Back to Agenda
BIOSIMILARS
Session Chair(s)
Christian Schneider, DrMed
Head of Biopharma Excellence and Chief Medical Officer (Biopharma)
PharmaLex, Denmark
Genetically engineered proteinaceous macromolecules are required to pass through the centralised marketing authorisation procedure according to the Annex to Regulation (EU) 726/2004. The first growth hormones, epoetines, interferon’s, insulins and monocular antibodies are no longer covered by patent. They were authorised over 10 years ago. Generic companies therefore wish to conquer this market and obtain the necessary marketing authorisations – called Biosimilars, not biotech generics! The session summary will explain the requirements for marketing authorisations and Pharmacovigilance. An important subject is also the substitution of prescribed biosimilars by pharmacists. It is currently being discussed throughout Europe. The scientific experts will discuss this topic from a Pharmacovigilance perspective
Speaker(s)
Biologicals in Pharmacovigilance – Adverse Drug Reaction (ADR) reporting and traceability
Christian Schneider, DrMed
PharmaLex, Denmark
Head of Biopharma Excellence and Chief Medical Officer (Biopharma)
Biosimilars: Robust pharmacovigilance principles and patient safety
Peter De Veene, MD
MSD Belgium, Belgium
GQPPV
Biosimilar Industry’s Point of View
Pascale Burtin, MD, PhD
Sandoz International Gmbh, Germany
Head Clinical Develop. Biopharma
Have an account?