Serious adverse events along with their cousins, serious adverse reactions, anticipated events, unanticipated events and unanticipated problems are often confused and misunderstood.

Why Should You Attend:

Regulations and guidance can be overwhelming and seem conflicting when it comes to handling serious adverse events.

Areas Covered in this Webinar:

This webinar on serious adverse events, will show you why it is important to know when and what needs to be submitted, reviewed, and approved by an Institutional Review Board (IRB) and what can be handled by the investigator as non-reporting of events that are considered reportable can lead to issues related to non-compliance.

Learning Objectives:

ICH guidelines and Good Clinical Practice (GCP)
Department of Health and Human Services (DHHS) guidance
Food and Drug Administration (FDA) guidance
Potential effects on consent and the protocol

Who Will Benefit:

Human Subjects Research Personnel
Clinical Research Personnel
New Clinical Research Coordinators
New Principal Investigator Positions
Administration in charge of Clinical Research
Regulatory Compliance Personnel

Speaker Profile:

Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program.

For more detail please click on this below link:


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