Risk Management in Clinical

Speaker:Jane Tucker

After issuance of the guidance document ICH Q9 – Quality Risk Management in 2006, there was an expectation that every discipline within the pharmaceutical industry will be able to take a ‘risk based approach’ to every activity, including clinical trial management. Risk management needs to be a holistic and systematic approach to ensure successful completion of trials/projects.

What does this mean in practice?

Effective risk management needs effective risk identification, assessment, planning, tracking and controlling. Risks are dynamic and therefore risk management process needs to be supported by sophisticated risk management tool designed to facilitate end to end process to have better control over trial/program. Considering the importance of risk management in efficient management of clinical trials, this webinar will provide more insight on:

  • Risk management methodology foundation
  • Basic principles to take a ‘risk-based approach’ for clinical trial
  • Documentation of risk management
  • Prioritise risks and plan mitigation actions where necessary
  • Tools utilization for effective management & automation

Who should attend?

  • Clinical Operations
  • Project Managers
  • Quality Assurance
  • Risk & Compliance Managers