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Session 4 National Guidance/Policy Developments Regarding Biosimilars
Session Chair(s)
Sabine Atzor, MPHARM, RPH
Head of EU Regulatory Policies
F. Hoffmann-La Roche Ltd, Switzerland
2015 is marked by a number of position and policy developments regarding biosimilars in European countries. The session aims to provide details regarding these policies and guidelines touching upon real world evidence, market access, health technology assessment, prescription, interchangeability and guidelines for healthcare professionals and patients. This session will help to identify trends, communalities and differences.
Speaker(s)
The Netherlands: Medicines Evaluation Board (MEB) Updated Position on Prescription of Biosimilar Medicinal Products and National Switching
Leon van Aerts, PHD
Medicines Evaluation Board, The Netherlands, Netherlands
Paul Ehrlich Institut (PEI) Position on Interchangeability of Biosimilars
Elena Wolff-Holz, MD, PHD
Paul-Ehrlich Institut, Germany
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor
Finland: Position of Finnish Medicines Agency (FIMEA) on Interchangeability of Biosimilars
Pekka T Kurki, MD, PHD
Finnish Medicines Agency, Finland
Research Professor
Ireland: The Irish Health Products Regulatory Authority: Guide to Biosimilars for Healthcare Professionals and Patients
Sean Barry, PHD
Health Products Regulatory Authority (HPRA), Ireland
Senior Pharmaceutical Assessor