Signature Series Session

ICH E6 changes are upon us. Are you ready to implement new expectations for Good Clinical Practice (GCP) and a flexible framework for clinical trial design and conduct? Please join us for a panel discussion on the principles described within ICH E6(R3), the changes from ICH E6(R2), the implications for GCP, considerations for implementation, and insights on how we as an industry can think through flexible design in a quality-minded environment. This is a session you will not want to miss. 

CEU: 1.00 ACRP

Speaker:

• Kassa Ayalew, MD, MPH, Director, Division of Clinical Compliance Evaluation, Office of Scientific Investigation, Center for Drug Evaluation and Research (CDER), U.S. Food & Drug Administration (FDA)

• Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor, The Ohio State University

• Katherine Mary Marangio, Learning Program Consultant, Parexel

• Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC

Watch the Webinar Replay Ahead of the Live Session (Free Without Contact Hours):

• Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3)

Related Blog Content:

• The Impact of ICH E6(R3) on GCP: Implementing New Expectations in a Culture of Quality

Related Resource:

The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.

Signature Series Keynote Session

Artist, resilience expert, burn survivor, entrepreneur, and inspirational storyteller, Allison Massari knows first-hand the healing power of compassion. In this inspiring session, hear how you can be the remedy with simple acts of kindness that take seconds. Leave with actionable insights and ways to incorporate compassionate care into your clinical research practice.

Speaker:

• Allison Massari, Interdisciplinary Artist, Executive Coach, Entrepreneur

Related Blog Content:

• Delivering Compassionate Care Can Transform Lives in Clinical Research

Related Event:

• Keynote Speaker Meet & Greet

Signature Series Session

Join Dr. David Burrow from FDA's Center for Drug Evaluation and Research as he explores operational strategies for implementing Quality by Design and the integration of Risk Based Quality Management Systems into routine trial design and conduct. Dr. Burrow will build on the key themes discussed in his 2024 Signature Series presentation titled, “Reimagining Clinical Research: The Transformation of Trial Design & Conduct” and bring his own unique perspectives to the next stage of reimagining clinical research and removing barriers to innovation. Take away practical approaches to mitigating obstacles, advancing the shared interests of human subject protection, generating high quality evidence of safety and effectiveness, and enabling action through strategies to manage fear - both as an organization and as an individual. 

Objectives: 

1. Discuss key themes of Quality by Design, Critical to Quality factors, and Risk Based Quality Management Systems. 

2. Advance shared understanding of the CDER Center for Clinical Trial Innovation (C3TI) and other FDA drug development programs.  

3. Provide strategies to advance innovation and enhance quality while also minimizing fear of regulatory oversight. 

CEU: 1.00 ACRP

Speaker:

• David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Related Blog Content:

• Mitigating FEAR in Clinical Research Innovation: ‘Face Everything And Rise’ Together!

Signature Series Session

Meaningful change can come from the top down and the ground up—but in clinical research, valuable perspectives from seasoned professionals in the field have been silent for too long. This session builds on an NIH survey that was first examined at ACRP 2024 and then expanded upon in a pioneering national survey by ACRP and Continuum Clinical in December 2024 with the goal of understanding how to improve clinical trials from those who implement and manage trials.

Through the lens of transformation, this survey goes beyond the barriers that are typically captured to explore real-world actionable insights for clinical trial implementation, our current state, where do we want to go from here, and the changes needed to reach an ideal future state.

Come hear wisdom gathered from clinical research professionals just like yourself--and share your voice in this lively discussion! Our speakers will share the survey insights and propose practical, solutions-based approaches to overcome the reported barriers. All ACRP 2025 registrants will receive exclusive access to a pre-read document before the conference to help set the stage for the discussion in New Orleans.

Join us for this engaging session to discover actionable solutions to the issues that hinder successful clinical trials. Your colleagues (and hopefully, you!) have spoken, so don't miss out!

CEU: 1.00 ACRP

Speakers:

• Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah

• David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

• Paul Ivsin, Executive Vice President, Trial Engagement Service, Continuum Clinical

• Edwina McNeill-Simaan, EdD, MSHS, CCRC, CCRP, Program Director, Vanderbilt University Medical Center

• Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc

• Pamela Tenaerts, MD, Chief Scientific Officer, Medable

Leadership & Professionalism Journey Sponsor

Signature Series Session

Artificial Intelligence (AI) is on the loose, but don't panic – instead, join us for a panel discussion that offers a scenic tour of the work of AI. We will start the journey with an introduction to the basics of what AI is and how it is being implemented into clinical research. Our panelists will then steer us toward critical talking points regarding the responsible use of AI and how we can navigate this journey together as we move to embrace its many applications in clinical research. ​

Objectives:

• Describe the components of AI ​

• Explain the current role of AI in clinical research ​

• Discuss responsible use of AI ​

• Discuss how the clinical research industry (including patients) can benefit from AI now and in the future​.

CEU: 1.00 ACRP

Speakers:

• Noelle Gaskill, MBA, ACRP-CP, VP, GM of Time Network, Tempus

• Lisa Moneymaker, Head of Strategic Customer Engagement, Medidata Solutions

• Pamela Tenaerts, MD, Chief Scientific Officer, Medable

• David Vulcano, LCSW, MBA, CIP, RAC, FACRP, VP Clinical Research Compliance & Integrity, HCA Healthcare

Related Blog Content:

• Ready or Not, it’s Time to Take AI in Clinical Research Seriously