Overview

Consistency in the safety data analysis and interpretation strategy throughout product development and clinical trials is paramount. This on-demand course will provide an improved understanding of the behaviors and ways of working related to successful safety planning. It will also provide perspective on what good safety data analysis looks like during each phase of development through interactive case studies and discussion.

This on-demand course takes an average of 9 hours to complete. Learners have access to the course for one year from the date of purchase.

Featured topics

How to review data and determine appropriate questions to ask
How to identify patterns in laboratory and adverse event data indicative of a safety signal
How to evaluate signals for possible confounding and bias
How to apply the principals of causality assessment based on CIOMS, FDA and Bradford Hill criteria
How to develop an aggregate safety analysis plan
How to approach signal detection in the post-marketing environment
Role of artificial intelligence and machine learning
Role of real-world evidence and real-world data

Who should attend?

This course is designed for professionals working in safety data sciences, product safety, as well as medical coders. The course may also be of value to statisticians.

Learning objectives

At the conclusion of this course, participants should be able to:

Determine how to detect and account for instances of bias and confounding
Utilize causality criteria to arrive at a decision regarding the causal role of a drug in producing an adverse event
Plan for aggregate data analysis throughout the product lifecycle
Identify safety considerations in clinical trials
Recognize how signal detection in post-marketing differs from clinical trial data
Determine the evolving use of RWD/RWE

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Data Science for Safety Professionals On-Demand Training

Overview

Featured topics

Who should attend?

Learning objectives

Be informed and stay engaged.