Presented by
Management Forum
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"
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.
Anyone who is needs to understand risk management working in the pharmaceutical and medical device industry, including:
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
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
Until 31 Dec
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
Until 02 May
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
Until 02 Sep
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.
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
Belgium
France
Germany
Ireland
Netherlands
Portugal
1 day
Typical duration
Pricing from:
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: