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Importance of Global Harmonization for Patient Access to Generic Drugs

11 June 2024

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.

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

- Nikolina Biskic, Regulatory Affairs Manager, Switzerland

- Sarah Ibrahim, Associate DirectorCDER, US FDA, USA