9th Clinical Trials Inspection Readiness Summit 2020

Topics

• 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

Who should Attend

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