3rd European Clinical Trials Inspection Readiness Summit – 3rd European Clinical Trials Inspection Readiness Summit

An inspection from the FDA can pop up at any time throughout a clinical trial pipeline, and being prepared is key. The industry must move toward innovative methods and utilize new technologies to ensure compliance in a global environment. Change your inspection readiness strategy into one that is proactive and preventative, instead of one that is mainly concerned with putting out fires. Developing effective strategies for risk management through careful vendor selection and oversight, expert knowledge of FDA guidances, budget management, and TMF and pharmacovigilance audits will put your organization ahead of the pack.

The 3rd European Clinical Trials Inspection Readiness Summit is designed to explore best practices for developing and maintaining compliance at clinical trial inspection sites. Delegates will leave the event armed with strategies regarding partner oversight, metrics, data quality, TMFs and risk assessment tools. Additionally, this event will provide opportunities for sharing best practices and networking across all contributors and stakeholders, including sponsors, regulators, CROs and project teams.

Top Five Reasons to Attend

  • Review crucial information and analyze regulations from around the world, with a focus on FDA, EMA, PMDA and MHRA regulations
  • Benchmark the success of your clinical trial using metrics that measure the performance of CROs and trial sites
  • Learn strategies for ensuring there is a comprehensive clinical trial storyboard so inspectors can recreate the trial
  • Leverage process maps that can be applied to streamline TMF management and the key team members who need to be involved
  • Innovate your inspection readiness SOPs armed with information on risk-based modeling for inspection readiness

Who Should Attend

This conference is designed for professionals from pharmaceutical, biotech, medical device and clinical research entities with responsibilities in the following areas:

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

This program is also of interest to clinical QA/compliance professionals involved with:

  • Institutional Review Boards
  • Investigative Sites
  • Data Management/Computer Software
  • Consulting Firms