DIA 2026 Global Annual Meeting: Full Schedule

11:00am EDT

#409: Evolving Role of the Quality Professional: The Future of Professional Development in the Age of AI

Monday June 15, 2026 11:00am - 12:15pm EDT

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-518-L04-P; CME 1.25; PDU 1.25 PMI 216641I1NS; RN 1.25

In this session, we will focus on the evolving role of the quality assurance professional, show you how to manage your professional development as a project, and build skills to deliver measurable outcomes in the age of AI.

Learning Objectives

Recognize the evolving role of the quality assurance professional in the age of AI and how to align with emerging expectation; Apply project management principles to strategically plan and execute your personal upskilling journey in AI; Discuss how to build a personalized career roadmap using practical tools and frameworks to stay relevant, resilient, and future-ready.

Chair

Michael Pelosi, MA, MBA

Speaker

Smarter Roles, Stronger Skills: AI in Workforce Evolution
Haleh Valian, PHD

Compliance to Competence: How AI and New Regulations Are Reshaping the Quality Professional
Jeremy Jones, MS

Quality in the Age of Agents: A Look Back From the AI-Driven Future
Roshan D'Souza

Speakers

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom

Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →

Jeremy Jones

Director, R&D Quality Operations & Excellence, BeOne Medicines, United States

Jeremy Jones is Director of R&D Quality Operations & Excellence at BeOne Medicines, where he leads R&D Quality Operations & Excellence across global research, clinical development, and pharmacovigilance activities. With over 12 years of leadership experience, he specializes in cross-GxP... Read More →

Michael Pelosi

Lead, Quality Assurance, Analytics, Astellas, United States

Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.

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 →

Monday June 15, 2026 11:00am - 12:15pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session | 09: RD-Quality-Compliance, Session

Audience Basic
Area Artificial Intelligence
Level Basic
format csv
Credit Type ACPE, CME, PMI, RN
Interest Area Health Technology & AI,Quality Assurance / Control & CMC
Feature Topics Artificial Intelligence
Tags Session

11:00am EDT

#417: A Holistic Approach to Achieve Fit for Purpose Clinical Trial: Integrating a Function-Agnostic End-to-End Quality by Design and Risk-Based Quality Management Strategy

Monday June 15, 2026 11:00am - 12:15pm EDT

117

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-525-L04-P; CME 1.25; RN 1.25

This session will provide a practical, high-level walk-through of how Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Strategy work synergistically, centered on Critical to Quality (CtQ) factors, demonstrating how to build a unified quality strategy that aligns with regulatory expectations.

Learning Objectives

Recognize CtQ factors using integrated QbD and RBQM in a collaborative, cross-functional setting; Demonstrate the synergistic application of QbD and RBQM across the clinical trial lifecycle; Discuss regulatory expectations and industry best practices for a unified quality strategy; List practical strategies for implementing this approach within organizations.

Chair

Paula Walker, MA

Speaker

Panelist
Mandy Kaur Budwal-Jagait, MSC

Panelist
Paula Walker, MA

Panelist
Sumitra Sachidanandan

Panelist
Cheryl Grandinetti

Speakers

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States

Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →

sumitra_sachidanandan

Regulatory Consultant - GCP Unit, Health Sciences Authority, Singapore

Sumitra is a Regulatory Consultant at the Health Sciences Authority (HSA) in Singapore, heading the GCP Compliance Inspection Unit, which oversees Good Clinical Practice (GCP) inspections and quality improvement for clinical trials. She is the Topic Lead representing HSA at the ICH... Read More →

Paula Walker

Global Head of Risk Based Quality Management, Roche, United Kingdom

Paula Walker is the Global Head of Risk-Based Quality Management (RBQM) at Roche and a member of the Quality Management Leadership team. As former Head of Compliance & Inspectorate at the MHRA, she brings over 13 years of regulatory experience to her mission of accelerating patient... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

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

Audience Intermediate
Area Cross-Functional Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance/Control & CMC
Feature Topics Cross-Functional Collaboration
Tags Forum

2:30pm EDT

#431: Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions

Monday June 15, 2026 2:30pm - 3:30pm EDT

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-528-L04-P; CME 1.00; RN 1.00

Explore patient-focused decentralized trials and direct-to-patient shipments, highlighting their impact on recruitment, retention, and trial performance—and how sites adapt operations to deliver these solutions effectively.

