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Agenda

Details on speakers will be available soon


8:00 AM - 5:00 PM

  1. GCP - Navigating ICH E6 (R3) revision and regulatory updates: a cultural shift from trial design to execution

    Tuesday, June 02 8:00 AM - 5:00 PM
    Summary
8:30 AM - 8:45 AM

  1. Welcome

    GCP
    Tuesday, June 02 8:30 AM - 8:45 AM
    Summary


8:45 AM - 9:00 AM

  1. Opening remarks & keynote address

    GCP
    Tuesday, June 02 8:45 AM - 9:00 AM
    Summary


9:00 AM - 10:00 AM

  1. Session 1: Shifting the mindset: embedding quality and proportionality in clinical trials

    GCP
    Tuesday, June 02 9:00 AM - 10:00 AM
    Summary

    Objectives

    • Explain the foundational principles of ICH E6 (R3) and how they build upon the concepts introduced in ICH E8 (R1)
    • Describe the cultural and mindset shift needed across organizations to embed quality by design (QbD) and risk-proportionate approaches in the design and conduct of clinical trials
    • Demonstrate how QbD and risk-proportionate practices can be applied to ensure clinical trials address important research questions, operate efficiently, and produce reliable data that supports sound decision-making
    • Analyze case examples of simple and complex trial designs to distinguish effective from ineffective implementation of QbD and risk-based decision-making
10:00 AM - 10:20 AM

  1. Break

    Tuesday, June 02 10:00 AM - 10:20 AM
    Summary
10:20 AM - 11:30 AM

  1. Session 2: Beyond the checklist: culture, critical thinking, and case examples of risk-based quality management (RBQM) in action

    GCP
    Tuesday, June 02 10:20 AM - 11:30 AM
    Summary

    Objectives

    • Describe the purpose and components of RBQM and its alignment with QbD
    • Explain how risk assessments drive proactive trial management including expectations for documented risk assessments and their role in trial oversight
    • Identify regulatory expectations for RBQM implementation and fostering a culture of transparency
    • Apply RBQM principles to real-world scenarios, using case examples
11:30 AM - 12:00 PM

  1. Panel discussion (sessions 1 and 2)

    GCP
    Tuesday, June 02 11:30 AM - 12:00 PM
    Summary
12:00 PM - 1:15 PM

  1. Lunch break

    Tuesday, June 02 12:00 PM - 1:15 PM
    Summary
1:15 PM - 2:15 PM

  1. Session 3: Balancing oversight and burden: fostering a culture of risk proportionate expectations across the clinical trial

    GCP
    Tuesday, June 02 1:15 PM - 2:15 PM
    Summary

    Objectives

    • Describe expectations for implementing ICH E6 (R3), including responsibilities of sponsors and investigators
    • Explain how risk-proportionate approaches can be applied to oversight, documentation, and operational expectations to support efficiency without compromising quality
    • Discuss how to operationalize ICH E6 (R3) and reduce unnecessary complexity and burden at investigator sites, balancing quality expectations with site-specific capabilities and workflows
2:15 PM - 3:15 PM

  1. Session 4: Applying risk proportionate strategies to innovative clinical trial designs

    GCP
    Tuesday, June 02 2:15 PM - 3:15 PM
    Summary

    Objectives

    • Discuss regulatory expectations for clinical trials incorporating decentralized and pragmatic trial elements, emphasizing alignment with ICH E6 (R3) Annex 2
    • Explore key considerations for using real-world data (RWD) into clinical trials, focusing on ensuring data quality, meeting regulatory requirements, and supporting effective risk-based quality management
    • Discuss risk-based oversight strategies throughout the lifecycle of the clinical trial
    • Evaluate case examples to assess data quality, integrity, and effective oversight practices in trials incorporating decentralized elements, pragmatic elements, and real-world data sources
3:15 PM - 3:35 PM

  1. Break

    Tuesday, June 02 3:15 PM - 3:35 PM
    Summary
3:35 PM - 4:30 PM

  1. Session 5: Clinical trial quality at the core: ensuring reliable safety decisions in modern clinical trials

    GCP
    Tuesday, June 02 3:35 PM - 4:30 PM
    Summary

    Objectives

    • Discuss the prioritization of trial quality and safety by fostering a shift in organizational mindset
    • Explain the critical role of data reliability in safety-related decisions throughout the clinical trial lifecycle
    • Identify critical to quality factors related to participant safety and describe quality control expectations
    • Analyze case studies illustrating the impact of data errors on participant safety
4:30 PM - 5:00 PM

  1. Panel discussion (sessions 3, 4, 5)

    GCP
    Tuesday, June 02 4:30 PM - 5:00 PM
    Summary
5:00 PM - 5:15 PM

  1. Wrap-up and closing remarks

    GCP
    Tuesday, June 02 5:00 PM - 5:15 PM
    Summary
8:00 AM - 12:00 PM

  1. GCP - Navigating ICH E6 (R3) revision and regulatory updates: a cultural shift from trial design to execution

    Wednesday, June 03 8:00 AM - 12:00 PM
    Summary
8:30 AM - 9:00 AM

  1. Welcome, opening remarks & keynote address

    GCP
    Wednesday, June 03 8:30 AM - 9:00 AM
    Summary
9:00 AM - 10:05 AM

  1. Session 1: Preparing for change: building a culture of quality through regulatory insights and international partnership

    GCP
    Wednesday, June 03 9:00 AM - 10:05 AM
    Summary

    Objectives

    • Summarize recent updates to GCP-related regulations and guidance from FDA, MHRA, and Health Canada, highlighting their impact on clinical trial quality and inspection readiness
    • Discuss the global harmonization of GCP regulations and collaborative efforts to support consistent implementation of ICH E6 (R3) and facilitate international trial compliance
    • Highlight organizational strategies to prepare for upcoming regulatory changes, including insights from Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the role of intelligence sharing to enhance quality and oversight
    • Highlight recent achievements and joint initiatives since the last symposium, reinforcing the value of regulatory collaboration in advancing clinical trial quality
10:05 AM - 10:25 AM

  1. Break

    Wednesday, June 03 10:05 AM - 10:25 AM
    Summary
10:25 AM - 11:30 AM

  1. Session 2: Beyond the findings: regulators driving a culture shift in inspection

    GCP
    Wednesday, June 03 10:25 AM - 11:30 AM
    Summary

    Objectives

    • Discuss remote regulatory assessments, including inspection activities and expectations to support effective compliance oversight
    • Explore the impact of ICH E6 (R3) and the adoption of risk-proportionality approaches in regulatory inspections
    • Discuss the role of sponsor and regulator collaboration in fostering transparency and applying risk-proportionate strategies
    • Overview and summary of GCP topics over the 2-day symposium and future perspectives
11:30 AM - 12:00 PM

  1. Panel discussion (sessions 1 and 2)

    GCP
    Wednesday, June 03 11:30 AM - 12:00 PM
    Summary
12:00 PM - 1:15 PM

  1. Lunch break

    Wednesday, June 03 12:00 PM - 1:15 PM
    Summary
12:30 PM - 5:00 PM

  1. BE - Enhancing oversight in bioequivalence trials: sharing insights from regulators on methods of review, case studies, and ensuring data integrity

    Wednesday, June 03 12:30 PM - 5:00 PM
    Summary
1:15 PM - 1:30 PM

  1. Bioequivalence compliance keynote

    BE
    Wednesday, June 03 1:15 PM - 1:30 PM
    Summary
1:30 PM - 2:30 PM

  1. Session 3: Regulatory perspectives and insights on bioequivalence studies

    BE
    Wednesday, June 03 1:30 PM - 2:30 PM
    Summary

    Objectives

    • Highlight how sponsors, applicants and researchers can learn from agency case studies and experience of bioequivalence trials
    • Explore case studies that will highlight opportunities to critical thinking to applications prior to submission
    • Explore the challenges regulators have following high-profile lapses in data integrity
2:30 PM - 3:30 PM

  1. Session 4: Inspector perspectives and insights on bioequivalence studies

    BE
    Wednesday, June 03 2:30 PM - 3:30 PM
    Summary

    Objectives

    • Highlight how sponsors, applicants and researchers can learn from inspections of bioequivalence trials
    • Analyse case studies that will highlight:
      • areas of serious non-compliance
      • methods of review to provide sponsors / applicants potential tools when looking at their own studies
      • what to consider if faced with data integrity concerns
3:30 PM - 3:50 PM

  1. Break

    Wednesday, June 03 3:30 PM - 3:50 PM
    Summary
3:50 PM - 4:45 PM

  1. Panel discussion (sessions 3 and 4)

    BE
    Wednesday, June 03 3:50 PM - 4:45 PM
    Summary
4:45 PM - 5:00 PM

  1. Wrap-up and closing remarks

    BE
    Wednesday, June 03 4:45 PM - 5:00 PM
    Summary
8:00 AM - 5:00 PM

  1. GVP - Collaborative views on pharmacovigilance inspections; current and future thinking

    Thursday, June 04 8:00 AM - 5:00 PM
    Summary
8:30 AM - 9:00 AM

  1. Welcome, opening remarks & keynote address

    Thursday, June 04 8:30 AM - 9:00 AM
    Summary
9:00 AM - 9:50 AM

  1. Session 1: Beyond borders: international collaboration in GVP inspections

    GVP
    Thursday, June 04 9:00 AM - 9:50 AM
    Summary

    Objectives

    • Representatives from the three regulatory GVP inspection programs will discuss tripartite efforts to collaborate and reduce burden on industry by:
      • explaining how agencies collaborate in enhancing information sharing on GVP inspection, regulatory expectations and new technologies
      • updating the status of ongoing projects and highlight learnings and outcomes
      • exploring ongoing and future involvement in international regulatory projects beyond the tripartite framework
9:50 AM - 10:30 AM

  1. Session 2: Artificial intelligence (AI) in pharmacovigilance systems: a joint vision from inspectors

    GVP
    Thursday, June 04 9:50 AM - 10:30 AM
    Summary

    Objectives

    • A joint panel of regulators from GVP inspection programs will share their insights on the current landscape of AI/machine learning (ML) integration in pharmacovigilance systems. They will also discuss their vision for inspection readiness in the context of evolving AI technologies:
      • International collaboration for AI in PV (PICS WG and CIOMS WG)
      • Thoughts for inspection approaches for AI/ML PV systems
      • Inspection readiness for AI systems
      • Potential document requests
10:30 AM - 10:50 AM

  1. Break

    Thursday, June 04 10:30 AM - 10:50 AM
    Summary
10:50 AM - 12:10 PM

  1. Session 3: Regulatory updates and inspection strategies

    GVP
    Thursday, June 04 10:50 AM - 12:10 PM
    Summary

    Objectives

    • Receive the latest regulatory updates from each agency
    • Discuss collaboratively on inspection formats
    • Discuss how organizations can facilitate inspection readiness and a successful inspection
12:10 PM - 12:30 PM

  1. Panel discussion (sessions 1 and 2)

    GVP
    Thursday, June 04 12:10 PM - 12:30 PM
    Summary
12:30 PM - 1:45 PM

  1. Lunch break

    Thursday, June 04 12:30 PM - 1:45 PM
    Summary
1:45 PM - 2:45 PM

  1. Session 4: Inspection insights: key metrics and common pitfalls

    GVP
    Thursday, June 04 1:45 PM - 2:45 PM
    Summary

    Objectives

    • Review inspection metrics and trends
    • Highlight the most frequent inspection findings
    • Discuss case studies with recommended corrective and preventive actions
    • Identify recurring global deficiencies affecting local compliance
2:45 PM - 3:45 PM

  1. Session 5: A robust pharmacovigilance system that drives continuous improvement

    GVP
    Thursday, June 04 2:45 PM - 3:45 PM
    Summary

    Objectives

    • Discuss robust quality management principles that support the delivery of comprehensive safety data
    • Identify best practices in vendor management that ensures accountability and addresses hidden risks early
3:45 PM - 4:05 PM

  1. Break

    Thursday, June 04 3:45 PM - 4:05 PM
    Summary
4:05 PM - 4:35 PM

  1. Panel discussion (sessions 3, 4 and 5)

    GVP
    Thursday, June 04 4:05 PM - 4:35 PM
    Summary
4:35 PM - 4:50 PM

  1. Wrap-up and closing remarks

    GVP
    Thursday, June 04 4:35 PM - 4:50 PM
    Summary

Information

Dates: June 2–4, 2026

Times:

Day 1: Tuesday, June 2 | 8:30 AM – 5:15 PM ET
Day 2: Wednesday, June 3 | 8:30 AM – 5:00 PM ET
Day 3: Thursday, June 4 | 8:30 AM - 4:50 PM ET

Event Type: Hybrid event

Location :

Library and Archives Canada,
395 Wellington St, Ottawa, Ontario, Canada
and Virtual

Cost: Free registration

Contact us

For questions regarding the Symposium contact us at: 2026Symposium@hc-sc.gc.ca