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Risk Management for Clinical Research

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

23-24 Mar 2020

& 28 Sep 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

Risk management is becoming increasingly important to running clinical trials and ensuring compliance with regulatory expectations. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9 and the revised ICH GCP R2.

This essential two-day course will explain the importance of using risk management techniques in clinical research to comply with the latest focus on 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 and risk-based monitoring. You will learn how to identify, evaluate and implement specific risk-based techniques for risk management, including a clinical quality management framework.

The course will enable you to develop quality risk management principles applicable to clinical research, as well as to identify and share best practices for implementing risk management tools and approaches.

Benefits of attending:

  • Understand risk management tools and when and how the tools are used in clinical research projects
  • Learn how to plan risk-based approaches, how to document and where to focus to meet regulatory requirements and expectations
  • Develop and apply risk management principles and tools to your clinical trials, including risk-based monitoring
  • Identify and share best practices for implementing risk-based tools and principles

Who should attend?

Anyone working on clinical trials including CRAs, monitors, clinical managers, project managers, lead clinical research associates, data managers, statisticians, study managers and those in QA/audit/QC and document management. It will also be relevant to those who work alongside the study team, such as regulatory affairs and pharmacovigilance.

Programme - Day one

Risk-based concepts and terminology

  • Background and concepts to the risk management regulatory drive as applied to clinical trials
  • Key risk management definitions and terminology
Outline of industry guidance and regulatory expectations
  • What are the key ICH, FDA, EMA, MHRA regulations/guidelines, including:
    • ICH Q9, CH E6 R2, EU Clinical Trial Regulation and EMA good practice guide on risk minimisation and prevention of medication errors
Importance and benefits of risk management
  • How is risk management applicable to clinical research, pharmacovigilance and regulatory affairs?
  • Why is formal risk management important in EU, US and internationally?
  • Benefits of using a risk management approach
Risk management process
  • How to identify and evaluate risk
  • How to control risk
  • Communicating and reviewing risks
  • How to report risk
New proposed ICH risk-based quality management system (QMS) for clinical trials
  • What does this really mean and how does it look?
  • Clinical QMS framework
    • What are the elements of a clinical QMS which include risk?
    • What would a regulatory inspector expect to be in place for clinical trials?

Programme - Day two

Risk-based processes/tools and techniques
  • Examples of risk management processes
  • Risk-based tools including:
    • Root cause analysis
    • Risk breakdown structure
    • Risk log
    • Failure modes and effects analysis (FEMEA)
    • Risk matrix
    • Examples of pharmaceutical risk tools for clinical trials including RACT (Risk Assessment Categorization Tool)
Risk-based approach to the protocol
  • Quality by design (QbD) applied to the protocol
  • How this is being applied to the design of protocols
Risk-based approach to monitoring
  • Different approaches to risk-based monitoring and examples of how this is carried out
  • Discussion of what approaches and documents are used
  • Centralised monitoring
  • Quality tolerance levels
  • Case study example
    • FDA latest question and answers guidance
Brief review of risk-based approaches to QC/QA (auditing)
  • Example of best practice guide – RQA (Research Quality Association)


Laura Brown

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

Continuing professional development

This course qualifies for the following CPD programmes:

  • CPD certificate of attendance

Book now

23-24 Mar 2020
23-24 Mar 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
28 Sep 2020
28 Sep 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • ADAMAS Consulting
  • AiCuris Anti-infective Cures GmbH
  • Bracco Imaging S.p.A.
  • Cancer Research UK
  • Cook Medical
  • Dermal Laboratories Ltd
  • GE Healthcare Ltd
  • Glenmark Pharmaceuticals
  • GW Pharmaceuticals
  • Institut de Recherches Internationales Servier
  • JT International
  • Laboratoires SMB
  • Leo-Pharma A/S
  • medac GmbH
  • Mitsubishi Tanabe Pharma Europe Ltd.
  • Novo Nordisk A/S
  • ObsEva Sa
  • Opiant Pharmaceuticals
  • Sanofi Aventis Recherche & Développement
  • Summit Therapeutics
  • University of Sydney and Westmead Hospital

Very interesting training, excellent for a clear and well structured introduction to Risk Management in Clinical Research.

Myriam Mouhib, Clinical Assessment Manager, JT International

All excellent - thank you!

Christine Henderson, Group Quality & Training Director, ADAMAS Consulting