Learning Objectives

Evaluate how DCT solutions and direct-to-patient shipments enhance patient access, recruitment, and retention; Identify best practices for sites to operationalize DCT workflows while ensuring quality and compliance.

Chair

Joan Chambers

Speaker

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Kevin Hudziak, MS

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Becky Suzanne Kottschade, MA, PMP

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Joan Chambers

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Jane Myles

Speakers

Joan Chambers

Independent Senior Consultant, Tufts Center For the Study of Drug Development, United States

With 30+ years in the health and life sciences industry, Joan has led senior initiatives across multiple organizations, specializing in team leadership, strategic planning, integrated marketing, communications, and educational programs for B2B and B2C audiences. She is a Senior Independent... Read More →

Kevin Hudziak

Senior Director - Patient Engagement, Clinical Trial Retention, Eli Lilly and Company, United States

Kevin is Senior Director of Clinical Trial Retention on the Patient Engagement team at Lilly. He has extensive experience gathering patient and site feedback, delivering innovation, and impacting DCT capability development and implementation at Lilly. Kevin has a passion for improving... Read More →

Becky Kottschade

Administrator, Clinical Research, Mayo Clinic, United States

Becky Kottschade is an experienced clinical research administrator. Driven by her commitment to developing innovative options for patients she takes pride in providing the best practices for implementing decentralized capabilities possible. As a research administrator her goals are... Read More →

Jane Myles

VP, Programs and Initiatives, Digital Trials and Research Alliance, United States

Jane has worked in clinical drug development for almost 30 years, starting her career at the bench at Eli Lilly. Over the course of her career she led clinical trials, registrational filing teams, molecular asset decision teams, and eventually led a global function focussed on driving... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

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

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Patient Engagement
Feature Topics Patient-Centered Design and Experience
Tags Forum

2:30pm EDT

#438: A Conversation About Quality: A Global Regulators Discussion

Monday June 15, 2026 2:30pm - 3:30pm EDT

201AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-537-L04-P; CME 1.00; RN 1.00

This forum will present the perspectives of global regulatory agencies on encouraging a high standard for quality in pharmaceutical products. The panel will discuss their vision, key initiatives, challenges on how to improve drug quality worldwide.

Learning Objectives

Describe regulatory agencies’ shared priorities about drug quality in support of a secure, resilient, and high-quality pharmaceutical supply chain; Identify the role of oversight to ensure high-quality pharmaceutical manufacturing; Explain how regulators can work in partnership to reach a coherent, predictable, and efficient global regulatory environment for the benefit of global public health.

Monday June 15, 2026 2:30pm - 3:30pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 09: RD-Quality-Compliance, Forum

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

2:30pm EDT

#443: The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence

Monday June 15, 2026 2:30pm - 3:30pm EDT

117

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-538-L04-P; CME 1.00; RN 1.00

This forum will present Health Authority (HA) expectations related to a robust Culture of Quality focused on Critical-to-Quality (CtQ) issue management. This session will provide specific examples of how leadership commitment and employee ownership enable a robust Quality Culture.

Learning Objectives

Explain Health Authority (HA) expectations of an effective Culture of Quality, specifically around Critical-to-Quality (CtQ) issue surveillance and management; Describe the vital link, and cultural best practices, between leadership commitment, employee ownership, and the ability to effectively manage CtQ issues.

Chair

Michael Torok, PHD

Speaker

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Sameera Ibrahim

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Leslie Sam

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Emily Gebbia, JD

Speakers

Emily Gebbia

Associate Director for Regulatory Development, OC, OSI, CDER, FDA, United States

Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →

Sameera Ibrahim

Head of Risk Governance & Operations, R&D Quality, Bristol Myers Squibb, United Kingdom

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 →

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

Michael Torok, Ph.D., serves as Vice President of Quality Assurance Programs at Roche/Genentech, focusing on de-risking the Development portfolio and accelerating patient access through risk-based quality practices. He leads a global team of Quality Professionals focused on proactive... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Forum

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

4:00pm EDT

#458: Regulatory and Industry Perspectives: Understanding the Significance and Impact of GCP Inspection Observations

Monday June 15, 2026 4:00pm - 5:00pm EDT

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-552-L04-P; CME 1.00; RN 1.00

Explore global GCP inspection outcomes featuring FDA’s 7-year data and international trends, highlighting compliance patterns, regulatory harmonization, and industry strategies for sustaining quality in complex global trials

Learning Objectives

Examine GCP inspection classification and outcomes across regulatory agencies, highlighting similarities and differences in enforcement; Identify common deficiency patterns and regulatory expectations across regions, emphasizing protocol adherence, recordkeeping, and data integrity; Recognize the impact of inspection observations on regulatory decisions; Discuss industry best practices.

