DIA 2026 Global Annual Meeting: Full Schedule

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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
Feature Topics Artificial Intelligence
Interest Area Health Technology & AI,Quality Assurance / Control & CMC
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
Feature Topics Cross-Functional Collaboration
Interest Area Quality Assurance/Control & CMC
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
Feature Topics Patient-Centered Design and Experience
Interest Area Patient Engagement
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

DIA 2026 Global Annual Meeting

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DIA 2026 Global Annual Meeting

11:00am EDT

Roshan D'Souza

Jeremy Jones

Michael Pelosi

Haleh Valian

11:00am EDT

Mandy Budwal-Jagait

Cheryl Grandinetti

sumitra_sachidanandan

Paula Walker

2:30pm EDT

Joan Chambers

Kevin Hudziak

Becky Kottschade

Jane Myles

2:30pm EDT

2:30pm EDT

Emily Gebbia

Sameera Ibrahim

Leslie Sam

Michael Torok

4:00pm EDT

Rachel Mead

Jenn Sellers

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