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

Main Conference Day 2

9:30 am - 9:40 am Chairman's Recap of Day 1 and Intro to Day 2

  • Understand the factors that must be considered when Implementing ALCOA+ data management systems
  • Define the roles of access control, computer validation, and metadata in ensuring data integrity
  • Ensure you maintain data integrity within European GCP frameworks and the GCP Inspectors’ expectations for data integrity
Francis Crawley, Executive Director at Good Clinical Practice Alliance – Europe & Strategic Initiative for Developing Capacity in Ethical Review

Francis Crawley

Executive Director
Good Clinical Practice Alliance – Europe & Strategic Initiative for Developing Capacity in Ethical Review

10:20 am - 11:00 am Case Study: Implementation of a New Global QMS in a Mid-Size Company and Lessons Learned

  • Define the steps that must be implemented before the new QMS goes live and how to achieve them
  • Analyse the compliance risk of implementing a new QMS and what to consider for inspection readiness
  • Reflect as Grunethal guides you through their experience following implementation and consider lessons learned
Elke Ufer, Global GxP QMS Manager, Global Quality Assurance at Grünenthal

Elke Ufer

Global GxP QMS Manager, Global Quality Assurance
Grünenthal

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

11:30 am - 12:30 pm Mini-Workshop: Operational Excellence to Improve Quality and Compliance related to Computerised Systems

  • Gain insight into lessons learned from a recent inspection, with respect to IT compliance
  • Develop a deeper understanding of the role of quality in IT compliance
  • Establish a task force group by aligning the internal standard for how to interpret regulatory requirements, including governance
  • Benchmark and discuss operational solutions for handling the expectations of authorities  
Caroline Sandström, Director GCP Compliance, Global QA, Development at Ferring Pharmaceuticals

Caroline Sandström

Director GCP Compliance, Global QA, Development
Ferring Pharmaceuticals

12:30 pm - 1:10 pm CRO Perspective: “Trust Us, we know what we are doing!” - Preparing for an MHRA Inspection

  • Deep dive into PPD’s preparation for their upcoming MHRA inspection
  • Discover PPD’s  strategy  for effective CAPA management, meeting the evolving expectations from Regulatory Agencies
  • Understand how CROs manage the Sponsor: Vendor relationship during an inspection and the challenges that arise during this time
Robrecht Tistaert, Senior Director Quality Strategy at PPD

Robrecht Tistaert

Senior Director Quality Strategy
PPD

1:10 pm - 2:10 pm Networking Lunch Break

2:10 pm - 2:55 pm Round Table Sessions - TMF

Use this opportunity to benchmark with your peers and identify the key strategies required to optimise 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

2:50 pm - 3:30 pm Maintaining an Accurate and Complete eTMF System Across Clinical Trials to Avoid Delays in the Inspection Process




Marie-Christine Poisson-Carvajal, Head of TMF & Registry Operations, Clinical Development Quality, Global Product Development at Pfizer

Marie-Christine Poisson-Carvajal

Head of TMF & Registry Operations, Clinical Development Quality, Global Product Development
Pfizer

3:30 pm - 4:10 pm How are Digital Trends Making Your eTMF System More Advanced?

Roman Widi, eTMF Unit Lead Regional Centre at Boehringer Ingelheim

Roman Widi

eTMF Unit Lead Regional Centre
Boehringer Ingelheim

4:10 pm - 4:50 pm Summative Discussion: What’s the Future for eTMF?

Jamie Toth, Head of TMF Operations at Daiichi Sankyo

Jamie Toth

Head of TMF Operations
Daiichi Sankyo

5:50 pm - 6:00 pm Chairman's Closing Remarks

5:00 pm - 5:30 pm Final Coffee and Goodbyes