The 9th Clinical Trials Inspection Readiness Summit 2020 covers topics such as:
- Compliance with all regulatory agencies and their regulations using new systems and innovative methodologies
- Different perspectives on inspection readiness to improve clinical operations and guarantee success
- Intelligent design of clinical trial inspection readiness procedures - identifying trends that improve and encourage inspection readiness from past inspection metrics
- Ensure trials are organized with improved oversight and communication to protect study participants’ rights, safety and welfare
- Assure quality and compliance are paramount, and convert inspection readiness from a singular activity to an organizational culture for successful clinical trials
The 9th Clinical Trials Inspection Readiness Summit 2020 brings together professionals from academia and medical device, pharmaceutical and biotechnology companies with responsibilities in:
- Quality Compliance/Quality Management
- Quality Assurance/Quality Control
- Outsourcing/Development
- Clinical Operations/Research/Planning
- R&D Operations
- Records/Data Management
- Global Compliance
- Clinical Trials Management
- Clinical Research
- Risk-Based/Centralized Monitoring
- Internal/External Auditing
- Safety and Risk Management Operations
- Trial Master Files
- Clinical Project Management
- Clinical Site Management
- Clinical Documentation
- CAPA Auditing
- Global Regulatory Affairs
- Metrics and Benchmarks
- Adverse Event Management
- Site Performance Management
- Process Optimization
Also:
- Inspection Readiness Software Providers
- CROs
- TMF Vendors
- Data/Records/Archive Management Vendors
- Electronic Signature Companies
- Quality Management Service Providers
- Readiness Consultants
