DIA 2024 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-523-L04-P; CME 1.00; RN 1.00

In this session, we will invite speakers from EMA, FDA, and PMDA, and share the latest regulations, perspective to revised ICH guidelines, and challenges to implement the guideline in own region.

Learning Objectives

Recognize direction of revising ICH-GCP guideline; Discuss how to utilize it in real inspection.

Chair

Junko Sato, PhD

Speaker

FDA Update
Kassa Ayalew, MD, MPH

EMA Update
Peter Twomey

PMDA Update
Yoshiaki Nodera, MPharm

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-538-L04-P; CME 1.00; RN 1.00

This session will discuss regulatory and industry perspectives on building quality into clinical trials by providing updates to agency policy of risk-based monitoring (RBM), quality risk management (QRM), and quality-by-design (QbD) (e.g., ICH E6R3, ICH E8R1, draft and final guidances), including case examples.

Learning Objectives

Discuss the importance of building quality into clinical trials; Identify a study’s critical quality (CTQ) factors and the importance of involving all stakeholders in their identification; Describe FDA’s expectations for implementing quality-risk management and developing and executing risk-based monitoring plans to focus on CTQ factors with inspection case examples of sponsors, CROs, service providers and clinical investigators.

Chair

Kenneth Getz, MBA

Speaker

MHRA Update
Jason Wakelin-Smith

FDA Update
Elena Boley, MD, MBA, FACP

Industry Update
Michael Torok, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-551-L04-P; CME 1.00; RN 1.00

This session discusses regulator and industry experience with the use of alternative tools to evaluate GCP compliance during the COVID-19 public health emergency and post-pandemic.

Learning Objectives

Discuss the alternative, innovative, risk-based approaches regulators used to evaluate GCP compliance during the COVID-19 public health emergency; Describe the application of these tools in the post-pandemic environment; Explain industry’s perspective on and experiences with regulators' use of alternative approaches to GCP evaluations.

Chair

Emily Gebbia, JD

Speaker

FDA Update
Ling Yang, MD, PhD, FAAFP

Beyond the Pandemic, Sustaining Approaches to GCP Compliance
Paula Walker, MA

Health Canada Update
Jennifer Evans

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-563-L04-P; CME 1.00; RN 1.00

In this session, the speakers will emphasize the importance of involving data scientists in the identification of a critical to quality factor’s and will discuss implementation of risk proportionate processes and procedures related to these data governance procedures to address the risks to the critical to quality factors. The speakers will their perspectives related to good data governance practices and provide updates to policy related to data governance (e.g., ICH E6R3, ICH E8R1, 21 CFR part 11) and inspection case examples of clinical trials to illustrate the impact of poor data governance procedures.

Learning Objectives

Discuss the importance of good data governance practices; Identify a study’s critical to quality factors related to data governance processes and procedures; Discuss the importance of involving the data scientist in the identification of a study’s critical to quality factors; Describe inspection case examples to illustrate regulatory expectations for data governance and the use of technology in clinical trials.

Chair

Kassa Ayalew, MD, MPH

Speaker

Update from the Danish Medicines Agency
Lisbeth Bregnhoj, PhD, MPharm

Update from Industry
Prasanna Rao

Update from the FDA
Cheryl Grandinetti, PharmD

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-578-L04-P; CME 1.00; RN 1.00

Hear the thoughts of regulators regarding how they see the future direction of travel for GCP Inspections. Learn about changes to compliance strategies and collaboration initiatives which are underway or in the pipeline.

Learning Objectives

Describe challenges currently faced by regulators regarding clinical trial inspections; Discuss strategies being developed by Health Authorities including future initiatives, direction of travel, and collaborative relationships.

Chair

Jason Wakelin-Smith

Speaker

FDA Update
Emily Gebbia, JD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-590-L04-P; CME 1.00; RN 1.00

The speakers will discuss regulatory and industry perspectives on sponsor and investigator responsibilities when incorporating decentralized clinical trials features in a trial to ensure trial participant safety, data reliability and quality and inspection readiness.

