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

With the pharmaceutical regulatory environment constantly evolving, it is extremely important to always be prepared for an inspection during a clinical trial. As sponsors of clinical trials, pharmaceutical companies are required to ensure GCP guidelines are upheld by implementing inspection readiness. Inspections are a crucial part of clinical trials, and it is extremely important that all companies are ready and properly follow GCP guidelines. Inspections are an ongoing process involving all stakeholders, and the real question is how/what can you do in your organization to reduce the frequency of inspections? By properly preparing for inspections, adopting and understanding all the requirements, and having good documentation and data management, companies will have a better chance of warding off inspections and have successful outcomes their trials.

The conference has grown over the past few years, and 2018 will expand on new topics, case studies and featured panel discussions. Don’t miss out on the 7th Clinical Trials Inspection Readiness Summit on August 13–14 in Philadelphia to learn how to maximize inspection readiness and trial successes through better documentation and operational standards.

Conference Co-Chairs


Grace Crawford,
VP Clinical Quality and Compliance,
MEDIMMUNE

Katherine Taylor,
Director, GCP Inspection Management,
MERCK

 

Featured Speakers

 

Top Five Reasons to Attend

  • Explore different perspectives on inspection readiness to improve clinical operations and guarantee success
  • Analyze how to better prepare for inspections and outline the most important factors in maintaining a successful inspection readiness
  • Discuss the impact and aligning of ICHE6 R2 to ensure compliance and risk management
  • Implement the culture of inspection readiness and understand how to successfully improve clinical quality to ensure better documentation management
  • Review the BlMO realignment and truly understand adopting and living according to new regulations

 

PAST ATTENDEES SNAPSHOT


 

Who Should Attend

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

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

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