DIA 2026 Global Annual Meeting: Full Schedule

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11:00am EDT

#406: Enhancing Regulatory Collaboration through Cloud Technologies

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

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-513-L04-P; CME 1.25; RN 1.25

The session will explore lessons learned and challenges in scaling up cloud-powered regulatory collaborations. It will feature insights from technology providers, regulatory agencies, and industry representatives

Learning Objectives

Explain the value of regulatory collaboration and describe recent technological advancements that enable it; Identify key challenges and opportunities associated with integrating cloud technologies into regulatory processes; Examine perspectives from technology providers, regulators, and industry on the future of regulatory collaboration and outline ways to participate in these efforts.

Chair

Dominique Lagrave, PHARMD

Speaker

Panelist
Marko Eric

Panelist
Julie Lepin, MA

Panelist
Ana Carolina Moreira Marino Araujo

Panelist
Vada Perkins, MS

Speakers

Ana Carolina Moreira Marino Araujo

Head, International Affairs Office, ANVISA, Brazil

Ana Carolina Marino is Head of the International Affairs Office at ANVISA. Holds a permanent position at ANVISA as goverment employe, Health Regulatory Expert, since March 2007. Has experience in both technical and management roles: Advisor at the Fourth Directorate/ANVISA; Head for... Read More →

Marko Eric

Regulatory Assessor, Medicines and Medical Devices Agency of Serbia , Serbia

Marko Eric is a pharmacist. He joined the Medicines and Medical Devices Agency of Serbia (ALIMS) in 2009 at the National Pharmacovigilance Center, where he currently works as the coordinator of the development of the national pharmacovigilance system. In addition to standard PV assessments... Read More →

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States

Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States

Julie Lepin

Senior Vice President & Chief Regulatory Officer, BeOne Medicines, United States

Julie Lepin is a regulatory professional with vast experience across many facets of the profession. She has led numerous major new license applications across many countries, which encompassed scientific advice and advisory committee meetings with multiple health authorities around... Read More →

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum | 08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Cross-Functional Collaboration, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Feature Topics Cross-Functional Collaboration,Digital Enablement and Modernization
Tags Forum

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

#436: Aligning Strategy with Execution: Leveraging Integrated Program Plans, Project, Program, and Portfolio Management, and AI to Advance Drug Development

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

202AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-532-L04-P; CME 1.00; PDU 1.00 PMI 21665YGZQV ; RN 1.00

This seminar shows how life sciences teams can align strategy with execution through integrated program plans, AI-enabled planning, and P3M practices to accelerate time to market, foster innovation, and drive organizational transformation.

Learning Objectives

Distinguish how to align strategy with execution by integrating program plans (IPPs) across R&D, Clinical, CMC, Regulatory, and Commercial Leverage AI-enabled planning and P3M practices to enhance visibility, decision-making, and risk management, accelerating time to market; Discuss ways to adapt leadership approaches to drive organizational transformation, innovation, and compliance in an evolving life sciences landscape.

Chair

Christine Mears, MBA, PMP

Speaker

Aligning Strategy with Execution: Leveraging Integrated Program, Project and Portfolio management with AI to advance drug development
Philip M Zack, DVM, PHD

Panelist
Erin Mulrooney, MSC, PMP

Speakers

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States

Christine Mears

Founder, Lead Consultant, Premiere Consulting Services LLC, United States

Christine M. Mears is an enterprise program, portfolio, and operations executive with 25+ years of experience driving strategy execution and operational performance. Formerly at Eli Lilly in a COO-level capacity, she led global programs, launches, and transformations. As Founder of... Read More →

Erin Mulrooney

Director, Portfolio Analysis & Management, Daiichi Sankyo Co., Ltd., United States

Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →

Philip Zack

Executive Life Sciences Consultant Portfolio, Program and Alliance Management, Self-Employed, United States

Phil Zack has 25 years experience in the biopharmaceutical industry and research. He has held Portfolio, Program and Alliance Management leadership positions within NeXstar, Gilead, Amgen, Vertex, and Myovant Sciences. He has experience in all phases of drug development, in multiple... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session | 07: RegCMC-Product Quality, Session | 02: ClinicalTrialOps-Innovation, Session