Safety Risk Communication for Medical Products On-Demand Course

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Safety Risk Communication for Medical Products

Keyword(s) Online learning; On Demand Training; Safety & Pharmacovigilance; FDA; EMA; Professional Development; Communication; Risk

This On-Demand Training course provides an introduction to the science of risk communication for medicinal products, the relevant regulatory context in the US and EU, the basics of risk communication in product risk management, and new directions in the field, including the use of digital and other eHealth methods and patient-centered approaches to risk communication. The course curriculum is directed at basic- through intermediate-level professionals who seek a greater understanding of the vital role of risk communication in medicinal product benefit-risk assessment, risk management and therapeutic treatment decision-making across the product lifecycle.

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Credit Information ACPE = 5
IACET = .5

Three professionals are seated at a table in a meeting room. The woman in the center holds a document that the two men also look at. A calculator, papers, and office supplies are on the table.

Description

Learning Objectives

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

Identify good practices and principles for designing effective risk communication messages and tools
Define the current regulatory expectations regarding safety risk communication across the medicinal product lifecycle
Recognize the different types of communication challenges associated with medicinal product risks
Appraise risk communication approaches as an integral component of therapeutic risk management
Outline implementation strategies in the success of risk communication efforts locally, regionally, and globally
Evaluate risk communication strategies for feasibility, effectiveness, and patient-centeredness
List key future trends in safety risk communication

Featured Topics:

Defining “Risk” in the Context of Medicinal Drug Products
What are the Goals of Risk Communication?
Risk Perception and Designing Effective Risk Communication
Successful Risk Communication
Risk Communication and Risk Management in the US and EU
Risk Communication Tools
Who’s Responsible for Communicating Drug Safety Information?
Evaluating Effectiveness of Risk Communication
Effective Presentation of Statistical Risk Information