Dr. Gül Erdemli is a Global Program Regulatory Director at Novartis, Early Development Regulatory Affairs. She is a drug development leader with more than 15 years of industry experience, from target identification to clinical development. Dr. Erdemli is a Diplomate of American Board of Toxicology and holds Regulatory Affairs Certifications for the US and EU. She has experience in small molecule biologics, gene therapy clinical development, and regulatory validation and qualification of novel digital outcome assessments. In her current role at Novartis, Dr. Erdemli is responsible for providing global strategic and operational regulatory direction in multiple drug development programs. She is also responsible for providing global strategic and operational regulatory direction for two international consortiums funded by Innovative Medicines Initiatives to qualify digital clinical outcome measures for regulatory and clinical endorsement. Dr. Erdemli has an MD from Hacettepe University Medical School and a PhD in Pharmacology from Hacettepe University.