DIA 2024 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-547-L04-P; CME 1.00; RN 1.00

This session delves into the latest guidance on real-world data (RWD) and real-world evidence (RWE), offers insights from case studies in which such data were critical for regulatory decisions, and discusses how to prepare the next generation of medical writers for this complex landscape.

Learning Objectives

Analyze the FDA’s current stance and guidance on real-world data (RWD) and real-world evidence (RWE) in regulatory submissions; Compare real-world applications of RWD and RWE, showcased through several case studies; Outline educational strategies for equipping future regulatory and medical writers with the skills and understanding needed to effectively incorporate RWD and RWE into documentation.

Chair

Jeanette Towles, MA

Speaker

Industry Update
Craig Ostroff, PharmD

Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
Tina Schlecht, PharmD, MBA

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-626-L04-P; CME 1.00; RN 1.00

Wondering what a medical affairs team does? This session will dive into some of the different roles within medical affairs, their responsibilities, and how these roles support a product over the course of its development.

Learning Objectives

Recognize how the medical affairs function can support a product across all stages of development; Describe different roles within medical affairs and how they connect to each other and to the broader organization.

Chair

Sejal Vora, PharmD

Speaker

All the Ways Medical Affairs Supports Product Development: Field Perspective
Nital Patel, PharmD, MBA

All the Ways Medical Affairs Supports Product Development: Publication Planning
Wendy Tin, PharmD, RPh

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-639-L04-P; CME 1.00; RN 1.00

Generative AI is gaining traction in trial communications, with goals of expediency and efficiency. New technologies should incorporate patient views and ethical frameworks to keep human interactions that are desirable, necessary, and useful.

Learning Objectives

Describe the ethical framework that encompasses informed consent for clinical research; Evaluate goals for the use of artificial intelligence (AI) in clinical trials and how these goals interact with ethical goals for consent; Discuss how to incorporate patient and participant needs and perspective into AI-assisted clinical trial information and communication.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

Patient Perspective Update
Deborah Collyar

Industry Update
Karla Childers, MS

Industry Update
Catina O'Leary, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-670-L04-P; CME 1.00; RN 1.00

Influencers are community connectors that can be leveraged to expand patient recruitment, particularly for hard-to-engage populations. We will discuss how influencers can engage patient audiences for clinical trial participation.

Learning Objectives

Discuss the power of influencer marketing to improve clinical trial participation, including among diverse populations; Describe how to build an effective influencer campaign — matching the right influencer to your objectives; Develop effective digital assets; Identify how to maximize exposure among a captivated audience.

Chair

Sarah McKeown-Cannon

Speaker

Industry Update
Lara Lane