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Adverse Event Reporting:

Understanding Regulatory Reporting Requirements When Adverse Drug Reactions (I.E. Adverse Events) Occur At The Investigational Stage Of A Clinical Trial

Summary

  • Adverse Event (AE) and Serious Adverse Event Terminology: Definitions.
  • Roles & Responsibilities of the Sponsor and the Regulatory Agency in AE reporting.
  • Exclusions from SAE Reporting.
  • Causality Assessments.
  • Site Obligations.                                        
  • Investigator Notification Letters/ IND Safety Reports.
  • Case Studies and Scenarios.

Overview

This course will provide participants with an understanding of the regulatory reporting requirements when Adverse Drug Reactions (i.e. Adverse Events) occur at the investigational stage of a Clinical Trial. Adverse event identification and reporting requirements will be reviewed, as well as FDA and ICH roles in the drug safety process. The course will also discuss ICH guidelines and current regulatory issues regarding adverse event reporting requirements specific to the United States.

Who should attend?

  • Clinical research Professionals
  • Safety surveillance Personnel
  • Regulatory affairs Personnel
  • Medical affairs Personnel
  • QA/QC Managers

Nicole Tesar

Expert

Nicole began her career in Clinical Research over 17 years ago as a Clinical Research Associate for a small Clinical Research Organization. The accidental career that began after receiving her undergraduate degree has proven to be rewarding, challenging and continues to inspire her to do more and learn more in the field of Clinical Research. Nicole has held roles such as CRA, Lead CRA, Project Manager, Regional Operations Manager, and Auditor. In 2013 she started Harmony Clinical Consulting, providing consulting services to the pharmaceutical and biotech industries. Nicole has experienced working for Big Pharma as well as small Biotech companies.

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