The European Clinical Quality Oversight Forum
in London is the ONLY European event dedicated to risk-based approaches for selecting, managing and monitoring clinical vendors and sites.
This interactive event focuses on ensuring trial integrity by effectively assessing, optimising and managing the quality of clinical vendors and sites. It attracts clinical quality, operations, management and audit professionals who engage and candidly share their experiences, struggles, obstacles, and achievements when working with varying clinical partners including CROs and investigator sites. Learn from this experienced group and take-away proven, results-driven, risk-based strategies for optimising your company's clinical vendor and site oversight approach.
Top Five Reasons to Attend
- Learn from the industry's leading clinical operations and quality experts from around the globe, as they candidly share their experiences, strategies, and guidance for selecting and managing your clinical partners to ensure compliance and maximise performance.
- Benchmark your clinical quality oversight strategy against other similar-sized companies to ensure your approach is optimal and effective.
- Stay current on the changing GCP global regulatory environment and the impact on clinical compliance, quality, and operations.
- Integrate a risk-based, resource-optimising approach for effective selection, monitoring and long-term management of your clinical vendors and sites.
- Position your trial for success by ensuring your clinical vendors and sites are inspection-ready with the latest tools, technologies and audit strategies.
Who Should Attend:
This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:
- Quality Management/Clinical Quality Management
- Clinical Quality Assurance/QA/CQA
- Clinical Quality Control/QC/CQC
- Clinical Operations/Management/Research/Development
- Compliance/Clinical Compliance/Regulatory Compliance
- Monitoring/Site Management/Study Management
- Clinical Outsourcing/Vendor Management/Third-Party Management
- Good Clinical Practice/GCP
- Clinical Risk/Risk Assessment
- Regulatory Affairs
- Medical Affairs
The event is also of interest to:
- Investigative Sites
- Academic Research Organizations
- Central, Imaging and ECG Labs
- IVRS Companies
- EDC Companies
- Other Clinical Service Providers
We are currently shaping the agenda through research with industry professionals to identify current trends, areas of interest and common challenges so we can be sure the topics selected for sessions reflect the industry's needs and wants.
Topics we are considering for this year's program include:
- Interpreting and Aligning with ICH E6 R2
- Evaluating the impact of ICH E6 R2 on Oversight
- Understanding Quality Tolerance Limits and How to Develop Them
- Reviewing your Trial Master File from the MHRA Perspective
- Examining the impact of EU CTR
- Achieving a Confident State of Inspection Readiness
- Optimizing Data Integrity through Effective Oversight
- Executing Effective Risk-Based Monitoring
- Identifying Strategic Clinical Vendors
- Measuring the Clinical Quality of your Partners
- Managing Quality between Sponsors and CROs
- Initiating a Quality by Design Approach
- Prioritizing Data Quality to Proactively Identify Possible Noncompliance
- Overcoming Global Compliance Challenges
- Developing a Risk-Based Vendor and Site Audit Strategy
VenueHilton London Canary Wharf
South Quay, Marsh Wall
London, E14 9SH, UK
Set in the heart of London's commercial centre and only 15 minutes from the city centre via transportation links, Hilton London Canary Wharf is the ideal venue for business and leisure stays. Enjoy easy connections to London's main attractions, ExCel Exhibition Centre, The O2 and the Olympic Park.
To make reservations, guests can call +44 203 002 4300 and request the negotiated rate for GEXLA. To make reservations online Click Here
The group rate is available until 4 February 2019. Please book your room early, as rooms available at this rate are limited.