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The Future of the EU Orphan Drug Network
Session Chair(s)
Keith Watson, PhD
Director, Global Regulatory Affairs, Biologics Strategic Development
AbbVie Ltd, United Kingdom
This session discusses the significant benefit and similarity orphan consultations and explores what this means for the EU orphan sector. We will explore the drivers behind the new requirements, strategic product considerations and discuss the impact for industry, regulators and importantly, the patients themselves.
Learning Objective : Understand the impact of the revised notice from the Commission on aspects of the application of Article 3, 5 and 7 of Regulation (EC) N° 141/2000 on orphan medicinal products and proposed changes to Commission Regulation 847/2000, the “similarity regulation
Speaker(s)
Web Application to Assess Similarity
Pedro Franco, PharmD, PhD, MS, MSc
Merck Serono Limited, United Kingdom
Senior Director for Global Regulatory & Scientific Policy (GRASP)
Kristina Larsson, MS
European Medicines Agency, Netherlands
Head of Orphan Medicines, Division for Human Medicines Evidence Generation
Virginie Hivert, PharmD, PhD
Eurordis-Rare Diseases Europe, France
Therapeutic Development Director
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