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Risk Management for Clinical Research Training Course

This essential course will explain the importance of using risk management techniques in clinical trials to comply with the latest focus on inspection in this area.

★★★★★ "Very good"

4 February 2025
+ 6 June 2025, 7 October 2025 »

from £649

Need help?  Enrol/reserve

Course overview

Risk management is becoming increasingly important in clinical trials, as well as in ensuring compliance with regulatory expectations. Numerous pharmaceutical guidelines now cover risk management in clinical trials, including ICH GCP R2 and R3, and the FDA's Risk-Based Monitoring of Clinical Investigations: Questions and Answers guidance.

During this one-day course you will learn how to apply a risk-based approach when managing your clinical trials lifecycle. We will review the principles of risk management and how to apply them within a clinical trial setting according to ICH GCP R2 and R3.

This essential course will explain the importance of using risk management techniques in clinical development 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 research projects and demonstrate the importance of using risk analysis and risk management techniques in clinical trials. You will learn how to identify, evaluate and implement specific risk-based techniques for risk management, including a quality management framework.

The course will enable you to develop quality risk management principles applicable to clinical trials, pharma, biopharma and device development, as well as to identify and share best practices for risk management tools and approaches.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

  • Understand risk management tools and when and how the tools are used in pharmaceutical, biopharmaceutical and medical device 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 development projects
  • Identify and share best practices for implementing risk-based tools and principles
  • Gain a clear understanding of the objectives outlined in ICH Guidance E6 and E8 concerning risk management in clinical trials

Who should attend?

Anyone who is needs to understand risk management working in the pharmaceutical and medical device industry, including:

  • Clinical research associates (CRAs)
  • Clinical trial managers (CTMs)
  • Quality assurance professionals
  • Regulatory affairs specialists
  • Project managers
  • Data managers
  • Those needing to understand the regulatory expectations, associated guidance and be able to apply different tools and techniques in their role.

Enrol/reserve

This course will cover:

A brief overview of risk management

  • Why risk management is important in clinical trials
  • Definitions of key risk management terminology
  • Brief overview of regulations and guidelines which cover risk management applied to the pharma and biopharma industry

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 does a regulatory inspector 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 for clinical trials including:
    • Root cause analysis
    • Risk breakdown structure
    • Risk log
    • Risk prioritisation techniques (scoring systems, heat maps, etc.)
    • Failure mode and effect analysis
    • Risk Matrix
    • Examples of pharmaceutical risk specific tools for clinical trials including Risk Assessment Categorisation Tool
  • Identification of Critical to Quality Factors
    • How to determine what is critically important to the successful completion of the trial.
  • Quality Tolerance Limits
    • What are the QTLs and how to define them
  • Applying corrective and preventative actions (CAPA)

Brief review of risk-based approaches to auditing

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Laura Brown
Independent Pharmaceutical Consultant

Dr Laura Brown is an independent pharmaceutical QA, management and training consultant and Senior Lecturer for the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has more than 20 years’ experience of quality assurance and managing international clinical trials including risk identification and management. She has worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International and is an international expert on GCP and clinical trial requirements. Laura was chair of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

4 February 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 14480

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 31 Dec

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Not ready to book yet?

for 7 days, no obligation

6 June 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 14732

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 02 May

View basket 

 
Not ready to book yet?

for 7 days, no obligation

7 October 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 14983

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 02 Sep

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

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


There were lots of useful links and information which I can use for further study of the risk management concepts and their application.

Oct 8 2024

Vladilena Daly
Operations and Compliance Manager, CliebntPharma Ltd

Oct 14 2022

Very good

Arna Hrund Arnardottir
Senior Consultant RA, DADA Consultancy BV

United Kingdom

  • Grifols UK Ltd
  • St George's University Hospital
  • Veeva

Belgium

  • Nikkiso Belgium

France

  • IPSEN

Germany

  • Boehringer Ingelheim Pharma GmbH & Co KG

Ireland

  • CliebntPharma Ltd

Netherlands

  • DADA Consultancy BV

Portugal

  • NOVA Medical School

Enrol/reserve

Run Risk Management for Clinical Research Live online for your team

1 day

Typical duration

Pricing from:

  • GBP 450
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, 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

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy