24 - 27 September, 2018 | Postillion Convention Centre, Amsterdam, Netherlands

Conference Day One

8:30 am - 8:55 am Welcome Coffee and Registration

8:55 am - 9:00 am PharmaIQ Welcome

9:00 am - 9:15 am Chairman's Opening Remarks

Eldin Rammell - Managing Director, Rammell Consulting
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Eldin Rammell

Managing Director
Rammell Consulting

9:15 am - 10:00 am Success in Optimising TMF Management

Tony Nguyen - Head of TMF Operations, GRAIL
- Understand how to define the right strategy in optimising records management
- Learn how to define inspection readiness in a SME
- Hear how new technologies are determining the way TMF is managed across partners
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Tony Nguyen

Head of TMF Operations
GRAIL

10:00 am - 10:30 am Location, Location, Location: Ensuring TMFs are “SPOT” On (SPOT= Single Point of Truth)

Patricia Santos-Serrao - Director, Clinical and Regulatory Solutions, MasterControl
It’s no secret that technology is playing a significant part in the management of clinical study information. Different systems bring different features and functionality for managing the various aspects from case report form, to adverse events, and monitoring visit reports to audit management, the growing list of tools to manage aspects of a study can result in dispersed information across various systems.  The objective of this session is to:
 
  • Identify the variety of technology solutions used in clinical research and the role and value of these tools
  • Highlight the common data captures in these systems and the data points commonly shared across these systems
  • Share the value of a “single point of truth” for both internal and external parties
  • Provide some insight into tips to address the gaps, and the use of “signposts” to provide a single point of truth for TMF
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Patricia Santos-Serrao

Director, Clinical and Regulatory Solutions
MasterControl

10:30 am - 11:00 am Coffee Break

- Provide an overview of the Exchange Mechanism Standard and the vision of the project
- Discuss how the standard may be leveraged to solve interoperability issues
- Provide an update on status and adoption by eTMF vendors
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Paul Fenton

TMF Reference Model Steering Committee Member and eTMF-EMS Sub-group Co-chair
TMF Reference Model

11:40 am - 12:20 pm Vendor Spotlight - Welcome to the Dragon’s Lair!

This interactive session packs both fun and targets key challenges into a troubleshooting session
 
Delegates and solution providers will split into teams and conceptualise, research and create a brand new product to help with their eTMF challenges. Once formed each team’s idea will be presented to a team of industry judges, who will vote for the best idea! 

12:20 pm - 1:20 pm Networking Lunch

1:20 pm - 2:00 pm Best Practice in TMF Management at a Study Level

Jamie Toth - Head of TMF Operations, Daiichi Sankyo
- Hear how the new TMF management tool gives guidance on managing TMFs throughout a study
-Determine the different factors that need continuous consideration
-Predict how future technologies and eTMF platforms will change the way we prepare for inspection
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Jamie Toth

Head of TMF Operations
Daiichi Sankyo

2:00 pm - 2:40 pm TMF Innovation Showcase

Meet with a select few TMF solution providers to hear the latest innovation in eTMF platforms and methods for process optimisation

2:40 pm - 3:10 pm Afternoon Coffee Break

3:10 pm - 4:30 pm Afternoon Round Table Sessions

After a day of presentations and debates, use this opportunity to discuss with your peers the key strategies in optimising TMF process for inspection readiness, Choose one round table and after 30 minutes rotate round to another topic area of discussion.

Choose your Session
  1.  Improving visibility of TMF management between CROs and Sponsors
  2. How to transfer data from on to another electronically in eTMF format
  3. TMF Contents Review for Inspection Readiness
  4. How are we dealing with the digital revolution
  5.  Quality metrics of eTMF 

4:30 pm - 5:10 pm The Roadmap to Implementation – What Will Your Journey Actually Look Like?

Vittoria Sparacio - Head, Clinical Documentation Operations, GSK

·Manage your in-house transition- the journey to system implementation and the realities of resourcing
·Maximise your implementation strategy by addressing your team culture – how should your team be working and how you can achieve this
·Understand the timeline to implementation and prepare for pitfalls and challenges along the way – what GSK learned from their implementation and how you can avoid the same challenges
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Vittoria Sparacio

Head, Clinical Documentation Operations
GSK

5:10 pm - 5:20 pm Chairman’s Summary of Day One

Eldin Rammell - Managing Director, Rammell Consulting
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Eldin Rammell

Managing Director
Rammell Consulting