PARTICIPANT'S LOGIN
Presentations will be available online following the conference. Participants will be sent a username and password to access the presentations at that time.
HEAR FROM LEADING EXPERTS
Paul Chamberlain (NDA, bioLOGICA)
Roy Jefferis (University of Birmingham)
Daniel Kramer (Merck Serono)
Harald Kropshofer (Hoffmann La-Roche)
Anthony Mire-Sluis (Amgen)
Tom Platts-Mills (Vanderbilt University School)
Jack Ragheb (FDA)
Amy Rosenberg (FDA)
Huub Schellekens (Utrecht University)
Christian K Schneider (PEI)
Philippe Stas (EIP, Algonomics NV)
Meena Subramanyam (Biogen Idec)
Robin Thorpe (NIBSC)
Jean-Hugues Trouvin (AFSSAPS)
Martina Weise (BfArM)
Contact us - IABS
International Association for Biologicals (IABS)
Web: www.iabs.org
Email: iabs@iabs.org
An IABS, PEI & IFPMA Conference on Biologicals
Taking immunogenicity assessment of therapeutic proteins to the next level
CONFERENCE OBJECTIVE:
• To enhance dialogue on the application of guidance on minimising risks associated with undesirable immunogenicity of therapeutic proteins, and how unwanted immunogenicity may have to be interpreted in a product-specific manner.
CONFERENCE VISION:
• To take the discussion to the next level: how immunogenicity should be assessed from a regulatory point of view, what is its impact on benefit/risk and in which direction future regulatory guidance may have to go. The meeting should benefit from the presence of regulators, industry members and other experts from Europe and beyond.
CHAIRPERSON:
Christian K Schneider
Head of Division EU-Co-operation/Microbiology, PEI, Co-opted CHMP Member, BMWPand CAT Chairman, EMA.
PARTICIPANTS:
Maximum of 150 delegates from regulatory agencies, academia and industry.
SCIENTIFIC COMMITTEE
Jean-Hugues Trouvin (AFSSAPS)
Philippe Stas (EIP, Lonza (Algonomics))
Ryoko Krause (IABS, IFPMA)
Tony Lubiniecki (IABS, Centocor)
Christian K Schneider (PEI)
Isabel C Büttel (PEI)
Paul Chamberlain (NDA, bioLOGICA)
Anthony Mire-Sluis (Amgen)
