DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Basic

This session explores adverse event collection, processing, and actioning fundamentals as critical for integrating patient safety within teams, organizations, and the broader clinical research and patient care ecosystems.

Learning Objectives

Propose improvements within the drug safety landscape to adverse event reporting, processing, decision-making, and communication; Appraise stakeholder roles in protecting patients and promoting public health; Discuss opportunities for adverse event stakeholders to collaborate across the health care continuum (clinical development, safety, advocacy) to converge clinical research and clinical ca

Chair

Allison Cuff Shimooka, MBA

Component Type: Session
Level: Basic

This session will provide an update on recent industry initiatives to transform towards a data-centric protocol, demonstrate real use cases leveraging digital protocol information, and share thoughts on how to prepare for the change required.

Learning Objectives

Understand how various digital protocol collaborations are working together including ICH M11, Transcelerate/CDISC Digital Data Flow, and the HL7 Vulcan Unified Digital Protocol; Demonstrate the digital protocol in action from design through regulatory review; Prepare for the implementation and change management required to realize the benefits of a digital protocol.

Chair

Chris Decker, MS

Speaker

Transforming the Study Protocol from a Document-Centric to a Data-Centric World to Enable AI, Drive Automation, and Design Be
Chris Decker, MS

Preparing for ICH M11: Am I Prepared?
Robert DiCicco, PharmD

Component Type: Session
Level: Basic

Single Arm Trials (SATs) are an important tool for drug development. The session while focusing on EMA and FDA guidance documents on SATs, will discuss how external information can support the needs and expectations of regulators and HTA globally.

Learning Objectives

Identify the appropriate settings and considerations for using external evidence in designing single-arm trials; Discuss strategies for advancing global drug development with single-arm trials, addressing differing perspectives among regulators and between regulators and HTA representatives.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Component Type: Forum
Level: Basic

This panel will discuss whether flexible operational approaches like decentralization, embedding trials in clinical practice, and allowing setting adjustments will affect data quality. Real and perceived impediments to data quality will be explored.

Learning Objectives

Identify flexible trial approaches and their benefits and limitations; Assess when flexible trial approaches may impede data quality; Discuss solutions for maintaining data quality.

Chair

Lindsay Kehoe, MS

Component Type: Session
Level: Basic

This interactive workshop designed by a behavioral scientist from Tufts CSDD will provide an experiential learning experience covering levers that can enhance leadership effectiveness using an inclusive leader framework.

Learning Objectives

Identify specific inclusive leadership behaviors that can enhance individual and team-level outcomes; Learn about the challenges and barriers associated with inclusive leadership practices; Discuss evidence-based ways to practice inclusive leadership that resonate with all employees.

Chair

Jennifer Kim, PhD

Speaker

What's Next for Developing Inclusive Leaders? 
Christine Mayer-Nicolai, PharmD

Challenges of Leading Inclusively in Cross-Functional, Mixed Teams
Tamei Elliott, MS

Component Type: Session
Level: Basic

This session will discuss the challenges in safety surveillance for medical devices relating to incident capture, data standards and terminologies. Looking at the impact on signal detection and how these barriers can be overcome to improve patient safety.

Learning Objectives

Describe challenges and barriers in the capture of adverse incident data for medical devices; Discuss novel approaches to enhance signal detection for medical devices; Assess opportunities for better ways of working across different stakeholders in device vigilance activities.

Component Type: Session
Level: Basic

This session aims to explore the potential, innovative and safe applications of these technologies in the realm of drug and medical device development, featuring speakers from health authorities, academia and/or industry.

Learning Objectives

Describe what synthetic data and digital twins are; Apply AI to generate synthetic data and digital twin; Illustrate the potential of synthetic data and digital twins in medical product development.

Chair

Di Zhang, PhD

Component Type: Forum
Level: Basic

This panel discussion will offer valuable insights and practical strategies for organizations looking to implement or refine mentorship programs that drive professional development, organizational cohesion, and a culture of continuous learning.

Learning Objectives

Analyze how mentorship reduces silos and evaluate its impact on engagement, retention, and growth; Learn how to assure success of mentoring programs through clear roles and responsibilities; Illustrate examples fostering collaboration; Summarize mentorship evolution via success stories; Differentiate reverse mentorship's role in reducing hierarchies.

Chair

Carol Morales