Preparing for GCP (Good Clinical Practice) Inspections: Key Expectations under ICH GCP (Good Clinical Practice) E6(R3), EU (European Union) CTR and Current Regulatory Thinking In-house Training

Course overview

Regulatory expectations in clinical research continue to evolve, particularly with the introduction of ICH GCP E6(R3) and the implementation of the EU Clinical Trials Regulation (CTR). Regulators are increasingly focusing on risk‑based governance, data integrity, oversight of vendors and CROs, and the use of technology and digital processes in trials.

This practical one‑day course focuses on what inspectors from EU authorities, the MHRA and the FDA are currently looking for during inspections. Rather than reviewing guidance documents in isolation, the programme concentrates on how regulatory expectations are interpreted and applied in real inspection situations.

Participants will gain a clear understanding of the most common inspection findings, how organisations are challenged by regulators, and the practical steps that clinical teams can take to demonstrate compliance and inspection readiness.

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Benefits of attending

By attending this course participants will:

• Gain a clear overview of current inspection focus areas
• Understand the most important changes introduced by ICH GCP E6(R3)
• Clarify expectations around risk‑based approaches, governance and oversight
• Refresh their understanding of essential documentation and TMF requirements
• Understand how data integrity is assessed during inspections
• Explore how inspectors view technology, digitalisation and AI in trials

Who should attend

This course is suitable for professionals who need to stay current with GCP requirements and inspection expectations, including:

• Clinical Research and Clinical Operations professionals
• Regulatory Affairs professionals supporting clinical trials
• Quality Assurance and Audit professionals
• Pharmacovigilance professionals involved in trial oversight
• CRO and vendor staff working with sponsors
• Academic trialists involved in regulated studies
• It is particularly relevant for those who need to demonstrate up‑to‑date GCP training during inspections or audits