Back to 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)
Keith Watson, PHD
Director, Global Regulatory Affairs, Biologics Strategic Development, AbbVie Ltd, United Kingdom
EuropaBio Survey of Physician Preferences for Information Sources and Contents of a Biosimilar Label (SmPC) in 7 EU Member States (2015)
Elena Wolff-Holz, MD, PHD
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor, Paul-Ehrlich Institut, Germany
Panel Discussion
Xavier Kurz, MD, PHD, MSC
Head of Data Analytics Workstream, European Medicines Agency, Netherlands
Raffaella Giovanna Balocco Mattavelli, PHARMD, PHD
Group Lead, International Nonproprietary Name Programme, World Health Organization (WHO), Switzerland
Pieter Stolk, PHARMD, PHD
Project Manager, University Medical Centre Utrecht, Netherlands
Elke Grooten, MPHARM
Head EU Relations, Novartis, Belgium
Have an account?