Taking immunogenicity assessment of therapeutic proteins to the next level
Begin:
Thursday, 10.06.2010
End:
Friday, 11.06.2010
Location:
Paul-Ehrlich-Institut
Host:
An International Association for Biologicals (IABS), Paul-Ehrlich-Institut (PEI), International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and European Immunogenicity Platform (EIP) conference.
Chairperson
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 productspecific 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.
Participants
Maximum of 150 delegates from regulatory agencies, academia and industry.
Key Topics
- EU perspective on immunogenicity assessment
- Update on regulatory approaches – comparability exercise and biosimilars
- Identification of clinical risk – what can we learn from case studies?
- Reflections on immunogenicity assessment – pathogenesis of unwanted immune responses
Panel discussion – next steps on immunogenicity assessment
