Overview

This on-demand course provides a practical foundation for effectively communicating drug safety information to patients, healthcare professionals, and other stakeholders. Participants will explore the definition of risk in the context of medicinal products, the goals of safety communication, and the tools available to support clear, accurate, and audience-appropriate messaging. The course also addresses health literacy principles, effective presentation of statistical risk information, stakeholder roles and responsibilities, and methods for evaluating communication effectiveness, including considerations for crisis and digital communication, to support informed decision-making and promote patient safety.

This on-demand training course takes an average of 6 hours to complete. Learners have access to the course for one year from the date of purchase.

What you will learn

- Defining “Risk” in the Context of Medicinal Drug Products
- What Should be the Goals of Risk Communication?
- Health Literacy and Designing Effective Risk Communication
- Successful Risk Communication
- Risk Communication Tools for Patients and Healthcare Professionals
- Who’s Responsible for Communicating Drug Safety Information?
- Evaluating Effectiveness of Risk Communication
- Effective Presentation of Statistical Risk Information
- Special Topics

Who should attend?

This program is designed for professionals involved in:

Drug safety and pharmacovigilance, especially safety evaluation and periodic safety reporting
Clinical trial design and operation
Quality systems
Medical writing
Regulatory strategy and regulatory affairs
Regulatory policy
Labeling operations and label development
Risk management plan development, and risk minimization program design, implementation and evaluation (including for formal EU Risk Management Plans and US REMS)
Benefit-risk assessment of medicinal products

Learning objectives

At the conclusion of this course, participants should be able to:
- Define risk in the context of medicinal drug products and the goals of risk communication in supporting safe use and informed decision-making
- Describe characteristics of effective and successful risk communication, including transparency, timeliness, audience tailoring, and alignment with regulatory expectations
- List health literacy principles and best practices to design clear and accessible risk communication materials for patients and healthcare professionals
- Differentiate among available risk communication tools
- Identify roles and responsibilities of key stakeholders in communicating drug safety information
- Evaluate the feasibility and effectiveness of risk communication tools, including the appropriate presentation and interpretation of statistical risk information

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Safety-Risk Communications for Medicinal Products

Overview

What you will learn

Who should attend?

Learning objectives

Be informed and stay engaged.