Current trends and key regulatory consideration for biosimilars

“Regulatory Affairs Certified” RAC (US, EU) Professional and “Certified Clinical Research Associate” (CCRA) with 15 years of experience in Drug/Biologic/Cell and Gene therapies development, Global Regulatory Strategy, Policy, Submissions, and Operations. Expertise in determining non-clinical, Clinical, CMC, and labeling regulatory requirements.

Specialties: Drug Development, Clinical Research, Regulatory Affairs, Regulatory Strategy, NDA submissions, IND submissions, BLA submissions, Business Intelligence, Project Management