戻る Agenda
Session 3 Continued
Session Chair(s)
Thijs Giezen, PHARMD, PHD, MSC
Medicines Evaluation Board, Netherlands
Challenges associated with pharmacovigilance, traceability, global naming for biologicals as well as new approaches to biosimilar development will be shared and debated in this session.
Speaker(s)
EuropaBio Survey of Physician Preferences for Information Sources and Contents of a Biosimilar Label (SmPC) in 7 EU Member States (2015)
Keith Watson, PHD
AbbVie Ltd, United Kingdom
Director, Global Regulatory Affairs, Biologics Strategic Development
Panel Discussion
Elena Wolff-Holz, MD, PHD
Paul-Ehrlich Institut, Germany
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor
Xavier Kurz, MD, PHD, MSC
European Medicines Agency, Netherlands
Head of Data Analytics Workstream
Raffaella Giovanna Balocco Mattavelli, PHARMD, PHD
World Health Organization (WHO), Switzerland
Group Lead, International Nonproprietary Name Programme
Pieter Stolk, PHARMD, PHD
University Medical Centre Utrecht, Netherlands
Project Manager
Elke Grooten, MPHARM
Novartis, Belgium
Head EU Relations