Termin: Mittwoch, 25.01.2023 18:30 Uhr
Ort: Online ZOOM Konferenz
(Nach der Registrierung über den Link erhalten Sie die Zugangsdaten zu der Veranstaltung)
Federica Albissola, Global Regulatory Team Lead for Rare Diseases, Sanofi-Aventis Deutschland GmbH
Dr. Reinhold Rößler, Global Project Management Rare Diseases, Sanofi-Aventis Deutschland GmbH
Vortragstitel und Inhalt: “Accelerating regulatory approvals for new therapies: anexample from rare dise
Following a briefoverview of the development phases in the life of the drug, you will become familiar with the facilitated pathways that regulatory agencies offer to expedite the approval of drugs that target an unmet medical need. You will get an overview of the current Rare Disease policies, and then dive into apractical example from Rare Disease showing the background of the treated disease, the design of the clinical trials and the results of efficacy endpoints submitted to regulatory agencies. Finally, you will see how the facilitated pathways shortened the length of the approval timelines in several jurisdictions.
Kurzlebenslauf des Referenten:
Federica Albissola is a Global Regulatory Team Lead for Rare Disease at Sanofi. Federica joined Sanofi in 2017, where she led the regulatory activities for Olipudase Alfa first at European and then at global level. She is currently in charge of defining the global regulatory strategy for two assets from the Rare Disease pipeline in the early development stage.
Federica has 20 years of experience in Regulatory Affairs, with main focus on regulatory strategy, science and policy.
Prior to join Sanofi, she held a number of positions across various European countries in pharmaceutical companies (Vifor Pharma, Novartis, TorrentPharma, Siegfried), clinical research organization (Medpace) and engineering (LSMW).
Federica holds a MSin Chemical Engineering from the University of Genoa and an MBA from Vlerick Business Schoo
Reinhold Rößler has 25 years of experience in global project management and drug development in leading global pharmaceuticalcompanies.
Reinhold has managedpreclinical, early clinical, late stage, submission and post approval projects in the therapeutic areas of diabetes and metabolism. Currently he manages R&D projects for rare diseases at Sanofi Germany and US. His project expertise covers NCEs, NBEs, combination drugs and prolonged release formulations.
Reinhold graduated from the College of Pharmacy in Regensburg and holds a PhD in Pharmaceutical Technology from the University of Heidelberg. He is a certified business and team coach and university lecturer for projectmanagement in the pharmaceutical industry.
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