16 - 19 September, 2019 | Pullman Brussels Centre Midi Hotel, Brussels, Belgium

Conference Day Two

9:00 am - 9:30 am Registration and Coffee

9:30 am - 9:40 am Chairmwoman's Recap of Day One

9:40 am - 10:20 am Living in the TMF health zone – Understanding the impact of digital transformation

  • Understand how processes and systems can be optimized to improve the health of your TMF
  • Learn how digital transformation is different from digitisation
  • Explore the potential for taking a TMF beyond the eTMF

Eldin Rammell, Director, Client Solutions at Phlexglobal

Eldin Rammell

Director, Client Solutions
Phlexglobal

10:20 am - 11:00 am The Solution Room

This interactive troubleshooting session is designed to give peer-supported advice and will target key eTMF challenges. Delegates and solution providers will split into small teams and take it in turns to present their biggest problem and have it brainstormed by the group to come up with solutions!

11:00 am - 11:30 am Networking Coffee Break

11:30 am - 12:10 pm Keeping your eTMF system and process contemporaneous by following a continuous improvement process (CIP) model

  • Look at the CIP as a system and understand how this evolves  as regulations and users change 
  • Develop your eTMF road map to ensure you have continuous system improvement 
  • Understand why it is crucial to have a good organisational change management system to avoid the ‘3 legged stool’ collapsing and causing disruption to your process

Jamie Toth, Head of TMF Operations at Daiichi Sankyo

Jamie Toth

Head of TMF Operations
Daiichi Sankyo

12:10 pm - 12:50 pm GDPR updates and developments impacting TMF & data governance

  • Gain complete comprehension of the European Protection Data Board (EPDB)’s opinions affecting clinical trials
  • Factor data privacy and data sharing into your TMF management
  • Establishing your own data governance systems that integrate GDPR requirements

Francis Crawley, Executive Director at Good Clinical Practice Alliance - Europe

Francis Crawley

Executive Director
Good Clinical Practice Alliance - Europe

12:50 pm - 1:50 pm Networking Lunch

Use this opportunity to benchmark with your peers and identify the key strategies required to optimize your eTMF process to ultimately ensure inspection readiness. Choose one round table and after 30 minutes rotate round to another topic area of discussion.
  • Identifying and addressing challenges and opportunities when implementing a new eTMF system
  • eTMF road mapping
  • Process change management in an electronic world 
  • Enablement and execution CRO approach to TMFs

Anne-Mette Varney, Trial Master File System and Process Manager at Novo Nordisk

Anne-Mette Varney

Trial Master File System and Process Manager
Novo Nordisk

Maria Nymann Jensen, Competency Development Professional at Novo Nordisk

Maria Nymann Jensen

Competency Development Professional
Novo Nordisk

Jamie Toth, Head of TMF Operations at Daiichi Sankyo

Jamie Toth

Head of TMF Operations
Daiichi Sankyo

Martina Duevel, Systems Excellence Project Leader at Bayer

Martina Duevel

Systems Excellence Project Leader
Bayer

Sarah Dean, Director, TMF Operations at Syneos Health

Sarah Dean

Director, TMF Operations
Syneos Health

Monica Alaimo, Director, TMF Operations at Syneos Health

Monica Alaimo

Director, TMF Operations
Syneos Health

2:50 pm - 3:30 pm How are digital trends making your eTMF system more advanced?

  • Gain insight on how you can use a modular e-learning platform to accelerate the way your company responds to your new eTMF system 
  • Develop a roll-out plan to take your eTMF system from being localised to being global to generate global oversight
  • Optimise your eTMF system by adding tracking and planning tools, on a global level, to immediately generate any inconsistencies in your system
Roman Widi, Unit Lead within the Regional Documentation Management Group at Boehringer Ingelheim Pharma RCV GmbH & Co KG

Roman Widi

Unit Lead within the Regional Documentation Management Group
Boehringer Ingelheim Pharma RCV GmbH & Co KG

3:30 pm - 4:10 pm Maintaining an accurate and complete eTMF systems across clinical trials to avoid delays in the inspection process

  • Address gaps in required documentation and learn how to avoid this in your trial 
  • Understand what documentation is required in your eTMF system to comply with regulations and ensure that it remains complete
  • Uncover lessons learned throughout Pfizer’s eTMF migration journey
Marie-Christine Poisson-Carvajal, Head of TMF Operations at Pfizer

Marie-Christine Poisson-Carvajal

Head of TMF Operations
Pfizer

  • Discuss how digital trends are going to influence the way we view eTMF
  • Evaluate your senior support structure to ensure a proactive method of working to get the most out of your eTMF platform 
  • Focus on the regulatory demands and gain clarity on how to maintain adaptation 

Jamie Toth, Head of TMF Operations at Daiichi Sankyo

Jamie Toth

Head of TMF Operations
Daiichi Sankyo

Martina Duevel, Systems Excellence Project Leader at Bayer

Martina Duevel

Systems Excellence Project Leader
Bayer

William Hamilton, Sr. Product Integrator, Life Sciences at DXC Technology

William Hamilton

Sr. Product Integrator, Life Sciences
DXC Technology

Cristina Laurie, Country Manager at TransPerfect

Cristina Laurie

Country Manager
TransPerfect

Oliver Pearce, Director of Commercialization at Montrium

Oliver Pearce

Director of Commercialization
Montrium

4:50 pm - 4:50 pm End of Day Two