Who should attend?

Professionals with intermediate to advanced knowledge of, and experience in, clinical safety and who are involved in:

• Drug safety/ Pharmacovigilance
• Risk management, including Risk Evaluation and Mitigation Strategies (REMS)
• Benefit-risk assessment and communication
• Medical product safety assessment
• Post-market studies and Real-world evidence generation
• Regulatory affairs
• Clinical research
• Data safety monitoring and analysis
• Pharmacoepidemiology
• Medical information, Medical Communications, Medical Affairs
• Health outcomes
• Customer Engagement Programs, including Patient Support Programs

It is also designed for professionals who work in the settings of:

• Industry: pharmaceuticals and biologics
• Clinical Research Organizations
• Academic Research Centers
• Regulatory Agencies

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

• Describe the requirements for the use, management, and documentation of the reference safety information (RSI) in clinical trials and how they are enforced by regulatory agencies
• Identify the key descriptive and analytical statistics, their use in interpreting measures of risk, and how estimands can be applied to safety analyses
• Analyze, implement pharmacovigilance inspection preparedness
• Discuss the factors which predict susceptibility to believe misinformation and identify potential interventions to reduce the sharing of misinformation
• Outline the key principles and skills necessary for an effective communication strategy
• Examine the complexities in management of sudden peaks and unprecedented volume of adverse events, discover solutions to deal with sudden peaks in volumes
• Discuss current-state and potential future applications of AI in PV as well as the regulatory challenges and implications
• Recognize challenges and opportunities that occur in prospective pregnancy registries and bring to understanding drug safety during pregnancy
• Integrate RMP and REMS regulatory update information into work practices