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  4. BsUFA III Regulatory Science Pilot Program - 10/16/2023
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Event Title
BsUFA III Regulatory Science Pilot Program
October 16, 2023

October 16, 2023
8:30 AM - 12:00 PM ET


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The U.S. Food and Drug Administration (FDA) is hosting a two-part meeting on October 16 (virtual) and October 26 (in person), 2023.

The meeting agenda includes an overview of the regulatory science pilot program and discussion of the program’s current status as it relates to the BsUFA III commitments. The public component of the meeting on October 16 will also include presentations and panel discussions by FDA staff as well as internal and external awardees conducting research projects under the BsUFA III regulatory science program. In addition, FDA staff will present updates to the BsUFA III regulatory science program research priorities made in response to stakeholder feedback on the research roadmap.

The second day of the meeting will be held in person at the FDA White Oak Campus. During this section of the meeting, invitees will participate in round table discussions focused on progress, feedback, and recommendations to improve regulatory impact of the demonstration projects outlined under the program’s research priorities.

Due to capacity limits, participation in the in-person portion of the meeting will be first come-first served and requires attendance at the webinar component.


  • Regulatory science and regulatory affairs professionals working on scientific, public health, or policy issues related to biosimilar biological products or who submit Biologics License Applications under the abbreviated 351(k) licensure pathway
  • Biosimilar product developers
  • Researchers working on methodologies to advance biosimilar development
  • Foreign regulators working in biosimilar and interchangeable product regulation
  • Pharmacists and clinicians
  • Patients or patient advocacy groups
  • Biological product manufacturers
  • Representatives from consortia or other organizations interested in improving access to biological products


  • BsUFA III regulatory science pilot program overview and status
  • BsUFA III regulatory science pilot program project vignettes
  • Updates to the BsUFA III regulatory science pilot program research priorities
  • Stakeholder feedback and discussion on regulatory impact of the BsUFA III regulatory science pilot program, ongoing projects, and updates to the regulatory science roadmap



Real-time attendance to the webinar on October 16, 2023, is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event. No certificate is available for the in-person meeting on October 26, 2023

This course has been pre-approved by:

  • RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.


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