Presented by
Management Forum

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

Find out more

  • Format: Bespoke training
  • CPD: 6 hours for your records (depending on your requirements)
  • Certificate of completion

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 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.

Laura Brown

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA. She has more than 19 years’ experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing and has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Good Clinical Practice Journal. She is co-author of several books on management including ‘Developing the Individual’, 'The Ultimate Book of Business Skills’ and ‘Pharmaceutical Project Management’.

More details

We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

See below or contact us to discuss yor requirements.

Reviews of IPI's Risk Management for Clinical Research training course


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

Mar 28 2019

Myriam Mouhib
Clinical Assessment Manager, JT International

Feb 26 2018

All excellent - thank you!

Christine Henderson
Group Quality & Training Director, ADAMAS Consulting

UK

  • ADAMAS Consulting
  • Cancer Research UK
  • Dermal Laboratories Ltd
  • GE Healthcare Ltd
  • Glenmark Pharmaceuticals
  • GW Pharmaceuticals
  • Mitsubishi Tanabe Pharma Europe Ltd.
  • Opiant Pharmaceuticals
  • Summit Therapeutics

Denmark

  • Cook Medical
  • Leo-Pharma A/S
  • Novo Nordisk A/S

France

  • Institut de Recherches Internationales Servier
  • Sanofi Aventis Recherche & Développement

Germany

  • AiCuris Anti-infective Cures AG
  • medac GmbH

Switzerland

  • JT International
  • ObsEva Sa

Australia

  • University of Sydney and Westmead Hospital

Belgium

  • Laboratoires SMB

Italy

  • Bracco Imaging S.p.A.

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy