Workshop Details

Dates

March 20, 2025

Time

1:00 pm – 2:00 pm

Cost

CAD $99 + HST

Location

Online

Deadline

March 13, 2025

Workshop Overview

The newly released ICH E6(R3) Good Clinical Practice (GCP) guidelines mark a transformative shift in clinical trial design, conduct, and oversight. This workshop will provide an in-depth analysis of these changes and their real-world applications, equipping clinical research professionals with the knowledge to implement them effectively. The latest revisions emphasize modernized trial methodologies, enhanced technology adoption, greater flexibility in trial designs, and a stronger focus on patient-centric approaches. Through case studies and expert discussions, attendees will gain insights into how these changes impact regulatory compliance, trial efficiency, and data integrity. Join us to explore how the latest GCP updates are shaping the future of clinical research and discover practical strategies for integrating these innovations into your trials.

Who Should Attend​

This workshop is designed for:

  • Clinical research professionals, including CRAs, CRCs, and Clinical Project Managers
  • Sponsors, investigators, and regulatory professionals
  • Medical writers and data management specialists
  • Anyone involved in clinical trial design, monitoring, or compliance seeking to stay ahead of regulatory changes

Workshop Outline

This workshop covers the following topics:

  • Introduction to ICH E6(R3) and the evolution of GCP
  • Modernized Trial Design and Conduct
  • Enhanced Use of Technology
  • Improved Trial Design Flexibility
  • Patient-Centric Approach
  • Regulatory and Compliance Considerations

Learning Outcomes

Understand Key Updates in ICH E6(R3):

Gain a comprehensive understanding of the latest updates in ICH E6(R3) and how these changes impact clinical research operations and compliance.

Apply Modernized Trial Methodologies:

Learn how to integrate modernized trial methodologies to improve trial efficiency, ensure compliance, and streamline operational processes.

Leverage Technology for Data Integrity:

Understand the role of technology in enhancing data integrity and improving trial monitoring, ensuring high-quality, reliable results.

Implement Patient-Centric Strategies:

Explore patient-centric strategies designed to improve recruitment, retention, and engagement, ensuring a more successful clinical trial outcome.

Develop a Roadmap for Implementing GCP Guidelines:

Gain practical insights into how to implement the new GCP guidelines into day-to-day clinical trial operations, ensuring seamless adaptation and compliance.

All participants will receive a certificate of attendance upon completion of the workshop.

Note: Registration closes one week prior to the start of workshop.

Future-Proofing Clinical Trials: Essential GCP Updates You Need to Know

March 20, 2025

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Dr. Tigran Uzunyan

Clinical Research

Tigran Uzunyan is a medical doctor and research scientist with over 18 years of diversified experience in academia, pharmaceutical industry and clinical research. Tigran acquired a degree of medical doctor and then specialized in clinical pharmacology in Yerevan, Armenia. In 2008 he defended his PhD thesis in pharmacology.

Tigran Uzunyan has an extensive experience in drug development and regulation under various jurisdictions, designing and conducting early phase (bioequivalence, bioavailability, first in human, etc.) and late phase (II to IV) clinical and observational studies. He also managed medical cannabis development research projects in Canada.