Assessing the abuse liability of investigational drugs remains one of the more complex and nuanced areas of drug development and regulatory strategy. Sponsors frequently face challenges understanding the full scope of regulatory expectations, determining appropriate nonclinical and clinical assessment approaches, and ensuring that abuse liability considerations are adequately addressed at the time of regulatory submission.
This presentation will provide a practical and strategic overview of abuse liability assessment from both nonclinical and clinical perspectives. Drawing on extensive experience working with the FDA's Controlled Substance Staff (CSS) and participation in the Cross Company Abuse Liability Council (CCALC), an industry collaborative that has engaged in ongoing dialogue with FDA since 2006, the speaker will share insights gained through years of industry-regulator interaction, including contributions to discussions surrounding FDA's abuse potential assessment framework.
Topics will include:
- The regulatory purpose and importance of abuse liability assessment.
- Key nonclinical and clinical evaluation components.
- Common sponsor misconceptions and regulatory pitfalls.
- Expectations for supporting scheduling evaluations and regulatory filings.
- Strategic considerations for planning abuse liability programs early in development.
- Lessons learned from industry-FDA dialogue and evolving regulatory practices.
Location
Carnegie Library of Pittsburgh South Side
2205 E Carson St
Pittsburgh, PA 15203
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speaker
Beatriz Rocha
