Attendance an online digital event on Jun. 11, 2024 entitled “Importance of Global Harmonization for Patient Access to Generic Drugs”. The event was offered by International Pharmaceutical Federation (FIP). 

Description: The universal landscape of generic medication improvement and regulation is undergoing notable harmonization impacts driven by the Office of Generic Drugs (OGD, US FDA) and another universal institution to ease global arrival to high quality generic medications. The sessions explained the main objectives and results of these cooperative endeavors, with a concentration on promoting patient arrival to high-quality and affordable generic medications. Three learning objectives appeared from the present discussion.

Learning Objectives:

1. Perception the importance of universal harmonization efforts in improving the regulation and development of generic medications, especially in decreasing cost and time barriers to product improvement.

2. Discovering the function of multi-agency cooperations, represented by the Generic Drug Cluster, in encouraging scientific alignment, data involvement, and quick response mechanisms to identify universal health challenges.

3. Addressing main topics and results discussed through the Generic Drug Cluster, containing improvements in bioequivalence standards, assessment of complex generic manufactures, and cooperative efforts to organize drug approval procedures for critical therapeutic regions.

Moderator:

- Mathew Cherian, VP of Operations & Development, ReVive Biotechnology, United States.

- Nikolina Biskic, Manager Regulatory Affairs, Bayer, Switzerland.

Panellists:

- Sarah Ibrahim PhD, Associate Director, CDER, US FDA, United States.