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Programme

Immunogenicity: Understanding the regulatory philosophy

13-14 October 2014

Munich, Germany

Sheraton Hotel

Prof Pekka Kurki, Finnish Medicines Agency (FIMEA)

Paul Chamberlain, NDA Advisory Board

Moderator

Dr Gabriele Dallmann

DAY 1 (13 October 2014)

11.30 - 13.00 Registration and welcome snacks and refreshments
13.00 - 14.30 Workshop
14.30 - 15.00 Coffee break
15.00 - 17.30 Workshop
17.30 End of the day
18.00 Transfer to the venue of the social event
18.30 Social event

SESSION 1: Overview of regulatory philosophy

  • Evolution of the regulatory approach related to the immunogenicity requirements (Pekka Kurki)
  • What is meant by a “risk-based approach” to immunogenicity assessment from the regulator’s perspective? (Pekka Kurki)
  • How is immunogenicity assessed for different product types, from biosimilars to enzyme/factor replacement therapies? (Paul Chamberlain)
  • What are the implications of this philosophy for data presentation? (Pekka Kurki and Paul Chamberlain)
  • Q & A / Discussion (All)

SESSION 2: What are the pertinent risk factors?

  • Intrinsic immunogenicity & systems biology (Paul Chamberlain)
  • Conditions of use & patient-related factors (Pekka Kurki)
  • Product quality (Paul Chamberlain)
  • Q & A / Discussion (All)

DAY 2 (14 October 2014)

08.30 - 09.00 Welcome coffee
09.00 - 10.30 Workshop
10.30 - 11.00 Coffee break
11.00 - 13.00 Workshop
13.00 - 14.00 Lunch break
14.00 - 16.00 Workshop
18.30 End

SESSION 3: Evaluation of risks and contribution of immunogenicity assessment to the overall benefit-risk assessment

  • Case examples illustrating impact of product type on nature of bioanalytical data package (Paul Chamberlain)
    • Recombinant analogue of endogenous protein / peptide
    • Yeast-derived therapeutic protein
    • Biosimilar anti-TNF mAb
  • Clinical evaluation of immunogenicity and how does it contribute to the benefit-risk assessment (Pekka Kurki)
  • Dealing with “Tricky cases”: 2 examples (Paul Chamberlain)
  • Q & A / Discussion (All)

SESSION 4: Managing uncertainty in the post-authorisation setting

  • Role of the Risk Management Plan (Pekka Kurki)
  • Q & A / Discussion (All)

SESSION 5: Effective presentation of data in the CTD format

  • The “Integrated Summary of Immunogenicity” model (Paul Chamberlain)
  • How to tell a good story (Pekka Kurki)
  • Q & A / Discussion (All)