Chair

Jenn Sellers, MD

Speaker

Overview of MHRA's GCP Inspections
Rachel Mead

Speakers

Rachel Mead

Senior GCP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Rachel joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a GCP Inspector in July 2019. She conducts a wide range of routine and triggered GCP inspections across both commercial and non commercial organisations, including Phase 1 units registered under the MHRA... Read More →

Jenn Sellers

Chief, GCP Assessment Branch, FDA, United States

Dr. Sellers serves as Chief of the Good Clinical Practice (GCP) Assessment Branch in the Office of Scientific Investigations at the U.S. FDA, where she leads the evaluation of GCP compliance and provides regulatory recommendations in support of marketing applications. She is a board-certified... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

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

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

10:15am EDT

#518: Next Generation Clinical Trial Quality Assurance Using Advanced Analytics

Tuesday June 16, 2026 10:15am - 11:30am EDT

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-567-L04-P; CME 1.25; RN 1.25

See how different pharmaceutical companies use advanced analytics to augment traditional quality assurance methods, hear the Regulators’ perspective on use of innovative quality assurance methods.

Learning Objectives

Identify the different methods that are available to assure the quality of clinical trials that go beyond traditional on-site auditing; Discuss how different companies have applied analytics methods and their impact on clinical trial quality assurance.

Chair

Jennifer Emerson, MPH, RN, PMP

Speaker

Regulators Perspective Next Generation Clinical Trial Quality Assurance Using Advanced Analytics
Rachel Mead

SCORE - Next Generation Clinical Trial Quality Assurance Using Advanced Analytics
Jamie Bridges, MPH

Critical to Quality Assessment Report - Next Generation Clinical Trial Quality Assurance Using Advanced Analytics
Kiernan Trevett, MSC

Panelist
Kavita C. Dada, PHARMD, RAC

Speakers

Jamie Bridges

Executive Director, Clinical Quality Assurance, Merck Sharp & Dohme LLC , United States

Jamie Bridges has 26 years of pharmaceutical experience. She began her career at Pfizer and spent the past 25 years with Merck based out of West Point, PA. Her career has included leadership roles in Data Management, Epidemiology, Operational Excellence and most recently Clinical... Read More →

Kavita Dada

Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States

Captain Kavita Dada, Pharm.D., RAC (US), is Associate Director for Regulatory Operations in the Office of Scientific Investigations, Office of Compliance, at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She provides strategic leadership... Read More →

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany

Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →

Rachel Mead

Senior GCP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Kiernan Trevett

Quality Policy Lead, Genentech, A Member of the Roche Group, United States

Kiernan Trevett is the Quality Policy Chapter Lead in Roche’s R&D Quality function and is responsible for strategic leadership on the shaping of clinical and safety quality policy. Previously, she worked as a GVP Inspector at the UK MHRA for 1O years, with her most recent role being... Read More →

Tuesday June 16, 2026 10:15am - 11:30am 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

1:45pm EDT

#542: Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

117

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-580-L04-P; CME 1.25; RN 1.25

This forum will present: 1) HA expectations related to cross-functional QbD, 2) Specific examples will highlight the change need for traditional clinical trial functions to meet QbD requirements.

Learning Objectives

Explain Health Authority (HA) expectations for cross-functional Quality by Design (QbD); Describe the current state of traditional clinical trial functions and the needed change in those functions to meet HA expectations for QbD.

Chair

Michael Torok, PHD

Speaker

Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?
Jennifer Emerson, MPH, RN, PMP

Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?
Mandy Kaur Budwal-Jagait, MSC

Speakers

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Forum

4:15pm EDT

#561: Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-595-L04-P; CME 1.00; RN 1.00

In this session, we explore the transformative value of integrating AI and advanced analytics into Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) quality assurance, transforming Quality Assurance (QA) from a reactive oversight function to a value-generating enabler for the business and patients.

