DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate

The ICH improved global drug development, but rising country-specific regulations increase complexity and costs for multinational submissions. This session explores key harmonization challenges, regulatory trends, and strategies to navigate diverse requirements for successful drug approvals.

Learning Objectives

Identify the similarities and differences in how major global regulators (FDA, NMPA, PMDA, EMA) engage with sponsors throughout the drug development lifecycle; Analyze key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways among different regulatory agencies; Gain practical insights into navigating global landscape.

Chair

Steve Sibley, MS

Speaker

After Years of Harmonization, Country Regulations are Diverging and Simultaneous Global Submissions are Becoming Difficult
Steve Sibley, MS

Global Regulatory Communication Practices with Sponsors: A Comparative Analysis
Natalie Tolli, MS, RPh

Component Type: Session
Level: Intermediate

The session explores the transformative impact of the ICH M11 digital protocol template on key clinical trial stakeholders, such as medical writers, standards professionals, and regulatory reviewers. It highlights how standardized, structured content

Learning Objectives

Understand the ICH M11’s Role in Digital Protocols Across Stakeholder Roles; Explore Customization and Multi-View Capabilities; Evaluate the Impact on Decision-Making and Efficiency for Key Roles; Examine Multi-Format Exchange of Protocol Information.

Component Type: Session
Level: Intermediate

This session will explore the evaluation and integration of assistive technology for clinical document content creation. The panelists will describe experimental design, cross-functional team formation, and the adoption of tailored solutions.

Learning Objectives

Evaluate the potential benefits and challenges of implementing assistive technology, including both rule-based and AI-based solutions; Recognize the criticality of working with cross-functional teams to assess and implement technologies, ensuring successful adoption and return on investment; Design a strategy for integrating technologies into existing systems and behaviors.

Chair

Ulrike Kochendoerfer, PhD

Component Type: Session
Level: Intermediate



Learning Objectives

Discuss the unique emotional and professional challenges faced by regulatory writing leaders during periods of significant change; Develop strategies for maintaining personal resilience and emotional well-being while leading teams through industry-wide setbacks and economic pressures; Implement actionable techniques for fostering skill development, reskilling, and collaboration to effectively support both individual and team growth during challenging times

Chair

Robin Whitsell

Component Type: Session
Level: Intermediate

This session will explore the FDA START program for accelerating rare disease therapies. We will invite companies who participated in the START pilot and a FDA representative.

Learning Objectives

Explain the objectives of the FDA START Program and its role in supporting rare disease development; Detail how medical writers can support companies applying for and participating in the START program; Provide an update on the progress of the pilot.

Chair

Robin Whitsell

Component Type: Session
Level: Basic

The ability to find, access, understand, and apply healthcare-related information (health literacy) plays a large role in global health outcomes. This session reviews health literacy and strategies to increase health literacy in a digital age.

Learning Objectives

Understand the basics of health literacy and how they relate to health outcomes; Apply new strategies for communicating healthcare information to a broad audience with a range of health literacy levels; Utilize digital tools to achieve strategic goals around healthcare information dissemination.

Chair

Chantelle Rein-Smith, PhD

Component Type: Session
Level: Intermediate

Following up on 1-year of use with AI and structured content authoring tools. The implementation of these tools, their successes, pitfalls, and metrics. This session is planned to be a follow up to the 2024 presentation.

Learning Objectives

A comprehensive understanding of the successes achieved through one year of using AI and structured content authoring tools in regulatory medical writing processes; Explain pitfalls encountered along the way as well as the presenting relevant metrics for evaluation and future directions for improvement.

Chair

David Meats, II

Speaker

Speakers
Louise Lind Skov, PhD

Speaker
Eishita Agarwal, MSc

Component Type: Forum
Level: Intermediate

This session will cover FDA developments relevant to Medical Affairs activities, including guidance and enforcement on sharing "scientific information about unapproved uses" (SIUU), responding to medical misinformation, and presenting efficacy data.

Learning Objectives

Identify recent FDA policy developments that are relevant to common Medical Affairs activities; Assess potential legal/regulatory risk of current and new Medical Affairs activities in light of these developments.

Chair

Torrey Cope, JD