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Session 6: LOOKING BEYOND THE EU - GLOBAL OUTLOOK AND EXPERIENCES
Session Chair(s)
Sabine Atzor, MPharm, RPh
Head of EU Regulatory Policies
F. Hoffmann-La Roche Ltd, Switzerland
Elena Wolff-Holz, MD, PhD
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor
Paul-Ehrlich Institut, Germany
Speaker(s)
Biosimilar Infliximab Case Study<br>Approaches to extrapolation of indications
Elena Wolff-Holz, MD, PhD
Paul-Ehrlich Institut, Germany
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor
Biosimilar Infliximab Case Study<br>Canada view on Biosimilar Infliximab Marketing Authorization
Jian Wang, MD, PhD
Health Canada, Canada
Division Manager, Clinical Review Division – Heamatology/Oncology
Biosimilar Infliximab Case Study<br>Company Perspectives on Extrapolation and Indication – Biosimilar and industry view
Paul K. Audhya
Hospira UK, United Kingdom
Vice President, Medical Affairs Europe, Middle East, and Africa
Biosimilar Infliximab Case Study<br>Company Perspectives on Extrapolation and Indication – Biosimilar and industry view
Frederic Michel Ivanow, PharmD
Johnson & Johnson, United Kingdom
Senior Director, Global Regulatory Affairs
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