Risk Management in Clinical Trials: What will inspectors look for?

Duration: 60 Minutes
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Risk management is becoming increasingly important to running clinical trials. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, the revised ICH GCP guideline, recently released EU Clinical Trial Regulation guideline on risk management and several other risk management clinical research standards and initiatives.
Risk Management in Clinical Trials
Instructor: Laura Brown
Product ID: 506955
Objectives of the Presentation
  • Understand risk management tools and when and how the tools are used in clinical research projects
  • How to plan risk based approaches for clinical trials
  • How to document risks
  • Where to focus to meet regulatory requirements and expectations for risk management
  • Develop and apply risk management principles and tools to your clinical research projects
  • Consider best practices for implementing risk based tools and principles
  • Review best practice of these additional new risk management requirements
Why should you Attend
This essential webinar will explain the importance of using risk management techniques in Clinical Research to comply with the latest focus on GCP inspection in this area. It will show you how risk management can improve the quality of your clinical trials and demonstrate the importance of using risk analysis and risk management techniques in clinical trials. You will understand how to identify, evaluate and also how to implement specific risk based techniques for risk management used in clinical trials.

Areas Covered
  • Understand the new requirements for risk management in clinical trials
  • Define the regulations and guidelines which cover risk management 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
  • Review a risk based approach to protocol design
  • Understand risk based approach to monitoring / data handling
  • Review of risk based approaches to QC / QA (Auditing)
  • Hear best practice of these new risk requirements
Who will Benefit
  • Clinical Development Managers and Personnel
  • Clinical Research Associates
  • 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
$375
Recorded Session for one participant
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials.
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