Solutions Circles are located in the Exhibit Hall and are designed for small-group collaboration. Each session is limited to 30 participants on a first-come, first-served basis, so arrive early to secure your spot!
Description: Although data suggests that most clinical holds are eventually lifted, the time and cost associated with resolving identified deficiencies can be substantial and is rarely accounted for in project timelines. Experience says that regardless of therapeutic modality or indication, the risk of a hold can often be anticipated and greatly reduced by advancing a regulatory strategy that is equally informed by guidance, regulatory precedent, and core principles like risk management and quality by design. Such a strategy is important not only during the planning, conduct, and presentation of a dossier but also in mitigating a hold’s impact once it has been placed.
This Solution Circle, which follows Wednesday’s session of the same title, will provide engaging discussion that includes each of the core IND disciplines (nonclinical, clinical, and quality) in turn – emphasizing what is needed for a complete application and the value of strategic thinking in the evaluation and mitigation of identified risks. Bring your personal challenges and successes to contribute to this engaging discussion.
Learning Objectives:
Cultivate a reasonable and healthy perspective on clinical holds, including the common causes and outcomes
Understand the importance of engaging with FDA early in development
Attendees will gain perspective from real-world cases
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