DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate

Poor study management, misconduct, and data falsification threaten regulatory decisions on product safety and efficacy. This session will cover regulatory guidelines and case studies of clinical trial electronic systems, risk assessment strategies.

Learning Objectives

Describe regulatory expectations for electronic systems in clinical trials, including electronic health records (EHRs); Examine criteria for evaluating whether these systems are suitable for trials. Discuss methods for identifying and mitigating fraud and misconduct risks in these systems; Understand case studies of fraud and mismanagement to emphasize the need for thorough risk assessments.

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: Intermediate

Overview of risk assessment methodologies used by regulatory authorities to decide on pharmacovigilance inspection planning and frequency including collaborative efforts to learn, develop and collaborate on current processes.

Learning Objectives

Define the methods and risk assessment considerations used by regulatory authorities to decide which entities are subject to pharmacovigilance inspections, including frequency, timelines and inspection type; Recognize the different approaches used among regulators to define risk and apply appropriate assessments and efforts to harmonize processes in future.

Component Type: Session
Level: Intermediate

There is an opportunity to inspire and engage internal stakeholders on the value proposition of the Quality Brief. Sponsors will weigh in on the challenges and opportunities related to the value of the Quality Brief for their internal stakeholders.

Learning Objectives

Understand the internal value proposition for the Quality Brief and its application throughout the QMS and beyond; Apply different tactics to persuade and engage internal stakeholders on the value and application of the Quality Brief.

Chair

Kiernan Trevett, MSc