This training program will discuss latest requirements for monitoring plans, content and process requirements including FDA monitoring guidance and EU requirements. The webinar will help, sponsors, and CROs in the US, EU and internationally, understand how to effectively draft monitoring plans and comply with the latest FDA and EU inspection requirements for monitoring clinical trials.
The webinar has been specifically designed to learn how to write and use monitoring plans, and generate a system for training and implementation of effective and compliant monitoring procedures. It will assist attendees prepare for inspection of monitoring plans. This knowledge is particularly important given the recent new regulatory requirements for monitoring plans in both the US and EU.
Why Should You Attend:
The FDA’s recent “Guidance for Industry Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring” requires for each clinical trial that the sponsor should develop a monitoring plan to describe the monitoring methods, responsibilities, and requirements of the trial. The EU EMA reflection paper 'Risk based quality management in clinical trials' (2013) also recommends that sponsors should prepare and maintain monitoring plans for all clinical trials.The webinar has been specifically designed to learn how to write and use monitoring plans, and generate a system for training and implementation of effective and compliant monitoring procedures. It will assist attendees prepare for inspection of monitoring plans. This knowledge is particularly important given the recent new regulatory requirements for monitoring plans in both the US and EU.
Areas Covered in the Webinar:
- Understand regulatory requirements for the creation, compliance, maintenance and revisions of monitoring plan
- Understand the FDA and EMA requirements for the components of a monitoring plan
- Implement compliant processes for monitoring plan requirements for clinical trials
- Gain insight into expectations for an effective monitoring plan documentation including non-compliance or revision of monitoring plans
- Understand roles and responsibilities of who should be involved in the monitoring plan process to ensure compliance with regulatory requirements
- Comprehend the latest FDA and EU expectations for monitoring plans
- Learn how training and implementation of the monitoring plan should be carried out to meet inspectors expectations
Who Will Benefit:
This webinar will provide critical assistance to those in FDA regulated companies including professionals in pharmaceutical, biotechnology, CRO, SMO, vendor companies, or study sites with investigator initiated studies that are subject to inspection or audit of their monitoring plans procedures, including those moving towards electronic monitoring plan.- Drug research and development managers and personnel
- Monitors
- Clinical research associates (CRAs)
- Clinical research archiving and document management personnel
- Clinical project managers
- Quality assurance managers and auditors
- Clinical development managers and personnel
- Phase I units
- CROs
- Project management
- Sponsors and non-commercial sponsors
- Sponsors who have their own laboratories for analyzing clinical trial samples
- Consultants
- Document management
- Legal, regulatory authorities and all other professionals who want to know more about inspection of monitoring plans
- Investigator sites
- Investigator initiated trials
Course Provider
Laura Brown,
