• Gain the ability to evaluate risk communication approaches across the medicinal product lifecycle in light of scientific ‘good practices’ and emerging evidence.
• Understand the opportunities for enhancing the effectiveness of safety risk communication in light of evolving regulatory expectations.
• Leave with cutting edge, patient-centered solutions for safety risk communication and risk management strategies.
  

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
• Describe 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
• Demonstrate an awareness of risk communication as an integral component of therapeutic risk management
• Discuss the role of implementation in the success of risk communication efforts locally, regionally, and globally
• Evaluate risk communication strategies for feasibility, effectiveness, and patient-centeredness
• Name key future trends in safety risk communication