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Agenda

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ABOUT THIS EVENT

The U.S. Meals and Drug Administration (FDA) is internet hosting a two-part assembly on October 16 (digital) and October 26 (in particular person), 2023.

The assembly agenda contains an summary of the regulatory science pilot program and dialogue of this system’s present standing because it pertains to the BsUFA III commitments. The general public part of the assembly on October 16 may even embrace shows and panel discussions by FDA employees in addition to inner and exterior awardees conducting analysis tasks beneath the BsUFA III regulatory science program. As well as, FDA employees will current updates to the BsUFA III regulatory science program analysis priorities made in response to stakeholder suggestions on the analysis roadmap.

The second day of the assembly might be held in particular person on the FDA White Oak Campus. Throughout this part of the assembly, invitees will take part in spherical desk discussions targeted on progress, suggestions, and suggestions to enhance regulatory influence of the demonstration tasks outlined beneath this system’s analysis priorities.

On account of capability limits, participation within the in-person portion of the assembly might be first come-first served and requires attendance on the webinar part.

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals engaged on scientific, public well being, or coverage points associated to biosimilar organic merchandise or who submit Biologics License Purposes beneath the abbreviated 351(okay) licensure pathway
• Biosimilar product builders
• Researchers engaged on methodologies to advance biosimilar growth
• International regulators working in biosimilar and interchangeable product regulation
• Pharmacists and clinicians
• Sufferers or affected person advocacy teams
• Organic product producers
• Representatives from consortia or different organizations serious about bettering entry to organic merchandise

TOPICS

• BsUFA III regulatory science pilot program overview and standing
• BsUFA III regulatory science pilot program challenge vignettes
• Updates to the BsUFA III regulatory science pilot program analysis priorities
• Stakeholder suggestions and dialogue on regulatory influence of the BsUFA III regulatory science pilot program, ongoing tasks, and updates to the regulatory science roadmap

FDA RESOURCES

CONTINUING EDUCATION

Actual-time attendance to the webinar on October 16, 2023, is required for the certificates of attendance which can be utilized in assist of CEs for the next skilled organizations. Certificates are solely obtainable in the course of the two weeks post-event. No certificates is obtainable for the in-person assembly on October 26, 2023

This course has been pre-approved by:

• RAPS as eligible for a most of 12 credit for a two-day occasion (acceptable to real-time attendance) in the direction of a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in persevering with education schemes for re-certification if this system is relevant to scientific analysis laws, operations or administration, or to the candidate’s scientific analysis therapeutic space.
• SQA as eligible for 1 non-GCP or non-GLP unit for each 1 hour of tutorial time in the direction of a participant’s RQAP re-registration.
• ACRP for persevering with training in scientific analysis. ACRP will present 1 ACRP contact hour for each 45-60 minutes of certified materials.

TECHNICAL INFORMATION

• To optimize your webinar expertise, use Chrome when viewing Adobe Join in a browser.
• Please contact data@sbiaevents.com for all technical questions.
• Should you encounter any technical points earlier than or in the course of the occasion, please go to the Technical Points Assist.
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