teams for: registrations of new drugs and new indications, scientific advice, orphan drug designations and various other regulatory activities. Xavier also worked in the UK at GlaxoSmithKline (GSK) and Allergan earlier in his career.

Xavier is a Doctor of Pharmacy and holds a Master of International Regulatory Affairs from the University of Paris.

Daniel García

Director Regulatory Affairs Daniel has over a decade of regulatory experience in the pharmaceutical industry. Prior to joining Alira Health in 2021, Daniel served as Senior Regulatory Manager at a consulting firm (DDR, now Veristat). Daniel has also held positions at Lundbeck and Sanofi.

Daniel holds a Master’s Degree in Pharmaceutical Industry from Universitat de Barcelona (Spain), MsPharm degree in Pharmacy from Universidad de Salamanca (Spain), and postgraduate qualification in pharmacoeconomics (Pompeu Fabra University). Daniel is specialized in nonclinical assessment of safety and toxicology requirements of medicinal products.
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