Learning Objectives

Recognize the value unlocked by the incorporating AI and advanced analytics in GCP/GVP quality assurance; Describe the short and long term transformative benefits; Discuss how to develop strategies for demonstrating the value created by embedding AI and advanced analytics into quality assurance audits.

Chair

Roshan D'Souza

Speaker

Value realisation in augmenting Quality Assurance with advanced analytics & AI?
Frederik Collin, MS

Lessons learned in implementing advanced analytics & AI in Quality Assurance
Jeremy Jones, MS

The Why behind the Value proposition
Roshan D'Souza

Data & Digital: Assessing Measurable Value in QA
Michael Pelosi, MA, MBA

Speakers

Frederik Collin

Senior Data Scientist, Boehringer Ingelheim, Germany

Frederik is a Data Scientist working at Boehringer Ingelheim developing advanced analytics solutions leveraging data in the GCP space. He has co-developed several statistical open-source tools and published scientific articles on quality statistics.

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom

Jeremy Jones

Director, R&D Quality Operations & Excellence, BeOne Medicines, United States

Michael Pelosi

Lead, Quality Assurance, Analytics, Astellas, United States

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 01: ClinSafety-PV-RM, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Health Technology & AI
Feature Topics Artificial Intelligence
Tags Session

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
Tags Session

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

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

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
Interest Area Quality Assurance / Control & CMC
Feature Topics Artificial Intelligence
Tags Session

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

Michael Kuchenreuther

Director Research & Analytics, Numerof & Associates, United States

Mark Twyman

Senior Consultant & Engagement Manager, Numerof & Associates, United States

Wednesday June 17, 2026 4:00pm - 5:15pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 18: Lift-Series, Session

Audience Intermediate
Area Biotech-ClinTech-Pathway
Level Intermediate
format csv
Interest Area Biotechnology & Investors
Feature Topics Biotech-ClinTech-Pathway
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8:00am EDT

#703: How RA/QA Leaders can Optimize AI and Reduce Risk as Industry Moves from the Wild West to its Inevitable Second Phase - Categorization

Thursday June 18, 2026 8:00am - 9:00am EDT

111AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-645-L04-P; CME 1.00; RN 1.00

AI adoption in RA/QA is currently fragmented and uncertain, mirroring earlier technology booms like those of the early 2000s. This session explains why AI will inevitably organize into structured categories and how that shift will reshape decision-making and the marketplace. Executives will gain a clear framework for making confident, risk-aware AI decisions now and as the landscape matures.

Learning Objectives

Analyze the current AI landscape in RA/QA and explain why AI maturity and market structure are inevitable; Differentiate near-term AI actions, deferred investments, and avoidable risks using a category-driven lens; Apply a practical framework to guide compliant, defensible AI decisions across quality and regulatory functions.

Chair

Nicholas Capman, MBA

Speaker

Considerations for AI tool validation and implementation
Benjamin C Eloff, PHD

Pragmatic AI Deployment in RA/QA: Maximizing ROI While Maintaining Human Control
Fatima Sabar, MSC

AI and the Path to Submission Ready RWE: Enabling Compliance and Data Quality
Carrie Nielson, MPH

Speakers

Nicholas Capman

President & CEO, The FDA Group, United States

Nicholas Capman is CEO of The FDA Group, where since 2007 he has led the company’s evolution from a specialized services firm into a service + software organization integrating AI-driven capabilities to strengthen FDA compliance. He is passionate about advancing innovation responsibly... Read More →

Benjamin Eloff

Vice President, Healthcare Innovation Catalysts, United States

Ben Eloff brings nearly 20 years of federal leadership in advancing medical innovation and regulatory science. At FDA, he pioneered the first Bayesian device trial and co-authored the agency’s real-world evidence guidance. He led the launch of public-private initiatives including... Read More →

Carrie Nielson

Director of Epidemiology, Gilead Sciences, United States

Carrie Nielson is a Director of Epidemiology at Gilead Sciences, where she focuses on regulatory policy for RWE and on rigorous observational research methods that support reliable evidence generation. She collaborates with industry, academic, and regulatory colleagues, including... Read More →

