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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

1:00pm EDT

22P: Accelerating Breakthroughs: Project Management Strategies in Drug Development
Tuesday June 10, 2025 1:00pm - 4:00pm EDT
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-503-L04-P; CME 2.75; IACET 2.75; PDU 2.75 PMI 2166LKA26P; RN 2.75

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. This Short Course will be offered virtually – Join from anywhere!This short course provides a focused, in-depth exploration of how established project management frameworks, tools, and best practices can be applied specifically to the drug development process. Participants will begin by examining a range of methodologies—such as Agile, Waterfall, and hybrid approaches—to understand which strategies work best for managing the multifaceted challenges of clinical trials. Through guided instruction, attendees will learn how to adapt these methodologies to meet stringent regulatory requirements, handle complex demands, and maintain stringent quality standards. In addition to foundational methodologies, this course delves into practical tools and templates that streamline project planning, risk management, and communication. These tools help teams navigate the intricate timelines associated with bringing a drug to market, enabling participants to anticipate and mitigate risks before they become obstacles. By learning to identify common bottlenecks and implement effective contingency plans, attendees can keep projects on schedule and budget, ensuring that new therapies reach patients faster. A central component of the course focuses on enhancing cross-functional collaboration. Participants will learn strategies to improve communication among scientific, clinical, regulatory, and operational teams, ensuring that everyone shares a common understanding of project goals and responsibilities. This improved alignment not only accelerates decision-making but also fosters a more cohesive and productive working environment. To reinforce these concepts, the course provides real-world examples and case studies to give participants hands-on experience in applying project management principles, evaluating risk, adjusting timelines, and coordinating team efforts in real-world scenarios. In addition, advanced tools and techniques are introduced, equipping learners with cutting-edge resources that support informed decision-making and efficiency throughout the drug development lifecycle. By the end of this program, participants will have gained a practical, customizable toolkit they can immediately apply in their daily work. Participants will emerge with greater confidence in managing complex drug development and clinical research projects, ultimately improving trial outcomes and accelerating the delivery of innovative therapies to the patients who need them. 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. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Professionals working in or interested in drug development who seek to improve their project management knowledge and skillset. Roles that would benefit from this course include project managers, clinical research associates, data managers, regulatory specialists, and clinical operations staff, amongst others, who aim to streamline processes and deliver projects on time and on budget to accelerate the development of new therapies.

Learning Objectives

  • Identify key project management methodologies and tools to improve efficiency in drug development
  • Discuss drug development timelines by learning strategies to manage risks, streamline timelines, and overcome bottlenecks
  • Apply Cross-Functional Collaboration to ensure smoother project execution and faster delivery of therapies


Speakers
JT

Jessica Thompson

Founder, CEO, Clinical Research Project Management Association, United States
Tuesday June 10, 2025 1:00pm - 4:00pm EDT
Virtual Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
 
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