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Post-Symposium Materials

Video recordings, Presentations and Q&A

Introduction & Welcome

  • Patrick Smith, President of Integrated Drug Development at Certara

Keynote – Accelerating Global Pediatric Drug Development – Challenges and Opportunities

  • Lynne P. Yao, Director, Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research (CDER)

Session 1 – Innovative Techniques Toward Extrapolation and Efficient Drug Development

Break (15 min)

Session 2 – Reaching Agreement with Regulators on Global Approach to Pediatric Drug Development

Closing Remarks

  • Lynne Georgopoulos, Vice President, Regulatory Strategy at Certara

Click to view day 1 Q&A

Day 2 Opening Remarks 

  • Patrick Smith, President of Integrated Drug Development at Certara

Session 1 – Neonatal Research Insights

Session 2 – Study Methodologies in Pediatric Trials

Break (15 min)

Session 3 – Multifaceted Approach to Patient Engagement in Pediatric Clinical Research

Closing Remarks

  • Lynne Georgopoulos, Vice President, Regulatory Strategy at Certara

Click to view day 2 Q&A