Risk Based Clinical Trial Monitoring
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This webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
Why Should you Attend
It is essential to comply with the latest GCP requirements to have a risk based monitoring methodology for your clinical trials. It is also essential to have a quality risk management system in place to allow for risk based monitoring. The FDA and EU regulatory authorities supports clinical trial sponsors to use risk-based site monitoring. For example, the revised ICH GCP guideline R2 Addendum, the EU Clinical Trial Regulation and FDA monitoring guideline all cover risk based monitoring.
This webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
Objectives of the Presentation
- FDA’s inspectional programs
- Relevant risk factors for inspection selection
- The FDA’s inspectional procedures
- Your inspectional plan and protocol
- Interacting with the FDA / Human Factors
- What not to do during an inspection
This webinar will explain:
- The rationale for risk based monitoring
- The requirements for risk-based monitoring and targeted source data verification (SDV) risks identification
- Critical data and risk indicators analysis
- The monitoring plan including risk monitoring and centralized monitoring
- How to use risk based assessment for investigational sites and the protocol to implement risk based monitoring
- Risk based monitoring roles and responsibilities
- Define risk based monitoring for clinical trials
- Understand risk based monitoring tools and methodology used in clinical research projects
- Explore the roles and responsibilities of those involved in risk based monitoring
- How to plan risk based monitoring approaches for clinical trials
- Understand how to identify and evaluate study site and protocol risks for targeted SDV
- Develop and apply risk monitoring in your clinical trials
- Learn how to document risk based monitoring in the monitoring plan
Who will Benefit
The session is relevant for professionals working in pharmaceutical, biotechnology, CRO, regulatory authorities and study sites including investigator initiated studies involved in clinical trials. It will also be of interest to those departments who liaise/support clinical trial personnel such as:
- Clinical Development Managers And Personnel
- Clinical Operations Personnel
- Clinical Research Associates
- Clinical Research Archiving and Document Management Personnel
- Quality Assurance Managers and Auditors
- CROs using Laboratories to Analyze Clinical Trial Samples
- Project Management
- Sponsors and Non-Commercial Sponsors
- Consultants
- Laboratories Analyzing Samples from Clinical Trials
- Regulatory Affairs Personnel
- Legal and Regulatory Authorities
Instructor Profile:
Laura Brown
Dr Laura Brown is an independent pharmaceutical QA and training consultant and the Course Director for the MSc Clinical Research, School of Pharmacy, University of Cardiff. Laura is an expert in outsourcing pharmaceutical research projects including CRO selection, audit and management. She has more than 20 years’ experience in the pharmaceutical industry in a number of senior roles and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International in outsourcing pharmaceutical projects. She has worked in several vendor selection and management roles which have included reviewing quality and performance of CROs and has advised companies on how to implement quality systems for CRO selection and management.
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Additional information
| Purchase Options | Live Access, Recorded Access, Training CD/DVD, USB Flash Drive, Live+Recorded Access, Live Access+CD/DVD, Live Access+USB Flash Drive |
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