DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Advanced

The session will describe informed consent in research participants with cognitive decline, discussing behavioral cues and consent/assent requirements for ethical practices when participants lose the ability to provide informed consent during a study

Learning Objectives

Understand the ethical and operational challenges of engaging participants with cognitive impairment; Describe ethical options for retaining participants with cognitive impairment in clinical trials; Review best practices for informed consent/ caregiver consent/participant assent when the ability to give consent is lost during the course of a trial

Chair

Karla Childers, MS

Component Type: Session
Level: Advanced

Operating models and company’s culture can affect an organization’s value and efficiency. This session will delve into Regulatory Affairs operating models, including opportunities and challenges, providing best practices for your organization.

Learning Objectives

Compare and contrast operating models being used by regulatory affairs organizations that are driving greater value, efficiency, and career empowerment; Understand successes and challenges with different operating models.

Chair

Alison Maloney, PhD, MBA, MS

Component Type: Session
Level: Advanced

This session will offer a comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices. It will explore how regulatory flexibility concerning potency can facilitate and accelerate the development process.

Learning Objectives

Gain Insight into the global regulatory landscape on potency requirement for CGT products; Understand the latest FDA’s guidelines regarding potency testing and industry perspectives; Explore the Role of Surrogate Assays enhancing the overall potency assurance strategy; Learn from Industry Peers: Examine the approaches adopted by members of BIO companies to meet regulatory expectations.

Chair

Lesbeth Caridad Rodriguez, MS

Component Type: Session
Level: Advanced

In this session, we will provide a brief overview of the evolving ICH E20 effort with the goal to provide a transparent and harmonized set of principles for the design, conduct, analysis, and interpretation of adaptive clinical trials.

Learning Objectives

Considerations specific to adaptive design using Bayesian methods will be discussed. Opportunities and challenges of using Bayesian methods in the regulatory setting will also be highlighted.

Chair

Amy Xia, PhD