Overcoming Disclosure Dilemmas 2023 Edition: Navigating Nuance and Context

Alliance Community conversations, feedback from Section meetings, discussions with accreditors, and the continual addition of accreditor FAQ responses demonstrate that there are practice gaps and educational needs related to navigating the nuances of the Standards for Integrity and Independence in Accredited Continuing Education. This session will focus on three particularly vexing issues: determining whether a company/entity is “eligible” or “ineligible”, whether the content of a certified activity is related to the business lines of an ineligible company, and appropriate methods to mitigate relevant relationships, depending upon the nature of an individual’s relationship and his/her/their role in the activity.

Providers must often be detectives to unravel the nuances of the relationships of potential planners and faculty, particularly when they involve start-up or early-phase drug/biologic/device development organizations. Making informed decisions regarding the relevance of relationships requires an understanding of the therapeutic area, stage(s) of disease, line(s) of therapy, etc. to be included in the planned content, in addition to the context and nuance of planner’s/faculty’s relationships with ineligible organizations.

What resources are useful to help with the decision-making process? How do CPD professionals without a clinical background navigate complex scientific and regulatory scenarios? What questions should be posed to potential planners/faculty to help inform decisions? What role does risk tolerance play in these decisions?  Join us to find out!

During this must-attend session for anyone involved in reviewing disclosures, learners will assess a series of disclosed financial relationships and make determinations to mitigate faculty/planner eligibility based on a variety of factors. After participating in this session, CPD professionals will be better able to:

• Assess the relevance of disclosed financial relationships by investigating their nuances within the context of the planned content


• Evaluate disclosures of potential planners/faculty who have financial relationships with start-up/early phase development organizations based on understanding the development processes and associated regulatory timeline for drugs, biologics, and medical devices

During this highly interactive case-based session, learners will make initial decisions (reported via polling) regarding the relevance of disclosed financial relationships based on varying levels of detail and nuance. After discussion of the case specifics, re-polling will assess learner change.  Learners will also be invited to submit challenging disclosures to the presenters to be included in the session.