Overview

This intensive, highly interactive two-day training course is designed to bridge the gap between regulatory theory and real-world clinical trial execution under the ICH E6(R3) guideline. One year into its implementation, this course provides a timely look at how the interplay between core principles and the annexes alters day-to-day operations.

Led by European Commission and EFPIA ICH E6(R3) Expert Working Group representatives, the programme abandons rigid, check-the-box training in favour of risk-proportional, practical application. Through a series of workshops, interactive panel discussions, and a progressive case study utilising a synthetic protocol, participants will learn how to operationalise Critical to Quality (CTQ) factors during protocol development and how to monitor then throughout the course of the trial, as well as manage modern data governance complexities, including computerised systems and automated data flows, and adapt to contemporary trial designs, directly addressing Annex 2 elements such as Decentralised Clinical Trials (DCTs), pragmatic trial elements, and the utilisation of Real-World Data (RWD).

Ample time is foreseen for Q&A. The faculty invites participants to submit related questions by 10 October 2026 latest. Submit your questions to training.emea@diaglobal.org

Who should attend?

This course is specifically tailored for mid-to-senior level clinical research professionals who are actively involved in the planning, conduct, and oversight of clinical trials and need to operationalise ICH E6(R3) in their day-to-day operations.
It is highly relevant for international professionals across sponsors (pharma/biotech), CROs, and investigative sites, including:
- Clinical Operations Directors, Managers, and Leads
- Clinical Trial Protocol Developers and Medical Writers
- Quality Assurance (QA) Auditors and Quality Management Professionals
- Clinical Monitoring Managers and Centralised Monitoring Specialists
- Data Governance Officers and Clinical Data Managers
- Regulatory Affairs Specialists
- Principal Investigators, Sub-Investigators, and Clinical Research Directors looking to understand updated oversight expectations.

Learning objectives

By the end of this two-day training, participants will be able to:
- Deconstruct the ICH E6(R3) Framework: Understand the structural interplay between the core principles and the annexes to apply them seamlessly to ongoing and future clinical programs.
- Implement Critical to Quality (CTQ) Factors: Identify, assess, and prioritize CTQs and their associated risks during the protocol development phase using a practical risk-proportional approach.
- Optimise Oversight & Responsibilities: Define and execute modern investigator and sponsor oversight responsibilities, with specific practical strategies for re-consenting and the management/oversight of service providers.
- Modernise Monitoring and Auditing: Design risk-based monitoring strategies, implement centralised monitoring approaches, and manage non-compliance effectively.
- Navigate Data Governance & Systems: Map complex clinical data flows, evaluate the "fitness for purpose" of computerised systems, and manage expectations around database locks and statistical programming.
- Apply Annex 2 Principles to Modern Trials: Confidently evaluate the quality, governance, and GCP compliance of trial designs incorporating decentralised (DCTs), pragmatic elements, and real-world data (RWD).
- Redefine Essential Records: Transition away from the rigid "before, during, and after" tables of R2 to build a risk-proportional essential records strategy.

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ICH GCP: 1 year on – practical tips on implementation

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ICH GCP: 1 year on – practical tips on implementation

Overview

Who should attend?

Learning objectives

Digital Learning Catalog

ICH GCP: 1 year on – practical tips on implementation

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