Overview

This virtual training course provides a comprehensive framework on benefit-risk of medicinal products. Participants will learn about the principles, legal, and regulatory basis for benefit-risk obligations and frameworks for compliance. Fundamentals of benefit-risk assessment will be covered, including methods commonly used and incorporation of the patient perspective. Participants will be able to apply the key concepts learned to conduct a benefit-risk assessment and select tools to optimize benefit-risk balance.

“This DIA course provided a concise and comprehensive overview of the complex topic of Benefit Risk Assessment. The Instructor was very effective in conveying the concepts and answering questions that arose during the course. I really enjoyed the course!”

-Previous Participant

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What you will learn

Legal and regulatory basis for benefit and risk obligations, including a historical perspective
Principles, basic definitions, and frameworks for compliance
Fundamentals of performing benefit-risk assessment
Importance of the patient perspective and incorporation into the benefit-risk equation
Risk minimization tools and the circumstances for which they are deployed
Measuring effectiveness of risk minimization
How and why the benefit-risk equation evolves over time
Benefit-risk assessment and selection of tools to minimize risks while maximizing benefit to the patient

Who should attend?

This program is designed for professionals involved in:

Drug safety and pharmacovigilance
Safety evaluation
Periodic safety reporting
Medical monitoring
Medical communication call centers
Medical writers
Regulatory strategy and regulatory affairs
Clinical research
Risk management planning and development of formal Risk Management Plans/REMS
Disciplines that interact with or support safety and pharmacovigilance functions across the product lifecycle to broaden their roles within pre-market or post-market safety and pharmacovigilance functions

Learning objectives

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

Identify the history, principles, and regulatory framework for benefit-risk assessments and management
Define the basic definitions of terms used in day-to-day benefit-risk work
Select and maintain a benefit-risk assessment plan
Identify a benefit-risk assessment
Select appropriate risk minimization tools
Define the importance of the patient in assessing benefit-risk balance

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