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

Conference Day One

8:30 am - 9:00 am Registration and Coffee

9:00 am - 9:10 am Chairwoman's Opening Remarks

9:10 am - 9:50 am eTMF and technology – An ever expanding landscape

  • Discuss the future of eTMF technology
  • Learn about new processes that may be streamlined and work towards greater efficiency
  • Hear how different technologies can be used to gain greater productivity – both short and long term
William Hamilton, Sr. Product Integrator, Life Sciences at DXC Technology

William Hamilton

Sr. Product Integrator, Life Sciences
DXC Technology

9:50 am - 10:30 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

10:30 am - 10:45 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

10:45 am - 11:15 am Networking Coffee Break

11:15 am - 11:55 am 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

Maria Nymann Jensen, Competency Development Professional at Novo Nordisk

Maria Nymann Jensen

Competency Development Professional
Novo Nordisk

Annebeth Jensen, Principal Competency Development Specialist at Novo Nordisk

Annebeth Jensen

Principal Competency Development Specialist
Novo Nordisk

  • 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

Christopher Betts, Clinical Operations Manager, UK Country Head at DOCS

Christopher Betts

Clinical Operations Manager, UK Country Head
DOCS

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

Liz Farrell, Associate Director at Biogen

Liz Farrell

Associate Director
Biogen

Rebecca Halbur, Senior TMF Manager at Biogen

Rebecca Halbur

Senior TMF Manager
Biogen

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

12:35 pm - 1:35 pm Networking Lunch

1:35 pm - 2:15 pm Breaking down silos with clinical operations, TMF operations and clinical quality - Creating an inspection readiness oversight model using the eTMF

  • Create CRO oversight review process and determine how to use eTMF system to document oversight for inspection readiness throughout the trial
  • Show how a global cross-functional team can break down silos and increase transparency to move towards consistency across therapeutic areas and phases
  • Work with CRO partners for input and implementation of oversight model
Ann McCabe, Director, Process Excellence & Risk Management, Clinical Development Operations at Daiichi Sankyo

Ann McCabe

Director, Process Excellence & Risk Management, Clinical Development Operations
Daiichi Sankyo

2:15 pm - 2:55 pm Perspectives from a biotech – Implementing an own eTMF system

  • Understand the reasoning’s why to change gear and go from a CRO hosted eTMF to an own hosted eTMF solution
  • Discover the criteria to select the ‘best fit’ solution
  • Gain insight on the challenges that are faced by small sized pharmaceutical company as they go through an eTMF migration
  • Identify the considerations for managing the records within a sponsor and CRO relationship

Gertrud Rasmussen, Director of Clinical Operations at Zealand Pharma

Gertrud Rasmussen

Director of Clinical Operations
Zealand Pharma

2:55 pm - 3:35 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

3:35 pm - 4:05 pm Networking Coffee Break

4:05 pm - 4:45 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

4:45 pm - 5:25 pm Lessons learnt from eTMF implementation and inspection readiness approach

  • 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

5:25 pm - 5:35 pm End of Day One

5:35 pm - 5:35 pm Networking Drinks Reception

7:00 pm - 7:00 pm Evening Activity: Delirium Café - Impasse de la Fidélité 4, 1000 Bruxelles