DIA 2026 Global Annual Meeting: Full Schedule

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10:15am EDT

#616: How to Accelerate Utilization of Decentralized Clinical Trial: What are Issues to Perform Decentralized Clinical Trial?

Wednesday June 17, 2026 10:15am - 11:30am EDT

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-611-L04-P; CME 1.25; RN 1.25

Share the gap of Decentralized Clinical Trial (DCT) regulation in the EU, US and Japan. The speakers also touch how to overcome them. The session is helpful for sponsor which plan the trials.

Learning Objectives

Explain DCT regulations in Japan, the US, and Europe and how to overcome their differences.

Chair

Junko Sato, PHD

Speaker

DCT in Japan
Ruri Matsumoto, RPH

Experiences and expactation to DCT
Rasmus Enggaard, MPHARM, MSC

Speakers

Rasmus Enggaard

Therapy Area Head, CardioRenal/Liver/RareD, Novo Nordisk A/S, United States

Rasmus Enggaard is the Therapy Area Head for CardioRenal, Liver, and Rare Diseases in U.S. Clinical Development & Operations at Novo Nordisk, where he is responsible for execution of a broad and complex clinical trial portfolio. His work focuses on operational excellence, scalable... Read More →

Ruri Matsumoto

Office of Non-clinical and Clinical Compliance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Alignment in Practice
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1:45pm EDT

#637: Destigmatizing 483 Observations

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-627-L04-P; CME 1.00; RN 1.00

Hear from regulators and industry on the challenges and opportunities in supporting sponsors through 483 observations. Panelists will discuss their impact on monitoring strategies and the role that centralized monitoring plays in mitigating violations.

Learning Objectives

Discuss the impact of 483 observations on Risk-Based Quality Management (RBQM) strategies; Describe how perceptions about the criticality of 483 observations are influencing clinical monitoring strategy decisions; Identify opportunities to mitigate anxiety related to 483 observations and to support cohesion between sponsors, CROs, and regulatory agencies to enable future adoption of centralized monitoring strategies.

Chair

Erin Brown, MPH

Speaker

Panelist
Cris McDavid, MS

Panelist
Nicole Stansbury

Panelist
David C. Burrow, JD, PHARMD

Panelist
Tracy Vanderslice

Speakers

Erin Brown

Director, Industry Intelligence and Messaging, Association of Clinical Research Organizations (ACRO), United States

Erin Brown is the Director of Industry Intelligence and Messaging for the Association of Clinical Research Organizations (ACRO), where she leads survey development, collection, and analysis related to risk-based quality management (RBQM) adoption, FDA regulatory trends, and other... Read More →

David Burrow

Director, Office of Scientific Investigations, OC, CDER, FDA, United States

David Burrow is the Director of the Office of Scientific Investigations (OSI) within the Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). He leads CDER's Bioresearch Monitoring (BIMO) program, overseeing clinical... Read More →

Cris McDavid

Senior Director, GCDO, Parexel International, United States

Cris McDavid is a seasoned clinical research leader with over 20 years of global clinical trial delivery experience. Cris leads Parexel Risk-Based Quality Management (RBQM) operations and Integrated Data Delivery (IDD), driving strategic process and technology implementation across... Read More →

Nicole Stansbury

Senior Vice President Global Clinical Operations, Premier Research, United States

Nicole Stansbury, Senior Vice President, Global Clinical Operations, joined Premier research in April 2023 where she has responsibilities covering study start up, site management and monitoring, central monitoring and clinical trial management. Nicole has been a lead for the ACRO... Read More →

Tracy Vanderslice

Vice President, Clinical Operations, Gilead Sciences, United States

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Tags Session

4:00pm EDT

#644: 50,000 Participants, Two Countries, One DCT: Oversight That Worked

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

108A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-630-L04-P; CME 1.00; RN 1.00

50,000 participants across two African countries created oversight challenges no checklist could handle. Learn how operational design and informal KRIs shaped oversight—and dual perspectives from operations and quality.

