7th Clinical Trials Inspection Readiness Summit – 7th Clinical Trials Inspection Readiness Summit

Advisory Board

Jamie Bridges,
Director, Clinical Data Management,

Jonathan Rowe,
Executive Director and Head, Quality Performance and Risk Management,

Nancy Bitters,
GCP Inspection Lead,

As clinical trials are conducted, inspections ensure quality and integrity of care, data and drug performance. As sponsors for clinical trials, pharmaceutical companies are required to ensure GCP guidelines are upheld by implementing inspection readiness. These inspections are conducted by regulatory authorities, which all have unique regulations and caveats. These nuances make inspection readiness a difficult and resource-consuming battle. Clinical trials must be prepared for visits from countless stakeholders over their course. At the 7th Clinical Trials Inspection Readiness Summit, you will learn to improve inspection readiness and trial success through better documentation and operational standards.

Top Five Reasons to Attend

  1. Use different perspectives on inspection readiness to improve clinical operations and guarantee success
  2. Promote and ensure compliance with all regulatory agencies and their regulations using new systems and innovative methodologies
  3. Ensure trials are organized with improved oversight and communication to protect study participants’ rights, safety, and welfare
  4. Foster the intelligent design of clinical trial inspection readiness procedures by identifying trends that improve and encourage inspection readiness from past inspection metrics
  5. 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

This conference is designed for professionals from academia and pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:

  • Quality Assurance/Quality Control
  • Quality Compliance/Quality Management
  • Clinical Operations/Research/Planning
  • Outsourcing/Development
  • Records/Data Management
  • R&D Operations
  • Clinical Trials Management
  • Global Compliance
  • Risk-Based/Centralized Monitoring
  • Clinical Research
  • Safety and Risk Management Operations
  • Internal/External Auditing
  • Clinical Project Management
  • Trial Master Files
  • Clinical Documentation
  • Clinical Site Management
  • Global Regulatory Affairs
  • CAPA Auditing
  • Adverse Event Management
  • Metrics and Benchmarks
  • Process Optimization
  • Site Performance Management

The conference may also be of interest to the following:

  • CROs
  • Inspection Readiness Software Providers
  • Data/Records/Archive Management Vendors
  • TMF Vendors
  • Quality Management Service Providers
  • Electronic Signature Companies
  • Readiness Consultants

Photos from the 6th Clinical Trials Inspection Readiness Summit (August 2017):

Startdate: 2018-08-13
End Date 2018-08-14

Description: Improve and promote inspection readiness and document management in clinical research at the 7th Clinical Trials Inspection Readiness Summit.
Performer: ExL Events
Address : 7th Clinical Trials Inspection Readiness Summit