Safety Risk Communication for Medical Products
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.
This on-demand training course takes an average of 5 hours to complete. Learners have access to the course for one year from the date of purchase.
- 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 is responsible for communicating drug safety information?
- Evaluating effectiveness of risk communication
- Effective presentation of statistical risk information
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
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