Regulatory Strategy for Registering Rare Disease Products in the EU
Webinar Replay
In this webinar we focus on how to benefit, today and in the future, from the Orphan Drug program and build a regulatory strategy for successful rare disease product registration in the EU market.
According to European Medicines Agency about 30 million people living in the EU suffer from a rare disease. The Orphan Drug Regulation 141/2000 is a key European regulation that governs the research, development, and bringing to market of appropriate medications so that patients suffering from rare diseases can have the same quality of treatment as other patients.
In 2021, the European Commission proposed amendments to the Orphan Drug legislation that are still under discussion. What will the results of this review mean for companies looking to register their rare disease product in the EU market?
In this webinar you will learn:
- What is the current orphan drug regulation
- Why and how to get an Orphan Drug Designation
- How the regulatory changes may impact orphan drug developers
Meet Our Speakers
Damia Benchabane
Regulatory Affairs Director
Damia Benchabane joined Alira Health with 11 years of Regulatory Affairs experience in the pharmaceutical industry. Damia has worked in start-ups as well as mid-to-large pharmaceutical companies including LFB Biomédicaments, AB Science, Novartis, and GSK.
Damia has extensive experience in drug development and has led the registration and the lifecycle strategy of different medicinal products (biological, plasmatic, and chemical products) in the oncology, hematology, neurological disorders, and wound care fields. Damia has expertise in dealing with EU health agencies and has in-depth knowledge of regulatory pathways.
A Pharmacist by training, Damia holds a Master’s degree in Regulatory Affairs from Université de Lille.
Eric Armenteros
Regulatory Affairs Consultant
Prior to joining Alira Health, Eric worked in a regulatory consulting firm where he built his expertise on strategic regulatory roadmaps for global developments. He also has strong experience in orphan drug designations, expedited programs, scientific advice procedures, and marketing authorization preparedness/submissions.
Eric holds a Microbiology degree from Universitat Autònoma de Barcelona and a Master’s degree on the Pharmaceutical and Biotechnological Industry from Universitat Pompeu Fabra.
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In preparation for submitting the Phase III protocol for Myasthenia Gravis to the FDA and EMA, a multinational pharma sought support to incorporate early payer advice on the MG clinical trial design, identify evidence gaps, and provide insights on the overall development program for the asset.
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