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Wednesday, June 17
 

10:15am EDT

#611: Future of Enhanced Product Development: Enabled Through new ICH Guidelines
Wednesday June 17, 2026 10:15am - 11:30am EDT
111AB
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-606-L04-P; CME 1.25; RN 1.25

This workshop will delve into how the science and risk-based approaches outlined in ICH Q2(2) and Q14 connect to emerging revisions in ICH Q1(R1) and Q6(R1), highlighting their combined impact on product control strategies.

Learning Objectives

Recognize how ICH guideline revisions influence analytical development in the future; Discuss the health authority view on impact that analytical measurements have on the development of the future products; Explain how to apply platform analytical procedures as a follow-up to Workshop 1.

Chair

Timothy Graul, PHD

Speaker

Shifting Analytical Procedure Development from a Reactive Activity into a Proactive, Strategic Pillar of Product Development
Margaret Ruesch, PHD

Shifting Analytical Procedure Development from a Reactive Activity into a Proactive, Strategic Pillar of Product Development
Philip Floyd, PHD

EMA Perspective on Connecting Analytical Procedure Development to Emerging Revisions in ICH Q1(R1) and Q6(R1) and Combined Impact on Product Control Strategies
Peter Richardson

ANVISA Perspective on Connecting Analytical Procedure Development to Emerging Revisions in ICH Q1(R1) and Q6(R1) and Combined Impact on Product Control Strategies
Carolina Lopes Krahn, MSC


Speakers
PF

Philip Floyd

Global Vice President, Analytical R&D, AbbVie, United States
Phil currently serves as Global VP, Analytical R&D within Development Sciences at AbbVie and previously spent 22 years at GSK with last role as Head of US Analytical Development. Phil received his PhD in Analytical Chemistry at U. of Illinois under Jonathan Sweedler, at Beckman Institute... Read More →
TG

Timothy Graul

Senior Director, Pfizer, United States
Timothy W. Graul is a Senior Director in the CMC Advisory Office at Pfizer Inc. He received his B.S. in Chemistry at James Madison University and Ph.D. in Analytical Chemistry at Florida State University. After completing studies, Tim joined Pfizer Analytical R&D and supported the... Read More →
CL

Carolina Lopes Krahn

Health Regulation Specialist, ANVISA, Brazil
Pharmaceutical professional with a degree in Industrial Clinical Pharmacy and a Master’s degree in Pharmaceutical Sciences. Has been working as Health Regulation Expert for Anvisa for over 12 years working as a drug product registration reviewer, quality management professional... Read More →
avatar for Peter Richardson

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands
Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →
MR

Margaret Ruesch

Vice President, Pfizer, United States
Margaret Ruesch is the Vice President of Analytical Research & Development, Biotherapeutics Pharmaceutical Sciences organization. Analytical R&D is responsible for developing in-depth product and process understanding, testing clinical trial materials, authoring investigational and... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Workshop

10:15am EDT

#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice
Wednesday June 17, 2026 10:15am - 11:30am EDT
102AB
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-610-L04-P; CME 1.25; RN 1.25

Randomized clinical trials embedded in routine care—when designed using Quality by Design principles—can generate regulatory-grade evidence that is scientifically rigorous, operationally feasible, and globally harmonized. This workshop will examine how pragmatic and hybrid RCTs can: Align with ICH E6(R3) expectations; Apply selective safety data collection under ICH E19; Incorporate decentralized elements consistent with FDA guidance; Advance FDA’s STEP demonstration objectives Participants will engage in a structured design exercise debating a pragmatic clinical trial in the obesity setting—contrasting a traditional “overbuilt” protocol with a streamlined, embedded alternative. Through moderated discussion, we will identify critical-to-quality factors, risk mitigation strategies, and the regulatory conversations necessary to support global implementation.

