Compliance for Risk Based Approaches for Clinical Trials 2018 is a webinar that covers topics such as:
- The regulations and guidelines which cover risk management applied to clinical study - level risk management
- The new requirements for risk management in clinical trials
- Have explained key based process/tools and techniques
- The elements of QM system are and what a regulatory inspector would expect to be in place for clinical trials
- Risk based approach to monitoring/data handling
- A risk based approach to protocol design
- Best practice of these new risk requirements
Compliance for Risk Based Approaches for Clinical Trials 2018 is intended for:
- Monitors
- Clinical Research Associates (CRAs)
- Project Managers
- Clinical Managers
- Data Managers and Statisticians
- Lead Clinical Research Associates
- Clinical Development Managers and Personnel
- Study Managers, Document Management
- Quality Assurance Managers and Auditors
- Clinical Research Archiving and Document Management Personnel
- Regulatory Affairs Specialists
- Consultants
- Study Site Personnel
- Pharmacovigilance /Drug Safety
