Risk Based Approaches for Clinical Trials
Instructor:
Laura Brown
Product ID: 705858
- Duration: 90 Min
Why Should You Attend:
FDA and EMA have communicated their expectations for trial oversight/ monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations: A Risk- Based Approach to Monitoring and the EMA Reflection Paper on risk-based quality management in clinical trials both of which will be reviewed in this web seminar.
Areas Covered in the Webinar:
- Key risk based process/tools and techniques
- Review a risk based approach to protocol design
- Understand risk based approach to monitoring/data handling
- Best practice of these new risk requirements
Who Will Benefit:
- Clinical Development Managers and Personnel
- Clinical Research Archiving and Document Management Personnel
- Quality Assurance Managers and Auditors
- Consultants
- Regulatory Affairs Specialists
- Pharmacovigilance /Drug Safety
- Study Site Personnel
Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development
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 and risk based monitoring. 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).
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