Importance of Global Harmonization for Patient Access to Generic Drugs

The global landscape of generic drug development and regulation is undergoing significant harmonization efforts led by the Office of Generic Drugs (OGD, US FDA) and other international organizations to facilitate global access to high quality generic drugs. The sessions explore the key objectives and outcomes of these collaborative endeavors, with a focus on enhancing patient access to affordable and high-quality generic medicines. Three learning objectives emerge from this discussion.

Moderator:
- Mathew Cherian PhD, VP of Operations & Development ReVive Biotechnolohy, United States

Co-moderator:
- Nikolina Biskic, Regulatory Affairs Manager, Switzerland

Panellist:
- Sarah Ibrahim, Associate Director, CDER, US FDA, USA