Welcome to our webinar Stay Ready, Stay Compliant: Key Strategies to Prepare for and Succeed in a Clinical Trial Inspection under ICH E6(R3)
In an ever-evolving regulatory environment, where requirements for quality, traceability, governance and data integrity continue to strengthen, preparation for a regulatory inspection can no longer be considered a one-off, downstream exercise. It must now be embedded from the very outset — at the design stage of the study, processes, systems and organisational structure.
This one-hour webinar will provide a methodological, operational and strategic perspective on inspection readiness, in light of the principles set out in ICH E6(R3). It will highlight current health authority expectations, as well as practical levers enabling sponsors, CROs and investigative sites to build a robust, risk-proportionate and inspection-defensible framework.
Agenda:
- Recent developments in the GCP framework and key contributions of ICH E6(R3)
- Why inspection readiness must be integrated at the study design stage
- Key pillars of an inspection-ready organisation: governance, documentation, systems, data and oversight
- Major inspector focus areas and the most frequently observed vulnerabilities
- A practical approach to preparing for, conducting and securing a regulatory inspection
- Q&A session
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