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Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
RAPS Focus
RAPS Focus
Networking Opportunity
Networking Opportunity
Ticketed Event
Ticketed Event
Student Focus
Student Focus

Hagit Marchaim, PhD, MBA (she/her/hers)

Owner and principal consultant
HMC-regulation
Aseret, HaDarom, Israel

Hagit is a seasoned regulatory affairs and drug development executive with a robust scientific background and over 20 years of experience in the biotech, pharmaceutical, and combination product industries. Her expertise spans the entire spectrum of drug development, from early-stage research to post-marketing approval.
Hagit has extensive experience in nonclinical and clinical studies, GMP and CMC requirements, and managing meetings with Health Authorities (HAs). She is adept at preparing and submitting regulatory documents to the FDA, EMA, and other global Health Authorities. Her skills include developing regulatory and drug development strategies, conducting gap analyses, and compiling complete registration files.
Currently, Hagit leverages her vast experience as an independent consultant, providing regulatory consultation services to companies, bio-med incubators, and venture capital firms. She offers her expertise either on a permanent basis, leading regulatory affairs activities, or on specific projects.

Presentation(s):

Email Hagit