– 8th Clinical Trials Inspection Readiness Summit

During the clinical trial process, sponsor organizations need to be prepared for regulatory authorities that conduct inspections to ensure that your process is meeting GCP standards. This year, we will focus on collaboration, considering CRO’s and clinical sites need to work with sponsors to pass inspections whether it is announced or unannounced.

The 8th Clinical Trials Inspection Readiness Summit is intended to arm attendees with strategies when designing and implementing a culture of preparedness. Through interactive sessions that discuss success strategies as well as the hardships that others have to deal with, you will have the opportunity to ensure you are properly prepared for your next inspection.



Top Five Reasons to Attend

  1. Use different perspectives of 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 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 is paramount and convert inspection readiness from a singular activity to an organizational culture for successful clinical trials

Conference Highlights:

  • 17+ expert speakers from various backgrounds including speakers from Daiichi Sankyo, EMD Serono, Pfizer, The Avoca Group, Yale School of Medicine, Takeda, Merck, and Bristol-Myers Squibb
  • Lessons Learned Segment featuring case studies presented by clinical inspection experts; these sessions will provide a new take on collaboration between speakers and attendees
  • Three panel discussions on the following topics: Inspection Readiness Throughout the Life Cycle; Global Inspection Readiness; and Lessons Learned From Other Countries
  • Take a deeper look at vendor oversight and collaboration to refine the relationship between stakeholders and foster a culture of readiness externally
  • Analyze quality management systems and how they can improve inspection readiness when operationalized and implemented efficiently

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
  • 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
  • Training, 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