DIA 2026 Global Annual Meeting: Full Schedule

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10:15am EDT

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

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

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

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 →

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

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 →

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany

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 →

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 →

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

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.

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