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

Duration: 60 Minutes
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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  • 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
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Laura Brown, PhD, MBA, Diploma Clinical Sciences is an independent QA and Training Consultant in the Pharmaceutical Industry, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20year's experience of running clinical trials and clinical quality assurance in the pharmaceutical industry.

Laura Brown has held a number of international and senior management QA positions in the pharmaceutical industry including as an Associate Director with a leading GCP audit consultancy. She has worked for several international companies including GSK, Hoechst Marion Roussel and Phoenix International.

Laura is author of a chapter on "Training QA staff" in the leading GXP book: "Good Clinical, Laboratory and Manufacturing Practices". She is author of SCRIP's latest GCP guide and a "Practical Guide to the Clinical Trial Directive, a chapter on International Drug Development, Impact of Brexit, and several articles on the new EU Clinical Trails Regulation. She is also co-author of several books including "Developing the Individual" and "Project Management for the Pharmaceutical Industry". She has regularly lectured at conferences and on training courses on QA and GCP issues.

Laura developed an e-learning module: "How to Prepare for Audit and Inspection" for Zenosis (A regulatory commercial e-learning training organization) and an e-learning GXP SOP series for Henry Stewart Conferences.

Laura runs many training courses both on public courses and in-company on topics including: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, clinical trial regulations, the new ICH GCP R2 guideline, managing clinical trials, QA Management and business skills, how to prepare for audit and inspection.
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