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AGENDA

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ABOUT THIS EVENT (Hosted by CDER SBIA)

The U.S. Food and Drug Administration (FDA) Biosimilar User Fee Act (BsUFA) III Regulatory Science Pilot program is hosting its second virtual event.

The agenda includes a recap of the activities of regulatory science pilot program from the last engagement that occurred on October 16, 2023. Additionally, the webinar will include a status update on the programs current research portfolio as it relates to the BsUFA III commitments as well as presentations and panel discussions by FDA staff. Lastly, FDA staff will present the next steps planned for the BsUFA III regulatory science program.

INTENDED AUDIENCE

• 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 (BLAs) 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

TOPICS

• 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 next steps
• Stakeholder feedback and discussion on the BsUFA III regulatory science pilot program next steps and ongoing projects

FDA RESOURCES

CONTINUING EDUCATION

Real-time attendance 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.

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.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• Please contact info@sbiaevents.com for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.