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