About me
Ingrid Markovic, Ph.D. serves as the CMC Policy Lead in the CBER Office of the Center Director where she spearheads CMC Policy activities partnering with internal and external stakeholders to ensure consistent interpretation and application of CMC policies and programs. In the international arena, Ingrid was/is ICH Quality Lead for CBER, and additionally, FDA topic co-lead for QDG, M4Q and Q12. She had opportunity to briefly serve as Q3E Rapporteur. Ingrid worked in industry leading US & EU CMC Reg Policy efforts focusing on Manufacturing Innovation and Cell & Gene Therapies. She collaborated with Trade Associations (PhRMA & BIO) supporting continual improvement and innovation of Biopharmaceutical sector.
