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Type: 08: RD-Quality-Compliance clear filter
Tuesday, June 10
 

9:30am EDT

21A: Risk-Based Quality Management in Action: Hands-On with a Real Study Protocol
Tuesday June 10, 2025 9:30am - 12:30pm EDT
TBD
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-502-L04-P; CME 2.75; IACET 2.75; RN 2.75

Pre-registration required and is an additional fee.

Already registered? Log in to DIA's My Account My Events.

This Short Course will be offered virtually – Join from anywhere!In this short course, participants will gain hands-on experience in applying Risk-Based Quality Management (RBQM) principles, grounded in the Quality by Design (QbD) framework, to real-world clinical trial scenarios. Working in small groups, participants will analyze a three-page real-life study synopsis, using guidance from ICH E6(R2/R3), to identify critical data, critical processes, and potential risks. Following an instructor-led introduction to key concepts like risk scoring and mitigation strategies, participants will identify and prioritize risks, create actionable risk statements, develop mitigation plans, define Key Risk Indicators (KRIs), and establish Quality Tolerance Limits (QTLs).With feedback from expert instructors, participants will refine their critical thinking and learn how to distinguish key data and processes in clinical trials. This approach emphasizes practical relevance, equipping attendees with tools to apply RBQM and QbD principles to their own protocols immediately. Through collaborative group work and actionable insights, attendees will leave with a clear understanding of how to embed ICH E6(R3)-aligned QbD strategies into their risk management practices.

Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.
Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Who should attend?

Professionals involved in or interested in clinical research, particularly risk managers, project managers, study managers, clinical data managers, statisticians, lead monitors, auditors, and those involved in risk-based quality management and risk-based monitoring activities.

Learning Objectives

  • Identify critical data and critical processes, determine the risks and define a risk statement
  • Evaluate the risks regarding likelihood, impact and detectability, and define suitable mitigation actions, KRIs and QTLs
  • Evaluate compliance with ICH E6 R2/R3 and increase the potential for study success


Speakers
JN

Julien Nunes Goncalves

RBQM Solutions Architect, Cyntegrity, South Africa
avatar for Johann Proeve

Johann Proeve

Chief Scientific Officer, Cyntegrity
He studied agro-biology and started his business life in 1980 at Bayer in Clinical Data Management. Between 1990 and 1994 he had been Head of Clinical Data Management at Bayer Corp in West Haven, Connecticut, USA. Since 2000 he had been the Head Global Data Management at Bayer Healthcare... Read More →
Tuesday June 10, 2025 9:30am - 12:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
 
Sunday, June 15
 

9:00am EDT

61F: Root Cause Analysis and CAPA Management: Your Essential Toolkit for Best Practices
Sunday June 15, 2025 9:00am - 5:00pm EDT
TBD
Component Type: Tutorial
CE: ACPE 7.50 Application UAN: 0286-0000-25-508-L04-P; CME 7.50; RN 7.50

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account/ My Events. According to the FDA (as well as other regulators), corrective and preventive action (CAPA) management and lack of proper investigation of challenges is a top observation among companies in the industry. In this short course, through interactive case studies, participants will learn how to conduct a proper investigation into a robust root cause analysis using industry standard tools in a toolkit approach. Additionally, participants will explore the challenges of proper CAPA planning and define appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. Real-life case studies from various FDA 483s will be explored to showcase how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Who should attend?

Professionals who want a better understanding of how to perform a robust root cause analysis and CAPA plan to shift from a reactive organization to a proactive organization. This workshop is best suited for those in regulated industries in various industry areas such as quality, regulatory, operations/production, laboratories, etc.

Learning Objectives

  • Determine the best approach to train individuals on industry best practices in CAPA management
  • Utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and effectiveness checks to ensure compliance and remediation of observations
  • Analyze case studies for techniques and strategies that will help solidify how to use the different tools


Speakers
avatar for Christy Mazzarisi

Christy Mazzarisi

Associate Director, Development Operations, Q&C/CTD, Kinapse
Accomplished Quality Systems Professional with a broad background in Pharmaceutical and Laboratory sciences with R&D and commercial manufacturing (sterile and non-sterile) experience with 15 years industry practice. Overall background and specialties include GMP and GLP; which has... Read More →
avatar for Danielle Metzger

Danielle Metzger

Principal Quality Consultant, PharmaQ Consulting, United States
Accomplished Quality Professional with a broad background in pharmaceutical life sciences having R&D through commercial experience with 25 years of practice in Quality & Manufacturing, global consulting, and business development. Experienced and well versed in GMP and have working... Read More →
Sunday June 15, 2025 9:00am - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Tutorial |   20: Short-Courses, Tutorial
 
Monday, June 16
 

11:00am EDT

Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

This forum will discuss Good Clinical Practice (GCP) inspection methods, collaboration and training among regulators and their inspectors as they respond to the evolving clinical trial regulatory landscape such as the implementation of ICH E6 R3 and novel trial methodologies

Learning Objectives

Examine the reasons why regulators may inspect clinical trials in different ways; Compare the various inspection approaches used by different regulators; Explain how regulators are harmonizing inspection approaches and collaborating to share information, resources, and training; Analyze how regulators are preparing to implement ICH E6 R3 and its implications for inspections and inspector training.

