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Bioanalytcial sample re-analysis, ISR and analytical re-analysis

Sample re-Analysis for Assay/ Sample failure and Incurred Sample Re-Analysis

Summary

  • Overview on the sources of sample failure and requirements and limitation of re-analysis.
  • Impact on efficacy and safety.
  • Incorporating sample re-analysis acceptance and rejection criteria into general and method specific SOPs.
  • Regulatory guidelines on sample re-analysis and incurred sample re-analysis comparing FDA, ICH, CHMP, EMA documents.
  • Risk management strategy.
  • Relevant white papers discussing sample re-analysis ( incurred and for failure).

Overview

This webinar will provide an overview of the requirements both for failed assays and samples and for incurred sample re-analysis. The factors and considerations for failed samples and for incurred sample re-analysis and their impact on results, assay and report acceptance will be identified. A review and comparison of the relevant regulatory guidance 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.

Who should attend?

  • Executive management
  • Pre-clinical and clinical scientists,
  • Regulatory Specialists
  • Bioanalytical Chemists/Scientists
  • QA/ QC
  • Marketing
  • Consultants
  • Trainers

Edward 'O' Connor

Expert

Ed’O’Connor is currently senior consultant for Aegis Bio consulting. He has over 20 years in regulated bioanalysis serving in Director or manager level roles in Biotech at Alexion, Elusys, Biogen and Medimmune and At CROs including Matrix, Tandem, Therimmune and Covance. He has a PhD in Zoology from UMass Amherst and a BS degree from Texas A&M Commerce. His post-doctoral training focused on the neuroendocrine system in health and disease.

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