Meeting Designed for

• Drug Safety
• Pharmacovigilance
• Risk Management
• Benefit-risk Assessment and Communication
• Medical Product Safety Assessment
• Post-Market Studies
• Real-World Evidence Generation
• Regulatory Affairs
• Clinical Research
• Data Safety Monitoring and Analysis
• Pharmacoepidemiology
• Medical Information
• Medical Communications
• Medical Affairs
• Health Outcomes
• Patient Engagement

Learning Objectives

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

• Describe the new internationally harmonized guidance on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials
• Discuss safety regulatory updates in the U.S, U.K, Europe, Japan, and China
• Recognize MHRA’s progress on updating clinical trial regulations in the UK and its impact on pharmacovigilance activities
• Define FDA draft guidance on the Benefit-Risk Assessment for New Drug and Biological Products for Industry
• Identify new signal detection tools and reinforce the FMQ method and analysis
• Evaluate how regulatory differences impact global risk management organizations and design/implementation of risk minimization materials
• Describe challenges to establishing global approaches to risk minimization and identify risk analysis approaches to developing risk minimization materials
• Analyze recent advances in the use of AI/ML with respect to safety surveillance
• Identify the latest strategies for managing literature requirements at local and global level
• Examine various ways RWE/RWD are utilized in regulatory interactions during clinical development and its role in the evaluation of safety signals arising from clinical trial data
• Explain safety updates and challenges in special population including pregnancy and lactation and transgender population
• Discuss challenges with reaching the minority population and barriers for enrollment in clinical trials and recognize the need for a more inclusive approach within the drug development lifecycle
• Identify potential approaches to address safety challenges in cell and gene therapy and rare disease
• Recognize key concerns smaller companies have encountered with the FDA Final Rule and discuss FDA’s perspective regarding the concerns of smaller pharma companies

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