European Clinical Trials Inspection Readiness Summit – European Clinical Trials Inspection Readiness Summit

Inspection readiness is a constantly evolving set of processes that must be in place in order to ensure an inspection can be given immediate and complete access to clinical trial records. Sponsor companies need to be at the helm of the effort to remain compliant — which is a huge burden to bear.

Sponsor companies must evaluate potential clinical trial partners, define clear responsibilities for each stakeholder and attain top-notch document quality, at the same time ensuring that all relevant information is accessible to inspectors whenever they may arrive. Anything less than complete GCP compliance can result in heavy fines and a loss of reputation in the market.

The European Clinical Trials Inspection Readiness Summit provides life science industry professionals with lessons learned by industry speakers who have firsthand experience. Delegates will leave the event armed with best practices in partner oversight and metrics, data quality, legacy system interoperability, risk assessment tools, a better understanding of what health authorities command, and the confidence needed to bring SOPs to the table for company-wide implementation.

Top Five Reasons to Attend

  1. Review crucial information and analyze regulations from around the world, with a focus on FDA, EMA, PMDA and MHRA regulations
  2. Benchmark the success of clinical trials with relevant metrics for measuring the performance of CROs and trial sites
  3. Learn strategies to ensure comprehensive clinical trial storyboarding to help inspectors recreate the trial through these vital documents
  4. Leverage process maps that can be applied to streamline TMF management and the key team members who need to be involved
  5. Innovate your inspection-readiness SOPs armed with information on risk-based modeling for inspection readiness

Who Should Attend

This conference is of interest to professionals from pharmaceutical, biotechnology and medical device companies with responsibilities involving:

  • Quality Assurance/Quality Control/Quality Compliance/Quality Management
  • Clinical Operations
  • Records/Data Management
  • Clinical Trials Management
  • Global Compliance
  • Clinical Monitoring
  • Clinical Research
  • Safety and Risk Management/Operations
  • Auditing
  • Clinical Project Management
  • Trial Master Files
  • Clinical Development
  • Clinical Document Coordinator
  • Clinical Site Management
  • Global Regulatory Affairs

This event is also of interest to:

  • CROs
  • Inspection Readiness Consultants
  • Data & Records Management Vendors
  • TMF Solution Providers