SFL Regulatory Affairs & Scientific Communication GmbH
|Date:||April 25, 2023|
|Time:||14:30 – 15:15|
From early diagnosis to access to treatments for rare diseases – European and US perspectives
The panel will discuss the particularities of developing and bringing new innovative medicines for rare diseases to the market and to patients. Speakers will present regulatory perspectives for orphan drugs in Europe and the US, as well as market access considerations in Europe with a focus on Switzerland and share the biotech perspective and particularities developing highly innovative products.
Nathalie Schober-Ladani, Senior Director Public Affairs and Regulatory Intelligence, SFL
Anja Bührer, Vice President Regulatory Affairs and Deputy Head of the SFL Group, SFL
John Kirk, Principal Regulatory Strategist, Veristat
Anna Ulbricht, Senior Director Medical Affairs and Market Access, SFL
Charlotte Chanson, Senior Director Global Diagnostics / Newborn Screening, Orchard Therapeutics
SFL, a Veristat company, is a premium consultancy providing integrated solutions to lifescience companies at global and local levels. Our multidisciplinary team support clients strategic and operational activities in Regulatory Affairs, Quality Assurance, Medical Writing, Public Affairs & Regulatory Intelligence, Reimbursement/Market Access, PV, and Healthcare Compliance. SFL can act as MA applicant/MAH in CH and EU and conduct submissions to FDA, PMDA, or other authorities.