Trial Master File and Inspection Readiness Summit

Brussels, Belgium


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.

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.

"Good mix of experience from different perspectives (sponsors, CROs, MHRA) made the event extremely valuable. Overall level of expertise and experience of all speakers was very high!"

"I am so glad I did not miss this one! Highly relevant content, very helpful. Overall, a high standard of people ready to interact and discuss."
GW Pharmaceuticals

"I learned more about TMFs this week than I ever have. It was very informative on a practical level."

2019 Expert Speakers and Facilitators Include:

  • Jamie Toth, Head of TMF Operations, Daiichi Sankyo
  • Gerard Barron, Director of Clinical Operations, MedImmune
  • Eldin Rammell, Director, Client Solutions, Phlexglobal
  • Marie-Christine Poisson-Carvajal, Head of TMF Operations, Pfizer
  • Gertrud Rasmussen, Director of Clinical Operations, Zealand Pharma
  • Christopher Betts, Clinical Operations Manager, UK Country Head, DOCS
  • Rebecca Halbur, Senior TMF Manager, Biogen
  • Maria Nymann Jensen, Competency Development Professional, Novo Nordisk
  • Roman Widi, Unit Lead within the Regional Documentation Management Group, Boehringer Ingelheim Pharma RCV GmbH & Co KG
  • Anne-Mette Varney, Trial Master File System and Process Manager, Novo Nordisk
  • Sarah Dean, Director, TMF Operations, Syneos Health
  • Catherine Boulard, Systems & Standards Manager, IPSEN Innovation
  • Francis Crawley, Executive Director, Good Clinical Practice Alliance - Europe
  • Liz Farrell, Senior TMF Manager, Biogen
  • Dounia Sbai, Director, Quality Assurance, IPSEN Innovation
  • Martina Duevel, Systems Excellence Project Leader, Bayer
  • Ann McCabe, Director, Process Excellence & Risk Management, Clinical Development Operations, Daiichi Sankyo
  • Monica Alaimo, Director, TMF Operations, Syneos Health
  • Hobson Lopes, Manager, Clinical Archive Management, Clinical Document Management Group | Global Clinical Operations, Regeneron
  • Annebeth Jensen, Principal Competency Development Specialist, Novo Nordisk

2019 Advisory Board

  • Jamie Toth, Head of TMF Operations, Daiichi Sankyo
  • Paul Fenton, TMF Reference Model Steering Committee Member and eTMF-EMS Sub-group Co-chair, TMF Reference Model
  • Dr Robin Farmer, Associate Director of Clinical Document Control and Training, Dynavax
  • Scott McCulloch, Director, GCP Quality, and TMF RM SC Member, InClin Inc
  • Stephen Nabarro, Head of Clinical Operations and Data Management, Cancer Research UK
  • Gerard Barron, Director of Clinical Operations, MedImmune
Training Day - 16th September 2019

Conference Day One - 17th September 2019

Conference Day Two - 18th September 2019

Workshop Day - 19th September 2019


Pullman Brussels Centre Midi Hotel
Place Victor Horta 1
1060 Bruxelles, Brussels
Phone: +32 2 528 98 00

Travel and accommodation are not included in the conference fee; however we have put together a HotelMap that displays discounted accommodation for hotels in the area near to Trial Master File and Inspection Readiness 2019. The map displays live availability and allows you to book directly with each hotel:

Please note: We will never recommend, approve or appoint any third party rooming service to act on our behalf. Please be extremely wary if you are approached by any such companies. We will always endeavour to negotiate the best available rates for you so please use the Hotel's website link provided.