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Session 5A: Industry Perspective on Biotherapeutics & Biosimilar Products
Session Chair(s)
Thomas Kirchlechner, PhD
Head, Regulatory Emerging Markets
Sandoz Biopharmaceuticals Development (Novartis), Austria
This panel session aiming at providing an all-encompassing perspective on the Biotherapeutics and Biosimilar products fi eld. As such, the session has been divided into two sections. The first one includes perspectives by industry experts, while the second is comprised by a panel of regulatory agencies officials specialized in the topic. A dynamic and interactive panel discussion with the audience will take place at the end of the second section for all stakeholders to visit on the multiple views provided by the panelists.
Speaker(s)
Introduction /Biosimilar Monoclonal Antibodies and Advanced Therapies
Thomas Kirchlechner, PhD
Sandoz Biopharmaceuticals Development (Novartis), Austria
Head, Regulatory Emerging Markets
Biosimilar Products in Brazil
Edilson Uiechi, DVM
Libbs, Brazil
Regional and Global Perspective
Ana Padua, MSc, RPh
EMD Serono, Switzerland
Director EU Global Regulatory and Scientific Policy
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