SFL to present free webinar on the EU Orphan Drug Designation Regulations today
Daniela Kenzelmann Broz Director Medical Affairs, and Julien Gaudias Director Regulatory Affairs, will present a free webinar entitled “Orphan Drug Designation Application in the EU” (30 January, 2020, 4 to 5 pm CET). The webinar, moderated by Head of Regulatory Affairs Anja Bührer, will provide an overview of key aspects regarding the application for Orphan Drug Designation in the EU – relevant to any company developing orphan drugs. Specific topics will include incentives for designated orphan drugs, eligibility criteria and preparation of required documentation. An overview of the application evaluation process and timelines, along with a comparison of the EU ODD processes and regulations with other countries will also be presented.
Register now to take advantage of the expert insights provided by the SFL team on this important topic and find out how EU Orphan Drug Designation could benefit your products.
SFL is highly experienced in regulatory submissions, and can also provide both strategic and operational support for projects covering all life-cycle stages from early development to regulatory maintenance and market access/reimbursement of approved healthcare products, utilizing its unique combination of in-house expertise and a multi-disciplinary approach.