Fatima Sabar

CEO, Bluenote Health, United States

Fatima Sabar is the CEO & Founder of Bluenote. Bluenote’s AI Agents Platform for Life Sciences is driving 50-75% efficiency gains for scientists and engineers at the world’s leading biopharma, medical devices and diagnostics companies. The platform focuses on regulatory workflows... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

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

Audience Intermediate
Area Artificial Intelligence, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Regulatory
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
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8:00am EDT

#709: PV Compliance DIY: How to Find and Fix Quality Issues Before They Find You

Thursday June 18, 2026 8:00am - 9:00am EDT

117

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-649-L04-P; CME 1.00; RN 1.00

How do we learn from PV compliance failures? This session will provide insights from across industry and from the regulators on how to identify, prioritise and effectively fix non-compliance in PV, exploring the role of psychological safety in this.

Learning Objectives

Describe how proactive approaches to investigating known issues, using a better understanding of psychological safety and learning from failure can help identify deeper root causes for future proofing compliance within the PV system; Explain how to build a proactive business case for identifying and addressing quality issues within the pharmacovigilance (PV) system and outline practical steps for initiating this work.

Chair

Anna Adams, PHD

Speaker

Panelist
Manny Burga

Panelist
Andrew Cooper

Panelist
Helen Emery

Speakers

Anna Adams

Head, PV QA Europe, Daiichi Sankyo Co., Ltd., United Kingdom

As a senior leader in PVQA at Daiichi Sankyo, Anna is passionate about fostering a strong Quality Culture. Her group manages pharmacovigilance inspection readiness and PV compliance oversight, with transparency and proactive collaboration. She was previously Head of Performance and... Read More →

Manny Burga

Operations Executive, formerly J&J and Kenvue, Independent, United States

Andrew Cooper

Senior Director Business Partnering PV, Regulatory and Medical R&D, GSK, United Kingdom

Helen Emery

Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Helen is a Pharmacovigilance Inspector at the Medicines & Healthcare products Regulatory Agency (MHRA). Prior to joining the MHRA she spent several years in Industry, where she accumulated knowledge across the PV system. She held roles supporting the EU QPPV, which ultimately led... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 01: ClinSafety-PV-RM, Session

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Quality Assurance / Control & CMC
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8:00am EDT

#710: Regulatory and Industry Perspectives on Good Clinical Practice Inspections: Regulatory Approaches, Industry Impact, and Future Harmonization Opportunities

Thursday June 18, 2026 8:00am - 9:00am EDT

107AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-650-L04-P; CME 1.00; RN 1.00

Explore Good Clinical Practice Inspections (GCP) inspections from regulatory and industry views, using FDA data to highlight global trends, compliance strategies, and harmonization, with insights on coverage of sites, sponsors, clinical research organizations (CROs), and regions.

Learning Objectives

Recognize FDA GCP inspection scope and trends from FY2016–2018 across US and non-US sites; Compare inspection approaches among regulators; Evaluate opportunities for harmonization and information sharing; Analyze industry strategies for global inspection readiness and compliance.

Chair

Kassa Ayalew, MD, MPH

Speaker

panelist
Thomas Haag

Panelist
Izumi Oba

Panelist
Jong-Hoon Lee, MD

Speakers

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States

Dr. Kassa Ayalew serves as the Division Director for the Division of Clinical Compliance Evaluation within the Office of Scientific Investigation at the FDA’s Center for Drug Evaluation and Research. In this role, he oversees the evaluation of the integrity of efficacy and safety... Read More →

Thomas Haag

Principal Consultant, Cardinal Solutions Consuting, LLC, United States

Tom Haag has a truly innovative vision for quality in clinical research that is focused on delivering outcome data that justifies therapeutic costs. Formerly the Global Head of Digital Development and Transformation QA with Novartis, Tom led on end-to-end quality and data integrity... Read More →

Jong-Hoon Lee

Senior Physician, FDA, United States

Dr. Lee graduated from University of Virginia (BA; Charlottesville, VA) and Virginia Commonwealth University (MD; Richmond, VA), then completed internship at State University of New York at Syracuse (Internal Medicine; Syracuse, NY), residency at George Washington University (Anatomic... Read More →