Learning Objectives

Differentiate traditional monitoring from risk-proportionate oversight in mega-scale DCTs; Analyze how operational practices reflected RBQM and QbD principles without labels; Design fit-for-purpose monitoring approaches informed by informal KRIs and real-time signals.

Chair

Leslie Sam

Speaker

Panelist
Lisa Collins

Speakers

Lisa Collins

Founder - Head Clinical Operations, Innomas Clinical Research (Africa), Nigeria

Lisa Ursella Collins is Co-Founder and CEO of Innomas Clinical Research and a global clinical operations and program leader. She works at the intersection of clinical execution, quality, and operational risk—translating development strategy into disciplined delivery. Through Innomas... Read More →

Leslie Sam

President, Leslie Sam and Associates, LLC, United States

With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 09: RD-Quality-Compliance, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Tags Session

4:00pm EDT

#658: Navigating the Rules of Innovation: Regulatory Expectations for Generative AI Use Cases

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

117

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-641-L04-P; CME 1.00; RN 1.00

This session explores AI's role in pharma, offers regulators' insights and Q&A, introduces a Gen AI validation framework, and showcases use cases in audit report authoring and process/knowledge management chatbot, highlighting ethical, time/cost efficient, and compliant AI adoption.

Learning Objectives

Identify regulatory expectations for implementing Generative AI in the pharmaceutical industry, focusing on practical applications such as structured authoring of audit reports, Generative AI validation frameworks, and AI-powered chatbots for knowledge management; Discuss the challenges, user experiences, cost efficiency, and compliance considerations involved in integrating AI into regulated environments.

Chair

Oliver Fink, MS

Speaker

Framework for computer system validation of Gen AI
Haleh Valian, PHD

Regulators expecatations and insights into Gen AI
Karen Bleich, MD

Gen AI-powered structured authoring for audit reports
Srilatha Endabetla, MS

Speakers

Karen Bleich

Lead Physician, OMP, CDER, FDA, United States

Dr. Bleich is a Lead Physician in the Division of Clinical Trial Quality and a member of the AI team within the Office of Medical Policy (OMP), CDER, FDA. In these roles, she drives clinical research quality and innovation through the development of medical policy programs and strategic... Read More →

Srilatha Endabetla

Senior Director, Business Intelligence - Global Quality, Bristol Myers Squibb, United States

Srilatha Endabetla is a senior leader driving Business Intelligence and Digital & Data Strategies for Global Quality, with over 30 years of experience in digital transformation, data analytics, and data governance in the pharmaceutical industry. She has spent 23 years at Bristol Myers... Read More →

Oliver Fink

Head Learning, Processes and Digitalization, Boehringer Ingelheim, Germany

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States

Dr. Haleh Valian is a data-driven executive leader with nearly three decades of experience spanning biotechnology, healthcare, finance, and advanced analytics. She is currently the Director of R&D Decision Quality Analytics and Innovation at Biogen, where she leads the strategic transformation... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 03: Data-Tech-AI, Session

Audience Basic
Area Artificial Intelligence
Level Basic
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence
Interest Area Quality Assurance / Control & CMC
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4:00pm EDT

#657: Great Science Isn’t Enough: Building Value Early in Emerging Biotech

Wednesday June 17, 2026 4:00pm - 5:15pm EDT

103A

Component Type: Session
Level: Intermediate

As a closing session, this discussion brings together key themes from the day to examine how innovators can better connect science to market realities. It will highlight practical ways to optimize product value for investors, payers, and regulators

Learning Objectives

Understand the factors that shape product value; Identify critical early decisions (indication, endpoints, evidence) that influence downstream access and partnering outcomes; Define opportunities to better align development strategy with payer, provider, and investor expectations.

Chair

Mark Twyman

Speaker

Panelist
Michael Kuchenreuther

Speakers