Expanding Global Access to Complex Generics: Office of Generic Drugs’ Global Affairs Program Efforts

This session highlights the FDA Office of Generic Drugs’ (OGD) strategic initiatives to enhance global access to complex generics through its Global Affairs Program. It will showcase international collaborations, regulatory science harmonization efforts, and engagement with global regulatory counterparts aimed at addressing access challenges, streamlining development pathways, and promoting regulatory convergence. Attendees will gain insights into OGD’s role in advancing access to high quality, safe and effective generic drugs through transparent communication, shared scientific standards, and cross-border regulatory alignment for complex generic medicines.

Chair:

- Mathew Cherian PhD, VP of Operations & Development, ReVive Biotechnology, Champaign, IL, United States

Co-moderator:

- Qurrotul Aini Shodiquna, Head of Regulatory Affairs, PT Ibu Bumi Sejahtera, Indonesia

Panellist:

- Sarah Ibrahim PhD, Associate Director, Office of Generic Drugs, Food and Drug Administration (FDA), United States