Discussion on processes and effects of immunogenicity, screening methodologies to measure immune response, how to apply regulatory mandates and what are commercial repercussions of unwanted immune responses.
Why Should You Attend:
This webinar will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed. The comprehensive guidelines of regulatory agencies including the Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and the Committee for Medicinal Products for Human Use (CHMP)/ the European Medicines Agency will be covered.
This presentation will be a broad ranging systematic plan of evaluating immunogenicity during all phases of the product cycle, the regulatory mandates, risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.
In conclusion, this webinar will educate the participant on the processes and effects of immunogenicity, commonly adapted screening methodologies to measure immune responses, the application of regulatory mandates, and commercial repercussions of unwanted immune responses.
Areas Covered in the Seminar:
Overview on the processes and effects of immunogenicity.
Impact on efficacy and safety.
Screening and confirmatory methods to measure immune responses.
Regulatory guidelines on immunogenicity of biologics; FDA, ICH, CHMP, EMEA.
Risk management strategy.
Who Will Benefit:
Pre-clinical and clinical