About me
Ingrid Markovic, Ph.D. is Senior Science Advisor for CMC at the FDA's Center for Biologics where she spearheads CMC policy activities partnering with internal and external stakeholders to ensure consistent application of CMC policies and programs. She led FDA efforts for modernization of CMC post-approval reporting categories for complex biologics. Internationally, Ingrid was/is Regulatory Chair for ICH Q6, CBER ICH Quality Lead, FDA co-lead for QDG, M4Q and Q12. She briefly served as Q3E Rapporteur too. Ingrid worked in industry leading US & EU CMC Reg Policy efforts focusing on Manufacturing Innovation and ATMPs. She collaborated with Trade Associations supporting continual improvement and innovation of Biopharmaceutical sector.
