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Join the FDA on March 7, 2024 for a comprehensive webinar titled Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes, where industry experts explore the critical aspects of safety analytics for successful FDA submissions.
About the Webinar
Learn the intricacies of planning and executing integrated clinical trial safety analyses crucial for FDA approval. Discover common mistakes to avoid and gain insights on collaboration across various disciplines to ensure accurate integrated analyses.
Intended Audience
This webinar is intended for Pharmaceutical regulatory scientists, clinical reviewers, medical professionals, data scientists, statisticians, and medical writers involved in integrated clinical trial safety analyses.
Key Discussion Points and Learning Objectives
Gain valuable insights into the following critical aspects:
- Early Planning and FDA Engagement: Understand the significance of early planning and learn when to engage with the FDA to discuss integrated safety analysis plans.
- FDA Type C Meetings and Integrated Safety: Explore the issues concerning integrated safety analyses and related data requirements to discuss at FDA Type C meetings.
- Creating Integrated Analysis Sets: Learn how to develop integrated analysis sets for comprehensive safety assessments.
- Analytical Methods and Data Combination: Discover appropriate analytical and statistical methods for combining clinical trial data from multiple studies.
This webinar will equip you with the knowledge to recognize common mistakes, implement best practices, and navigate integrated safety analyses effectively for successful drug marketing applications.
Continuing Education
Upon real-time attendance, earn credits from professional organizations, including RAPS, SOCRA, SQA, and ACRP. Certificates are available post-event for up to two weeks.
Register now and take advantage of this opportunity to enhance your understanding of integrated safety analyses in drug marketing applications.
Please note that an external entity hosts this event.
