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ICH E6 R3: Are you confident in your implementation?

You’ve implemented ICH E6 R3 – but did you cover everything? Did your approach strike the right balance between compliance and proportionality? Are you confident your processes will stand up to inspection?

This webinar provides a pragmatic view on post-implementation validation, highlighting common gaps, risks of over-engineering and ways to strengthen what’s in place. Through a case study from our Clinical Pharmacology Unit’s Medical Director, we’ll illustrate how to validate your processes after transition and take a proportionate, risk-based approach to compliance.

Agenda

  • ICH E6 R3: A quick refresher on what’s changed and why it matters now
  • Case study: Transition experience and lessons from SGS’ Medical Director, CPU
  • Approaching compliance validation: gap analysis, documentation, and training where needed
  • Q&A: Bring your questions — our experts are ready to help

Who should attend?

The webinar is aimed at pharma and biotech sponsors, CROs, sites and service providers involved in clinical trial processes impacted by ICH E6 R3 — especially those who have implemented the guideline but seek validation or improvement support.

Register now

This event takes place on September 30, 2025, at 03:00 PM (CEST).

Presenters:

Bert Peeters

Bert Peeters

Quality Compliance Manager, Sr. Quality Assurance Auditor, SGS
​Jelle Klein

Jelle Klein

Medical Director CPU, SGS

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