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

& 28-29 Sep 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 14 Feb

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 guideline.

This essential one-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 used in clinical trials.

This 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

An overview of risk management

  • Why risk management is important
  • Definitions of key risk management terminology
  • Brief overview of regulations and guidelines which cover risk management applied to clinical study-level risk management

Risk-based quality management system (QMS) – what does this really mean? How does it look?

  • What are the elements of a QMS which include risk?
  • What a regulatory inspector would expect to be in place for clinical trials
  • Group discussion on using a clinical QMS, including risk

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
  • Case study example

Brief review of risk-based approaches to QC/QA (auditing)

  • Example of best practice guide – RQA (Research Quality Association)

Final discussion

Presenter

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%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 14 Feb*
Enrol now
28-29 Sep 2020
28-29 Sep 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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