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ASH | FDA Collaboration: A Workshop on Regulatory Science in Hematology

ASH is committed to educating its members about the U.S. Food and Drug Administration (FDA) and regulatory medicine. Piloted in 2022, ASH and the FDA launched a workshop for those pursuing careers in academic medicine with a focus on clinical or translational research, drug development, or regulatory medicine.

This two-day, in-person workshop at ASH Headquarters in Washington, DC, will feature engaging panel discussions, roundtables, and speed networking with FDA representatives, fostering collaboration and knowledge exchange.

The 2025 ASH | FDA Collaboration: A Workshop on Regulatory Science in Hematology we be held in Washington, DC, on September 29-30, 2025. Applications to take part in the workshop are now open until April 30, 2025.

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ASH FDA meeting attendees

Workshop Goals

At the close of this intimate, multi-day workshop, participants will have a basic knowledge of:

  • The FDA’s role in hematology/oncology product development
  • The Investigational New Drug (IND) process (what an IND is, when an IND is required, and what criteria are used by the FDA to decide if a research study may proceed).
  • Expanded access programs (single patient INDs, emergency INDs, expanded access protocols).
  • Disease-specific considerations (e.g., endpoints in specific diseases, biomarker development).
  • Expedited development programs (e.g., breakthrough therapy designation, fast track designation).
  • Clinical trial design (eligibility criteria, endpoint selection,).

Eligibility Requirements

This workshop is intended for current hematology/oncology fellows, physicians, and researchers. Applicants must have completed at least one year of fellowship training in an accredited U.S. training program and are currently in good standing in their fellowship program. Applicants cannot be employed by a pharmaceutical company or industry.

Application Requirements

A complete application must include a completed application form submitted through the ASH Awards Portal. 

  • Explain why you want to participate in the workshop.
  • What do you hope to learn more about at the Workshop?
  • Are there any specific hematology regulatory topics you would like to see discussed?

Learn More!

Read about the 2022 Workshop in ASH News Daily

Learn about the 2023 Workshop on ASH’s Podcast, The Hematologist

Questions?

For more information, contact Government Relations & Public Health Programs Coordinator Bethany Sheehan at bsheehan@hematology.org.