RN, MSHS, RAC
Clinical & Regulatory Affairs Advisor
Lynne Georgopoulos, RN, MSHS, RAC, is a clinical and regulatory affairs advisor to EDI. Lynne is VP Regulatory Affairs and Pediatric Strategic Development, at Synteract (formerly Sr. VP Clinical Development and Regulatory Affairs at KinderPharm). She has over 28 years of pharmaceutical and biotechnology industry experience in adult and pediatric drug development, across multiple therapeutic areas including dermatology, cardiology, endocrinology, gastroenterology, neurology and rare and orphan diseases.
Lynne has lead numerous successful regulatory filings and agency interactions (Pre-IND, INDs, NDA/BLAs, scientific advice, EOP2, and Pre-NDA) in the US and Europe and had written and/or contributed to over 30 pediatric study plans. Lynne also has extensive
experience in clinical development (adult and pediatric), operations and project management.
Lynne received a Master of Science in Health Sciences in Regulatory Affairs from The George Washington University and is regulatory affairs certified through the Regulatory Affairs Professional Society and is published in the area of global pediatric drug development.