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

Conference Day One

9:15 am - 10:00 am 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

10:00 am - 10:45 am Mapping critical success factors for your inspection to ensure constant readiness

  • Ensure a successful inspection by learning how to study your metrics to make sure you’re inspection ready  
  • Learn to use a risk-based approach to prepare for inspections
  • Understand how your TMF fits into an inspection and why it’s use is crucial  to avoid slowing the process down
Gerard Barron, Director, Clinical Operations at Illingworth Research Group

Gerard Barron

Director, Clinical Operations
Illingworth Research Group

10:45 am - 11:30 am Speed Networking

A highlight of Pharma IQ events! Be ready to meet your peers and share best practices. You will have several 2 minute conversations to enable you to introduce yourself to your peers. There is a prize in it for the winner, so, get networking!
Please Share:
1. Who you are
2. The scope of your job role
3. What you plan to achieve from attending this event
4. Your #1 challenge

11:30 am - 12:00 pm Networking Coffee Break

12:00 pm - 12:45 pm Assuring regulatory compliance by implementing a centralised TMF oversight strategy in your organisation

  • Gain an enhanced understanding of the expectations of regulatory authorities 
  • Discover why it’s important to prioritise TMF oversight internally and how to implement this in your organisation
  • Understand what you can learn from conducting internal TMF oversight activities

12:45 pm - 1:15 pm Panel Discussion: Completeness in big pharma vs small pharma

  • Discuss how TMF systems vary between big pharma companies 
  • Learn what functional groups contribute to the TMF
  • Explore different methods used to maintain eTMF completeness and  evaluate which are most effective
  • Understand what is required to ensure that your eTMF is complete and ready for audit

1:15 pm - 2:15 pm Networking Lunch

2:15 pm - 3:00 pm Learn how to utilise your documentation during an eTMF transition, by assigning sponsor and CRO responsibilities

  • Discover how the TMF Exchange Mechanism can help solve interoperability issues in eTMF platforms
  • Identify the plans and processes that you can implement to ensure clear responsibilities  
  • Gain insight on the challenges that are faced by small sized pharmaceutical company as they go through an eTMF migration 
  • Benchmark your internal records management system and the challenges that lie within a sponsor and CRO relationship

Gertrud Rasmussen, Director of Clinical Operations at Zealand Pharma

Gertrud Rasmussen

Director of Clinical Operations
Zealand Pharma

3:00 pm - 3:45 pm Understand why strategy is crucial to demonstrating and ensuring eTMF completeness

  • Hear how you can use EDLs to ensure your eTMF is complete and in line with sponsor requirements 
  • The challenges to maintaining quality and timeliness whilst ensuring completeness
  • Identify ways you can motivate and support your team in the face of varying sponsor requirements for demonstrating completeness 
  • Learn why having a dedicated uploader can improve the quality of your system
Christopher Betts, Clinical Operations Manager, UK Country Head at DOCS

Christopher Betts

Clinical Operations Manager, UK Country Head
DOCS

3:45 pm - 4:15 pm Networking Coffee Break

4:15 pm - 5:00 pm An enablement and execution CRO approach to TMFs

  • Drive completeness in your eTMF process by using a TMF index to track your documentation milestones
  • Implement an oversight strategy and completeness checks to ensure your team are fulfilling TMF requirements
  • Hear the CRO perspective of the challenges that lie within sponsor and CRO relationships
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

5:00 pm - 5:30 pm Clarifying what documentation is needed in your eTMF system

  • Analyse what documentation is required to ensure your system remains complete and of high quality at all times
  • Address the fundamental challenges that were faced when IPSEN transitioned from a paper to eTMF system, and the key lessons that were learnt 
  • Identify the training processes that have proved successful to improve the mind-set of the different operational 
Dounia Sbai, Director, Quality Assurance at IPSEN Innovation

Dounia Sbai

Director, Quality Assurance
IPSEN Innovation

Catherine Boulard, Systems & Standards Manager at IPSEN Innovation

Catherine Boulard

Systems & Standards Manager
IPSEN Innovation

5:45 pm - 6:00 pm End of Day One

6:00 pm - 6:00 pm Networking Drinks Reception