You’re coming towards the end of your clinical study, but you’re about to face one of the biggest challenges yet… your TMF inspection. This remains one of the most daunting tasks, and there’s no one way to prepare your TMF system, meaning it’s absolutely vital that your system remains regulatory compliant, accurate and complete to ensure you’re taking the best approach possible to ensure audit success, the FIRST time!

Discover how you can optimise your TMF processes by attending the 5th Annual Trial Master Files and Inspection Readiness Summit and be guided through our most interactive programme yet! With focuses on sponsor and CRO oversight, TMF interoperability, eTMF transition and securing senior management support – this event is the only platform where you can benchmark with the principle experts within the TMF industry through a 100% interactive program


2019's Expert Speakers and Facilitators

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Top Reasons to Attend:

TMF Exchange Mechanisam

Hear first hand how the TMF Exchange Mechanism will help revolutionise the way we solve interoperability issues in eTMF platforms

Strengthen your eTMF strategy with all new Case Studies and Interactive Discussions

Sponsors and CROs share real experiences with their TMFs so you can ensure your TMF process improvement.

Learn how to secure senior management buy-in for TMF activities

Attend interactive sessions and case studies to understand how you can get your senior management on board!

Get those answers you've been desperately seeking!

This year's 100% Interactive Programme delivers a discussion based agenda that is the perfect industry platform for you to gain key takeaways and solutions to your biggest challenges.

As part of the Inspection Readiness Week, we're also hosting the GCP and Inspection Readiness Forum

Join the GCP and Inspection Readiness Forum to explore real-life case studies from Bluebird Bio as they compare their recent FDA and EU inspections and present lessons learned, deep-dive into how a PPD are preparing for their upcoming MHRA inspection, and even hear from a previous member of the EMA Inspection Sector has taken her knowledge of inspections and applied a new role in Quality Assurance at Johnson and Johnson. As Europe’s most interactive forum of its kind, the GCP and Inspection Readiness Forum will give you the confidence you are inspection ready.

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