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Risk Based Monitoring for GCP Compliance
- Understand the new requirements for risk-based monitoring in clinical trials
- Define the regulations and guidelines which cover risk-based monitoring
- Review of risk-based monitoring approaches and methodology for clinical trial projects
- Learn how to identify and evaluate risks for the investigator site and protocol for implementing risk-based monitoring
- Learn how to identify critical data
- Evaluate the risk indicator and set thresholds
- Consider how to implement this new concept within your organization
- Hear best practice of these new risk requirements
Overview of the webinar
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 support 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 training 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. 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
Who should attend?
- 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
Why should you attend?
- 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
Faculty - Dr.Laura Brown
Dr. Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.
Dr. Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).