Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products

Why Should You Attend:

This course will provide participants with an understanding of the site and sponsor 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 regulatory 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.

Multiple case study exercises are included to reinforce the training material. Through the use of various scenarios, participants will learn how to assess and report AEs including SAEs.

Learning Objectives:

• Understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial.
• Learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.
• Become familiar with current issues regarding adverse event reporting specific to the United States.
• Have an understanding of what role the FDA and ICH guidelines play in determining the safety of a drug.
• Identify when a serious adverse event does not require reporting.
• Understand what the site obligations are in both assessing causality of adverse events as well as reporting these events to the sponsor.
• Learn the circumstances under which Investigator Notification Letters are released as well as responsibilities for notification of clinical sites as well as the FDA.

Areas Covered in the Webinar:

• Adverse Event (AE) and Serious Adverse Event Terminology: Definitions
• Roles and 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

Who Will Benefit:

This 60-minute overview is designed for those working in:

• Clinical research
• Safety surveillance
• Regulatory affairs
• Medical affairs
• QA/QC
• Any others who would benefit from a complete understanding of US regulations regarding monitoring and reporting of adverse events

Instructor Profile:

Nicole Tesar is owner and director of clinical operations at Harmony Clinical Consulting Corporation. She began her career in clinical research over 18 years ago as a clinical research associate for a small contract research organization. The unplanned 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.

Ms. Tesar 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. She has experienced working for “Big Pharma” as well as small biotech companies. Her focus is in oncology, rare disease and orphan drugs. She has had the opportunity of being a contributor in the development of the following products: Myleran® (Busulfan) for Pediatric BMT, Herceptin® (Trastuzumab) for Metastatic Breast Cancer, TYKERB® (Lapatinib) for Breast Cancer and MYALEPT® (metreleptin) for Lipodystrophy. Ms. Tesar is currently working as an independent consultant for Acerta Pharma BV in collaboration with The Ohio State University on a second generation BTK inhibitor to treat chronic lymphocytic leukemia.

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