Lynne Georgopoulos, RN, MSHS, RAC, is Vice President, Regulatory Strategy, Integrated Drug Development, and Lead of the Pediatric Integrated Practice Area, at Certara. Lynne has over 30 years of diverse biopharmaceutical and CRO industry experience developing and providing strategic guidance and clinical development and regulatory advice at all stages of product development. Lynne has lead numerous successful regulatory filings and agency interactions in the US and Europe with extensive experience in developing and negotiating innovative strategies to accelerate pediatric drug development across multiple therapeutic areas including rare/orphan diseases. Additionally, Lynne has extensive experience in clinical operations and has coordinated large multinational adult and pediatric trials. Previously, Lynne was VP of Regulatory Affairs and Pediatric Strategic Development at Synteract, and Sr. VP Regulatory Affairs and Clinical Development at KinderPharm. Lynne received a nursing degree from Russell Sage College, and a Master of Science in Health Sciences in Regulatory Affairs from The George Washington University. She is regulatory affairs certified through the Regulatory Affairs Professional Society (RAPS) and has published book chapters and articles on pediatric drug development.