Generating Clinical Evidence for Pediatric Medical Devices
May 14th, 12:00 pm-1:00 pm ET.
This session will provide crucial insights into the complexities of generating robust clinical evidence for medical devices designed specifically for children.
During this webinar, our expert panel will cover essential topics, including:
- Understanding the Unique Challenges: We’ll explore the specific obstacles encountered when conducting clinical studies in pediatric populations, including ethical considerations, informed consent processes, and the variability in pediatric physiology and development.
- Designing Effective Pediatric Clinical Studies: We’ll delve into best practices for designing clinical studies tailored to children, emphasizing the importance of age-appropriate endpoints, minimizing risks, and optimizing data collection.
- Data Collection and Statistical Analysis for Pediatric Populations: Our panelists will provide guidance on appropriate data collection methods and statistical analysis techniques, considering the unique needs and characteristics of pediatric patients.
- Navigating Regulatory Expectations: We’ll discuss the FDA’s expectations for clinical evidence in pediatric medical device submissions, highlighting the importance of rigorous data and analysis to support safety and effectiveness claims.
- Practical Insights and Q&A: We’ll share real-world examples and host a comprehensive Q&A session to address your specific questions and concerns.
Why Attend?
- Gain a deeper understanding of the challenges and best practices for conducting clinical studies in children.
- Learn how to design effective clinical studies that meet regulatory requirements and ensure patient safety.
- Discover appropriate data collection and statistical analysis techniques for pediatric populations.
- Connect with experts and peers in the pediatric medical device field.
This webinar is essential for anyone involved in developing, testing, or seeking regulatory approval for medical devices intended for pediatric use.