Why Should You Attend:
Risk management is becoming increasingly important to running clinical trials particularly with Covid-19. There are now numerous pharmaceutical guidelines covering risk assessment and management and Risk Based Monitoring (RBM). Risk assessment of clinical trials is particularly important with the emerging coronavirus (COVID-19) situation which is increasingly impacting clinical trials. There are guidances from FDA, EMA and industry associations which provide recommendations for managing clinical trials during Covid-19 with emergency interim measures during this period to ensure that data quality from clinical trials is unaffected, clinical trial sites are supported and that the patients enrolled in clinical trials are kept safe.
This session will explain the key requirements for risk management of clinical trials to comply with the latest focus on GCP inspection in this area including during the challenging environment of COVID-19.
This essential web seminar will explain the importance of using risk management techniques including the impact of Covid-19 to comply with the latest focus on GCP inspection in this area. It will show you how risk management including RBM can improve the quality of your clinical trials and demonstrate the importance of using RBM, risk analysis and risk management techniques in clinical trials. You will learn how to identify, evaluate and also how to implement specific risk-based techniques for risk management used in clinical trials including during Covid-19. This session will provide guidance on the latest FDA and EMA thinking on risk management of clinical trials to meet inspectors’ expectations.
Areas Covered in the Webinar:
Who Will Benefit:
Anyone working on clinical trials including
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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