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Reportlinker Adds Immunogenicity to Biologics

d how much is too much? 2.12. Management of immunogencity aspects regarding product / process change during the clinical trial?

3. Post-marketing immunogenicity considerations 3.1. What kind or immune response monitoring is required?

3.2. What is the impact of formulation on immunogenicity 3.3. Influence of the route of administration on immunogenicity 3.4. How transport and storage can affect immunogenicity 3.5. Case study if possible: What changes were implemented and how were they monitored and dealt with regarding the regulatory authorities?

Chapter 7 EU Regulatory Guidelines and Advice on Working with Regulators

Dr Christian Schneider, Acting Head, EU Cooperation/Microbiology, Paul-Ehrlich-Institute

Part One: The CHMP Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Products

1. Background 1.1. Aims of the guideline 1.2. Regulatory background

2. Discussion of the guideline text 2.1. Risk factors 2.2. Predictivity of non-clinical models 2.3. Development of assays for humoral and cellular immune responses 2.4. Potential clinical consequences of immunogenicity 2.5. Pre-authorisation signal detection in the clinical setting 2.6. Risk management plan

3. Conclusion

Part Two: Practical Advice on Working with Regulatory Authorities

1. Possibilities for obtaining scientific advice in the European Union 1.1. Scientific Advice from National Competent Authorities (NCAs) 1.2. Scientific Advice and Protocol Assistance from the EMEA

2. Strategic planning of scientific advice

3. Rules in scientific advice

4. References

Chapter 8 Risk Minimisation & De-immunisation

PD Harald Kropshofer, PhD, Head of Immunosafety of Biotherapeutics, F. Hoffmann La Roche

1. Abstract

2. Introduction

3. Recognition of therapeutic proteins by immune cells

4. Modulators of immunogenicity 4.1. Drug-related modulators of im

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