Learning Objectives

Apply Quality by Design principles under ICH E6(R3) to pragmatic RCTs in high-impact therapeutic areas; Evaluate where selective safety data collection (ICH E19) may or may not be appropriate in long-term obesity trials; Identify operational and safety risks unique to embedding obesity trials in routine practice—and propose mitigation strategies; Debate the tradeoffs between traditional and streamlined trial designs.

Chair

Kevin Bugin, MS, RAC

Speaker

Panelist
Mary Thanh Hai, MD

Panelist
Henry Wei, MD

Panelist
Zhanna Jumadilova, MD, MBA


Speakers
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory policy and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →
avatar for Mary Thanh Hai

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States
Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the... Read More →
avatar for Zhanna Jumadilova

Zhanna Jumadilova

Clinical Lead, Pfizer, United States
Dr. Jumadilova is a physician scientist, pharmaceutical executive with extensive industry experience in Clinical Development, Medical Affairs, and HEOR. In her roles as a senior leader, she has led numerous development programs. Her diverse experience in both large pharmaceutical... Read More →
HW

Henry Wei

Executive Director, Data, Technology & Innovation, Regeneron Pharmaceuticals, United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
102AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Workshop |   02: ClinicalTrialOps-Innovation, Workshop

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
RE

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 →
RM

Ruri Matsumoto

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

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

4:00pm EDT

#654: India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
116
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-639-L04-P; CME 1.00; RN 1.00

India’s recent regulatory, policy, and digital reforms are accelerating innovation, quality, and global collaboration. This town hall will highlight key updates shaping clinical research, medtech growth, and patient safety, and India’s rising global role.

Learning Objectives

Identify key regulatory, policy, and digital reforms transforming India’s healthcare and innovation ecosystem; Evaluate how updates in clinical trial rules, medical device policy, GMP standards, and data privacy impact global development; Identify opportunities for global collaboration and regulatory convergence enabled by India’s evolving frameworks.

Chair

Vivek Ahuja, MD

Speaker

Panelist
Marc Franklin

Panelist
Shahin Fesharaki

Panelist
Rajeev Singh Raghuvanshi


Speakers
SF

Shahin Fesharaki

Chief Scientific Officer, Lupin, United States
MF

Marc Franklin

CEO - North America, Cipla, United States
avatar for Vivek Ahuja, MD

Vivek Ahuja, MD

Program Chair, Executive Vice President, Pharmacovigilance, EVERSANA, India
Dr. Vivek Ahuja is a physician-turned pharmaceutical leader with 25 years of experience across pharmacovigilance, clinical research, public health, and technology. In 2005 he pioneered pharmacovigilance in India by establishing the first global PV unit at Ranbaxy. He is Executive... Read More →
RS

Rajeev Singh Raghuvanshi

Drug Controller General, Central Drugs Standard Control Organization, India
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   02: ClinicalTrialOps-Innovation, Forum |   07: RegCMC-Product Quality, Forum
 
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DIA 2026 Global Annual Meeting
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102AB
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112AB
114
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Ballroom AB
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Innovation Theater 3
Spark Stage
TBD
Zone A
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  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
  • 06: ProfDevelop-Program-PortfolioMgmt
  • 07: RegCMC-Product Quality
  • 08: RegPolicy-Strategy-GlobalCollaboration
  • 09: RD-Quality-Compliance
  • 10: Stats-EvidenceGeneration-RWE
  • 11: Spark Stage
  • 12: Content-Hubs
  • 13: Community-Rounds
  • 14: Posters
  • 15: Networking-Opportunities
  • 16: InnovationTheaters
  • 17: Short-Courses
  • 18: Lift-Series
  • Audience
  • Advanced
  • Basic
  • Intermediate
  • Area
  • Artificial Intelligence
  • Biotech-ClinTech-Pathway
  • Cross-Functional Collaboration
  • Digital Enablement and Modernization
  • Ethics
  • Evidence Innovation
  • Global Alignment in Practice
  • Patient-Centered Design and Experience
  • Student and Early Career Pathway
  • Therapeutic Pathways
  • Trust and Responsible Innovation