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

Edward 'O' Connor
Sep 23, 2019 - 01:00 PM EDT
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This training will discuss the regulatory requirements and processes for re-analysis of biologics and small molecules.

Why Should You Attend:

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.

This presentation will be a broad-ranging systematic plan of evaluating re-analysis during Pk and Immunogenicity testing and problem resolution will be presented. Steps to ensure success including company and assay specific criteria will be described.

In conclusion, this webinar will educate the participant on the processes, effects, impact, and solutions to sample re-analysis with attention to regulatory mandates.

Areas Covered in the Seminar:

  • 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).

Who Will Benefit:

  • Executive management
  • Pre-clinical and clinical scientists,
  • Regulatory Specialists
  • Bioanalytical Chemists/Scientists
  • QA/ QC
  • Marketing
  • Consultants
  • Trainers
Webinar Events
Attend Live Webinar
Sep 23, 2019 - 01:00 PM EDT

Duration: 60 Minutes

Single Attendee

Group of 3-5 Attendees

Group of 6 to 10 + DVD-USB

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Edward 'O' Connor,

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. Edward'O'Connor, PhD, is a consultant supporting Bioanalytical method development, validation and application to non-clinical and clinical sample analysis. His background includes directing these efforts at a number of CROs including Tandem Labs, TherImmune, Covance, Oread and Mason Research as well as Biotech's MedImmune, Biogen and Elusys.

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