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Risk Management for Clinical Research Training Course

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

Details

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.

Book now

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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
  • QED Clinical Services
  • 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 , Mar 19

All excellent - thank you!

Christine Henderson, Group Quality & Training Director, ADAMAS Consulting, Feb 18