EUCRAF is pleased to announce the names of the speakers of Seminar 4.1. Seminar 4 is composed of two parts.

Part I is held in January 2012 on Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier:sources and main characteristics of biopharmaceuticals; European CMC data requirements for the marketing authorization (Module3) and for the IMP; comparability; formulation development; isoform characterization and glycosylation; virus and TSE safety; stability of biopharmaceuticals; bioassay establishment and data presentation; new approaches in the manufacture - platform technologies and QbD; CMC data requirements in the USA and Japan and the special characteristics of the International Nonproprietary Name system (INN) for biopharmaceuticals.

Part II is held in March 2012 on the non-clinical and clinical development of biopharmaceuticals including biosimilars and the module 4 and 5 requirements and immunogenicity. Cases studies on monoclonal antibodies, erythropoietin and a biosimilar and a case presentation on the tri-functional monoclonal antibody Catumaxomab will be presented.

Speakers of Part I:

Dr. Beatrix Metzner from MerckSerono and Prof. Jean-Yves Pabst from the University of Strasbourg are the Course Leaders of this seminar.

Dr. Andreas Bechthold from the University of Freiburg introduces sources and main characteristics of biopharmaceuticals.

Dr. Raffaella Balocco from WHO presents International Nonpropriatory Name (INN) of biopharmaceuticals.

Dr. Hannelore Wilkommen from Regulatory Affairs & Biologocal Safety Consulting discusses the safety of starting material of animal and / or human origin used in the process or formulation of the medicinal product.

Dr. Manuel Zahn from 3R Pharma Consulting gives an insight into the stability of biopharmaceuticals.

Dr. Michael Ausborn from Roche explains formulation and drug product manufacturing of biopharmaceuticals.

Dr. Hans-Joachim Wallny from Novartis speaks about bioassay.

Dr. Beatrix Metzner presents Quality Module 3 of the CTD for recombinant and classical biopharmaceuticals; characterisation, quality control and analytical techniques; essential differences in Module 3 considerations USA; essentials for Module 3 in Japan and changes in process and their implications on the molecule, the comparibility excercise.

Dr. Fiona Greer from SGS M-Scan speaks on isoform, molecular subspecies characterisation and glycosylation.

Dr. Ole Schou (fromerly Novonordisk) introduces insulin as an example for use of individual manufacturing methods .

Dr. Pascal Wehrle from the University of Strasbourg presents ICH Q8: Introduction into the concept of Quality by Design and Design Space.