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Evaluation ViewAttendees 23

Biopharmaceuticals (includes Biologics and Drugs)

Considerations for Global Harmonization and Accelerated Drug Development

Thursday, September 19, 2024
4:30 PM – 5:30 PM PDT
Location/Room: 202
It is critical that sponsors consider efficient and effective strategies to expedite the development of drugs and biologics, especially when developing treatments where there are inadequate or insufficient therapies available. Global harmonization plays a key role in ensuring that these critical treatments are available across multiple regions. Panelists in this session will discuss important opportunities for collaboration, potential regulatory challenges and possible strategies necessary for expediting the availability of increasingly complex and innovative medicines globally.

Learning Objectives:

  • Understand the pathways used to expedite approval of drugs and biologics in major markets
  • Understand the emerging opportunities, including consortiums and special programs across agencies for global harmonization and highlight key considerations and any lessons learned thus far.
  • Incorporate lessons learned from presented case studies.