Learning Objectives

Describe various design features of decentralized clinical trials (DCT), including use of digital health technologies for remote data capture; Discuss what sponsors should do upfront in the planning and during the conduct of the trial and where the risks to data integrity lie in trials incorporating DCT features; Discuss the core elements of an FDA inspection; Identify steps to ensure inspection readiness for clinical investigators and sponsors.

Chair

Cara Alfaro, PharmD

Speaker

FDA Update
Cara Alfaro, PharmD

Industry Update
Jonathan Andrus, MS

MHRA Update
Jason Wakelin-Smith

Component Type: Session

Join the Good Clinical Practices & QA Community for a follow up round table discussion tied to session: Good Data Governance Practices and the Importance of Incorporating Input from the Data Scientist in Quality by Design (Tuesday, June 18 | 8:00AM - 9:00AM PDT). Space is limited.

Chair

Terry Katz, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-603-L04-P; CME 1.00; RN 1.00

This session will bring regulators and industry quality experts together to explore how quality management systems can be developed to meet the challenges real-world evidence presents to QA activities and regulatory inspection expectations.

Learning Objectives

Evaluate quality challenges associated with the use of real-world evidence as part of regulatory studies; Discuss how to apply proportionate risk-based quality assurance activities which meet regulatory expectations.

Chair

Andrew Gray, PhD

Speaker

FDA Update
L'Oreal Walker

FDA Update
Lee H. Pai-Scherf, MD

Industry Perspective
Abi Seifert, MBA

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-616-L04-P; CME 1.00; RN 1.00

Understanding the safety of medicines and the risks imposed by their use is of interest to regulators around the world. This poses challenges for industry who are faced with meeting the regulatory requirements and expectations of multiple Healthcare Agencies from across the globe. This challenge is becoming greater still as more countries start to enter the world of PV.

This session will focus on how regulators are working together to share information and intelligence and how experienced regulatory agencies are working with nations currently establishing pharmacovigilance regulations to implement these and develop the skills and knowledge required to ensure compliance and establish accepted best practice.

Learning Objectives

Describe the challenges faced by industry from a global perspective and gain insight into how regulatory agencies are working together to combat some of these issues; Discuss information and educate countries where PV is an emerging concept; Discuss areas where processes can be improved to make global PV more aligned and less challenging for industry and regulators alike.

Chair

Sophie Radicke, MSc

Speaker

FDA Update
Carolyn A Volpe, PharmD, MS

Update from Ghana
Adela Ashie

MHRA Update
Sarah Vaughan

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-642-L04-P; CME 1.00; RN 1.00

This session will consist of perspectives and case studies of how data-driven solutions are being leveraged to support the development of quality assurance strategies for pharmacovigilance activities and to generate quality evidence in relation to Good Pharmacovigilance Practice (GVP) compliance.

Learning Objectives

Investigate the use of data-driven solutions to develop quality assurance strategies for Good Pharmacovigilance Practice (GVP) activities and to generate quality evidence in relation to GVP compliance.

Chair

Kiernan Trevett, MSc

Speaker

Industry Update
Michelle Ruiz

Industry Update
John Okudjeto, MSc

MHRA Update
Sophie Radicke, MSc

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-654-L04-P; CME 1.00; RN 1.00

This session explores four use cases of AI's potential to revolutionize quality management (QM) decision making and enhance organizational processes. Discover how AI is being implemented within QM and AI's role in identifying trends and driving improvement initiatives.

Learning Objectives

Describe the role of AI for quality management (QM) decision making, with a focus on advanced data analysis and pattern recognition, quality risk management, inspection readiness and drive continuous improvement initiatives; Identify practical use cases of AI in enterprise QMS, metadata extraction, risk assessment, and knowledge management systems, showcasing the benefits of AI integration.

Chair

Oliver Fink, MS

Speaker

AI Embedded Capabilities in an Enterprise Quality Management System
Michael Pelosi, MA, MBA, MSc

Augmenting Quality Assurance Activities with AI
Oeystein Kjoersvik, MS, MSc

AI Use Cases in Regulatory Monitoring
Haleh Valian, PhD