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Workshop

IMMUNOGENICITY: Understanding The Regulatory Philosophy

13-14 October 2014, Munich, Germany

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Following its inaugural introduction in 2012, EUCRAF is proud to announce its 2nd workshop on Immunogenicity taking place in Munich, Germany on October 13 - 14, 2014. The central theme of this workshop is Understanding The Regulatory Philosophy that will specifically examine topics on how to comply and fulfill regulatory expectations for presentation of information required to mitigate immunogenicity-related risks of biotherapeutics.

Objective

The aim of this 1.5-day interactive workshop is to discuss and clarify suitable approaches for satisfying regulatory expectations for presentation of the information required to enable a balanced assessment of risks of undesirable immunogenicity.

Synopsis

The availabe regulatory guidelines explain the factors to be considered in planning and presenting studies on immunogenicity. However, the format of the regulatory dossier – both for clinical trial applications and marketing authorisation applications – does not provide an obvious opportunity to present a balanced and integrated assessment of the multitude of factors that could potentially interact to induce undesirable immunogenicity as well as the tailored measures to detect and mitigate the risks in order to contribute to a positive benefit/risk of the product.

In this workshop, EUCRAF brings together two experienced practitioners, Pekka Kurki from the Finnish Medicines Agency, a leading regulatory expert who has been closely involved in defining the EU regulatory approach, and Paul Chamberlain, an industry representative who has prepared immunogenicity data sections of regulatory dossiers for diverse product types, to debate options for an optimal strategy.

The programme incorporates presentations and interactive discussions that will explain the regulator’s perspective, allied to case examples to illustrate the nature of the information that should be included in regulatory submissions. Particular emphasis will be placed on explaining how the different elements of the risk identification process – intrinsic immunogenicity, systems biology, product quality attributes and conditions of use – may be integrated with the results of the non-clinical and clinical immunogenicity risk evaluation, and then linked to the Risk Management Plan.

Distinguishing features of this workshop

• Applied approach based on substantial experience of regulatory procedures

• Multi-disciplinary perspective

• Linkage of data presentation to a structured risk assessment

We look forward to welcoming you in Munich, 13 October 2014!

Your EUCRAF Team