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
9:40 am - 10:20 am Understanding the Principles of Data Integrity
- 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 DirectorGood 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
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
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
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 DevelopmentPfizer
