Tina Roecklein MS

Tina Roecklein (a consumer safety officer with FDA/CBER’s office of vaccine research and review in the division of bacterial, parasitic, and allergenic products) provided a US regulatory perspective on the characterization of conjugate vaccines. Glycoconjugates can be very effective at preventing diseases caused by encapsulated bacteria. Their regulatory life should begin in early development and clinical testing stages and extend through post-licensure for as long as such products are on the market. As Roecklein pointed out, characterization is essential throughout that life span.