Dr. Andrew Chang is a seasoned quality and CMC leader with 28 years in medical product regulation. He serves on the boards of CASSS and PDA. As VP, Regulatory Policy & Intelligence at Novo Nordisk, he leads strategic regulatory and quality initiatives. Since 2013, he has represented Novo Nordisk in industry trade organizations like PhRMA and BIO. Previously, he spent over 11 years at the US FDA, earning awards for regulatory and inspection excellence. He has significant ICH experience, including roles in ICH Q5E, Q12, and Q6 (R1). Andrew holds a Ph.D. in Biochemistry and a BSc in Pharmaceutical Chemistry.