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.
This workshop is designed for:
This workshop covers the following topics:
Gain a comprehensive understanding of the latest updates in ICH E6(R3) and how these changes impact clinical research operations and compliance.
Utilize Real World Data (RWD) and Real World Evidence (RWE):Understand how to incorporate RWD and generate RWE to complement traditional clinical trial data, support regulatory decision-making, and advance evidence-based approaches in drug development and post-marketing surveillance.
Implement Patient-Centric and Decentralized Strategies:Explore innovative patient-centric models, including decentralized clinical trials (DCTs), digital health technologies (DHTs), and telemedicine tools, to improve trial accessibility, patient engagement, recruitment, and retention while maintaining protocol integrity and data quality.
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. Workshop registration is intended for individual use only. Each registration grants access to one participant. If you plan to attend as a group or company team, please ensure that each participant is registered separately. Group rates and corporate packages are available—contact us for details.
Refunds are only available if cancellation is requested at least 48 hours before the workshop. No refunds will be issued for late cancellations.
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.
