Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans 2015

Key Topics

• The FDA and EMA requirements for the components of a monitoring plan
• Regulatory requirements for the creation, compliance, maintenance and revisions of monitoring plan
• Expectations for an effective monitoring plan documentation including non-compliance or revision of monitoring plans
• Compliant processes for monitoring plan requirements for clinical trials
• The latest FDA and EU expectations for monitoring plans
• Roles and responsibilities of who should be involved in the monitoring plan process to ensure compliance with regulatory requirements
• How training and implementation of the monitoring plan should be carried out to meet inspectors expectations

Who should Attend

• Monitors
• Drug research and development managers and personnel
• Clinical research archiving and document management personnel
• Clinical research associates (CRAs)
• Quality assurance managers and auditors
• Clinical project managers
• Phase I units
• Clinical development managers and personnel
• Project management
• CROs
• Sponsors who have their own laboratories for analyzing clinical trial samples
• Sponsors and non-commercial sponsors
• Document management
• Consultants
• Investigator sites
• Legal, regulatory authorities and all other professionals who want to know more about inspection of monitoring plans
• Investigator initiated trials