ASH | FDA Collaboration: A Workshop on Regulatory Science in Hematology
The 2024 ASH | FDA Collaboration: A Workshop on Regulatory Science in Hematology workshop application is now open.
Apply now
ASH is committed to educating its members on the workings of the U.S. Food and Drug Administration (FDA) and to provide a rigorous understanding of regulatory medicine. Piloted in 2022, ASH and the FDA co-launched a new workshop applicable to future careers in academic medicine with a focus on clinical or translational research, drug development, or regulatory medicine. This program will provide ASH members with a better understanding of the FDA and allow for an exchange of information and contact sharing.
During this two-day workshop ASH members will learn more about the FDA and allow ASH members and Agency representatives to learn from each other. Sessions at the workshop will be presented in several engaging formats that will encourage active participation (e.g., panel format, small roundtables, speed networking with FDA reps).
This workshop will be held in-person at ASH Headquarters in Washington, DC on September 10-11, 2024.
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 [email protected].
Help ASH Build an Inclusive Hematology Community!
ASH is committed to building and nurturing a global hematology community and workforce inclusive of diverse perspectives, talents, and experiences as it works toward one collective goal: helping hematologists conquer blood diseases worldwide.
How Can You Help?
Visit your My Account page, make needed updates to your demographic details, and select your preferred level of ASH access to your information; aggregated or individually identifiable, or choose not to provide or share your information. By sharing information about who you are, you will help ASH have a better appreciation of the diverse needs and talents present in the field, and help to build a more inclusive, collaborative hematology community. It will take only a few moments to complete!
Update Access to Demographic Information Learn About Our Mission