Speakers
avatar for Mandy Budwal-Jagait

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 →
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum

2:15pm EDT

Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Intermediate

This forum will present: HA expectations related to QbD, RBQM, and issue management, Specific examples of how study teams use technology to overcome challenges in achieving QbD and effective RBQM and issue management practices.

Learning Objectives

Understand Health Authority (HA) expectations when designing and executing clinical studies, specifically for using risk proportionate approaches in Quality by Design (QbD), Risk Based Quality Management (RBQM) and issue management practices; Describe real life examples of technologies that facilitate the achievement of HA expectations for QbD, RBQM, and issue management.

Chair

Michael Torok, PhD

Speakers
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group
Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

3:45pm EDT

Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

This session will cover the different ways clinical trials can be operationalized in clinical care, the benefits and challenges of the various approaches, and the applicability of good clinical practice requirements to them.

Learning Objectives

Describe key elements of the design and conduct of trials integrated into clinical care; Outline the various operational approaches for such trials, including the benefits and challenges; Discuss the applicability of good clinical practice requirements to various operational approaches.

Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session
 
Tuesday, June 17
 

8:30am EDT

Alphabet Soup: Utilization of Quality-by-Design and Risk-Based Quality Management in Clinical Trials Data Governance - A Multi-Regulator Inspection Perspective
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Advanced

This session covers the importance of the trial risk assessment process, change control implementation and presents case studies from multiple regulators where effective RBQM could have helped prevent significant GCP non compliances for eSystems/DHTs

Learning Objectives

Discuss QbD and critical to quality factors for data reliability and participant safety in clinical trials including requirements in ICH E6 R3; Understand the importance of change control and risk assessment for data governance and eSystems/ DHTs; Learn from regulatory inspection and compliance case studies from multiple regulators; Identify routine GCP inspection requests.

Speakers
avatar for Mandy Budwal-Jagait

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 →
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

10:30am EDT

FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Effective data management and risk mitigation are crucial for ensuring data quality, safety, and reliability. This session explores strategies to uphold these standards in cutting-edge trials.

Learning Objectives

Outline regulatory requirements for data quality, traceability, and reliability in trials with decentralized elements, adaptive designs, and RWD; Discuss case studies with complex data flows to highlight to he importance of understanding data flow, conducting risk conducting risk assessments, and applying effective risk mitigation strategies.

Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

1:45pm EDT

Embracing ICH E6(R3) with Risk-Based Quality Management and Data Governance
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Through use cases and maturity models, this session will focus on strategies and barriers to integrating RBQM and data governance in clinical trials.

Learning Objectives

Interpret key changes in ICH E6(R3) regarding RBQM and data governance; Implement key principles, components, and change management strategies for RBQM; Assess and benchmark organizational adoption of RBQM components.

Chair

Madeleine Whitehead

Speaker

New and Expanded Assessment of Risk-Based Quality Manangemnt Adoption: Assessing Implementation Progress and Impactased
Abigail Dirks, MS

Navigating the Future of Clinical Trials: Embracing ICH E6(R3) with Risk-Based Quality Management and Data Governance 
Anina Adelfio


Speakers
MW

Madeleine Whitehead

RBQM CoE - Head, Roche, United Kingdom
Madeleine Whitehead is the Head of Strategic Leads in the RBQM Centre of Excellence at Roche Pharmaceuticals. During her nearly 20 year career in the industry, she has worked in both pharma and CROs as a process and Good Clinical Practice (GCP) specialist. With a robust background... Read More →
AD

Abigail Dirks

Data Scientist, Tufts CSDD, United States
Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site... Read More →
AA

Anina Adelfio

Vice President, Industry Relations, Association of Clinical Research Organizations (ACRO), United States
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

4:00pm EDT

Pharmacovigilance Inspector Fireside Chat
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

A rare opportunity to hear inspectors from three global regulators compare and contrast common compliance trends, hot topics, legislative updates, future conduct of inspections, and global collaboration efforts.

Learning Objectives

Distinguish commonalities and differences between pharmacovigilance regulations and inspections undertaken by three global regulators; Discuss common trends from inspection deficiencies identified by the three regulators and gain tips on improving compliance; Define areas of future direction for inspections and collaboration efforts in pharmacovigilance inspections globally.

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum

4:00pm EDT

Updated Tufts Center for the Study of Drug Development Benchmarks on Vendor Qualification Practices: Insights from the Evolving Pharma Landscape
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

Tufts Center for the Study of Drug Development (TCSDD) Working Group on Vendor Qualification will present updated Research Findings and Interactive Discussion on Addressing Industry-wide Challenges Associated with Qualification.

