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

  • 29 May 2015
  • Webinar

Description

Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans 2015 is a webinar that covers topics such as:

  • 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

Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans 2015 is intended for:

  • 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

Past Events

Important

Please, check "Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical laboratories, Medical technology, Pharma
Science: Life Sciences & Biology

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