Immunogenicity: Understanding the Regulatory Philosophy Workshop Summary

The 2nd EUCRAF Immunogenicity workshop was successfully held 13-14 October 2014 in Munich. This time the title was “Understanding the Regulatory Philosophy” and the event gathered around 40 participants from pharma and biotech companies from Austria, Germany, Denmark, Finland, France, Korea, Poland, Switzerland, US and the UK. The workshop presented an opportunity for participants to interact with Prof. Pekka Kurki from the Finnish Medicines Agency, a leading regulatory expert who has been closely involved in defining the EU regulatory requirements, and Paul Chamberlain, from Biopharma Excellence and NDA Advisory Board, a biopharmaceutical expert involved in the developing of immunogenicity packages of regulatory dossiers for diverse product types. In addition, Dr. Markku Toivonen from NDA Advisory Board also participated in the panel discussion. Dr. Gabriele Dallmann, from EUCRAF and Biopharma Excellence, moderated the workshop. The workshop aimed to discuss suitable approaches for satisfying regulatory expectations for presentation of the information required to enable a balanced assessment of risks of undesirable immunogenicity. To read more on the major outcomes of the sessions, please click on the following link.