Founder and Principal Consultant
Silver Spring Biopharma Consulting, LLC
Alexandria, Virginia, United States
Youmin was a senior reviewer at US FDA for over 12 years before starting her consulting career in 2022. While at FDA, she reviewed hundreds of drug applications including NDA, ANDA, IND and DMF, participated face-to-face meetings with sponsors and conducted many PAIs.
She was a member of USP expert committees. Before her regulatory career, she was a senior fellow at Novartis and Pharmacia & Upjohn (merged with Pfizer). Currently, she is a principal consultant for biopharmaceutical companies advising on regulatory submissions, all aspects of CMC, and cGMP compliance. She holds a PhD in Pharmaceutical Sciences and BS in Pharmacy.
Disclosure information not submitted.
7 - 3D Printing in Pharma: Regulatory and Compliance Expectations in the Digital Age
Monday, July 14, 2025
3:45 PM - 4:30 PM EDT