Ingrid Markovic, PhD U.S. FDA

Ingrid Markovic, PhD is Senior Science Advisor in the FDA/CBER Immediate Office of the Center Director, where she is responsible for providing leadership, strategic roadmap and guidance for development, implementation and integration of CMC policies for complex biologics (e.g., Cell&Gene Therapies, Vaccines, Biotech products, etc,). In this role, she is responsible for estabshing key strategic partnerships internally and esternally ensuring consistent interpretation and application of CMC policies across, and between, Centers. In the international arena, Ingrid serves as CBER ICH Quality Lead. She is/was FDA topic lead/co-lead for ICH Q12, QDG, and M4Q. She addirionally briefly served as Q3E Rapporteur and is currently serving as Regulatory Chair for ICHQ6 (Specifications Setting). Prior to her current role, Ingrid worked in the industry sector leading US & EU CMC Regulatory Policy efforts focusing on Technological Innovation and Cell & Gene Therapies. She collaborated with Trades Associations supporting continual improvement and innovation in the Biopharmaceutical sector.