16 - 19 September, 2019 | Pullman Brussels Centre Midi Hotel, Brussels, Belgium
Main Conference Day 1
9:00 am - 9:10 am Chairman's Opening Remarks
9:10 am - 9:50 am EU GCP Regulatory Inspections: The Regulators Perspective
- Dive deep into the differences between European Medicines Agency and National Inspections, to ensure you are prepared for every eventuality
- Analyse the European Medicines Agency Inspection process and discover what to expect
- Understand global GCP harmonization and international collaboration between regulators (EMA, FDA, PMDA etc.)
Patricia Giraldo
Quality Planning & Strategy (QP&S) Trial Oversight Specialist. Johnson & Johnson and (Former Scientific Officer at EMA Inspection Sector)Johnson & Johnson
9:50 am - 10:30 am Cross Industry Perspective: Understanding GCP with Respect to the Upcoming ISO DIS 14155:2018 for Medical Devices
- Analyse the changes that will be implemented following the 2020 revision of ISO DIS 14155:2018
- Draw comparisons between GCP for pharmaceutical clinical trials and medical device clinical trials
- Take home practical examples of how you can streamline your own approach to GCP with a clear understanding of regulatory expectations
Miloš Stojković
Senior Safety Specialist, Global Medical Affairs, Clinical, Scientific & Medical Affairs, Global R&DSmith & Nephew
10:30 am - 10:45 am PEOPLE BINGO
10:45 am - 11:15 am Morning Coffee Break
11:15 am - 11:55 am Preparing for Regulatory Change
- Understand the major implications of he transition from the 2001 Clinical Trial Directive and the 2014 Clinical Trial Regulation
- Gain insight into how you can prepare and incorporate these requirements into your current operational strategy
- Anticipating Brexit: Get a clearer understanding of how Brexit will affect your company and the future regulatory landscape
11:55 am - 12:35 pm Developing an Effective Risk Management Strategy that Works for Your Company
- Define the critical factors that must be considered when designing a QRM for a small company
- Personalise your approach to risk management by selecting the right tool
- Understand how risk management can be integrated as part of an inspection readiness programme
12:35 pm - 1:35 pm Networking Lunch
1:50 pm - 3:00 pm Break-Out Discussions
- Incorporating Metrics into Sponsor Oversight and the Tools Available
- Developing Best Practice Strategies for Inspections
- Designing Effective CAPA Reports
- Inspection Findings & Trends Post ICH GCP E6 (R2)
3:00 pm - 3:40 pm Quality Tolerance Limits – Setting Smart Parameters to Ensure Inspection Readiness
- Understand how Quality Tolerance Limits stipulated by the updated GCP guidance should be interpreted, and what it means to be compliant
- Analyze the benefits of Quality Tolerance Limits and what parameters should be considered for implementation
- Deep dive into how Quality Tolerance Limits can be implemented successfully with a case study from UCB and reflect on lessons learned
- Understand the potential impact of Quality Tolerance Limits on future regulatory submissions
3:40 pm - 4:10 pm Afternoon Coffee Break
4:05 pm - 4:45 pm An Enablement and Execution CRO Approach to TMFs
4:45 pm - 5:25 pm Clarifying What Documentation is Needed in Your eTMF System
5:35 pm - 6:35 pm Networking Drinks Reception
7:00 pm - 8:30 pm EVENING SOCIAL ACTIVITY (Offsite)
Meet at the Delirium Cafe - Impasse de la Fidelite 4, 1000 Bruxelles