Learning Objectives

Understand the prevailing approaches to vendor qualification in small, mid and large pharma organizations including the level of effort required and time taken; Describe the impact on drug development timelines; Understand the point of view of clinical service providers from a time and cost standpoint; Identify how pharma companies and CROs are addressing qualification challenges.

Chair

Kenneth Getz, MBA

Speakers
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum
 
Wednesday, June 18
 

8:30am EDT

Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

Poor study management, misconduct, and data falsification threaten regulatory decisions on product safety and efficacy. This session will cover regulatory guidelines and case studies of clinical trial electronic systems, risk assessment strategies.

Learning Objectives

Describe regulatory expectations for electronic systems in clinical trials, including electronic health records (EHRs); Examine criteria for evaluating whether these systems are suitable for trials. Discuss methods for identifying and mitigating fraud and misconduct risks in these systems; Understand case studies of fraud and mismanagement to emphasize the need for thorough risk assessments.

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

10:30am EDT

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Basic

This panel will discuss whether flexible operational approaches like decentralization, embedding trials in clinical practice, and allowing setting adjustments will affect data quality. Real and perceived impediments to data quality will be explored.

Learning Objectives

Identify flexible trial approaches and their benefits and limitations; Assess when flexible trial approaches may impede data quality; Discuss solutions for maintaining data quality.

Chair

Lindsay Kehoe, MS

Speakers
avatar for Lindsay Kehoe

Lindsay Kehoe

Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
Lindsay Kehoe, M.S., C.G.C., is a senior project manager at the Clinical Trials Transformation Initiative (CTTI), where she manages the development and implementation of CTTI projects. She has convened teams around disease progression modeling, embedding trials into clinical practice... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum

1:45pm EDT

Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Overview of risk assessment methodologies used by regulatory authorities to decide on pharmacovigilance inspection planning and frequency including collaborative efforts to learn, develop and collaborate on current processes.

Learning Objectives

Define the methods and risk assessment considerations used by regulatory authorities to decide which entities are subject to pharmacovigilance inspections, including frequency, timelines and inspection type; Recognize the different approaches used among regulators to define risk and apply appropriate assessments and efforts to harmonize processes in future.

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

4:00pm EDT

Quality Briefs from Inception to Operationalization: How to Engage Internal Stakeholders
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

There is an opportunity to inspire and engage internal stakeholders on the value proposition of the Quality Brief. Sponsors will weigh in on the challenges and opportunities related to the value of the Quality Brief for their internal stakeholders.

Learning Objectives

Understand the internal value proposition for the Quality Brief and its application throughout the QMS and beyond; Apply different tactics to persuade and engage internal stakeholders on the value and application of the Quality Brief.

Chair

Kiernan Trevett, MSc

Speakers
avatar for Kiernan Trevett

Kiernan Trevett

Quality Policy Lead, Genentech, A Member of the Roche Group
Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP... Read More →
avatar for Mandy Budwal-Jagait

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 →
avatar for Jennifer Emerson

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 →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session
 
Thursday, June 19
 

9:00am EDT

Embedding and Leveraging AI for Quality and Compliance in Pharma
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD
Component Type: Session
Level: Intermediate

This session explores the transformative potential of AI in pharma quality and compliance, sharing use cases, strategies, and regulatory insights. Attendees will learn how AI can transform quality and compliance in pharmaceutical companies.

Learning Objectives

Share AI use cases in pharmaceutical quality management and compliance processes; Understand the role, benefits, and risks of using AI in quality management; Develop strategies for integrating AI technologies into existing pharmaceutical quality and compliance frameworks.

Chair

Hangyu (cedric) Liu, MS

Speaker

Ask the DS Directors: Challenges with running a cutting-edge pharmaceutical data science group in the age of GenAI 
Deepak Bandyopadhyay, PhD

Explainable Natural Language Processing: Why you see What you see
Meera Nagaria, MS


Speakers
avatar for Hangyu Liu

Hangyu Liu

Senior Manager, Data Scientist, Biogen, United States
Hangyu (Cedric) Liu is currently a Senior Manager, Data Scientist at Biogen's R&D Quality & Compliance team. He obtained a Master's degree in Data Science from Brown University, which ignited his passion for this field. Prior to joining Biogen, he worked as a Data Scientist in both... Read More →
avatar for Meera Nagaria

Meera Nagaria

Senior Data Scientist, Johnson & Johnson
avatar for Deepak Bandyopadhyay

Deepak Bandyopadhyay

Interim Head, Quality Analytics Data Sciences, Janssen, United States
Deepak Bandyopadhyay is a Computer Scientist by training who has spent his career developing methods and solving problems in the Life Sciences. He has worked as a Data Scientist and data science leader in many parts of the Pharma pipeline, including drug discovery, drug development... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session
 
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