Clinical Study Risk Management including Compliance During The COVID-19

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.

Learning Objectives:

• Understand risk management tools including for RBM and when and how the tools are used in clinical research projects including the impact of FDA and EMA requirements during Covid-19.
• How to plan risk-based approaches for clinical trials including during Covid-19
• How to document risks management and RBM
• Where to focus to meet regulatory requirements and expectations for risk management including RBM during Covid-19
• Develop and apply risk management principles and tools to your clinical research projects
• Review best practice of these additional new risk management requirements during Covid-19

Areas Covered in the Webinar:

• Understand the new requirements for risk management in clinical trials including the latest EMA and FDA guidance on risk management during Covid-19
• Define the regulations and guidelines which cover risk management and Covid-19 applied to clinical study-level risk management
• Consider the elements of QM system are and what a regulatory inspector would expect to be in place for clinical trials
• Have explained key risk-based process/tools and techniques including RBM and FDA and EMA recommendations during Covid-10
• Review a risk-based approach to protocol design
• Hear best practice of these new management risk requirements during Covid-19

Who Will Benefit:

Anyone working on clinical trials including

• Clinical QA
• clinical managers
• project managers
• lead clinical research associates
• CRAs
• data managers and statisticians
• study managers
• Clinical Research Archiving and Document Management Personnel
• Quality Assurance Managers and Auditors
• Clinical Development Managers and Personnel
• 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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