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Management Forum

Risk Management for Pharma and Biopharma Professionals Training Course

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

★★★★★ "Very good"

8 October 2024
+ 4 February 2025, 6 June 2025, 7 October 2025 »
from £549

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Format: Live online
CPD: 6 hours for your records
Certificate of completion

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Course overview

Risk management is becoming increasingly important to drug and medical device development and ensuring compliance with regulatory expectations. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, ICH GCP R2 and R3, drug and device risk based guidance during a pandemic, regulatory risk based approaches, and FDA Risk-based monitoring of Clinical Investigation questions and answers guidance.

This essential course will explain the importance of using risk management techniques in drug and device 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 development projects and demonstrate the importance of using risk analysis and risk management techniques in the pharma, biopharma and medical device industries. 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 pharma, biopharma and device development, as well as to identify and share best practices for risk management tools and approaches.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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

Who should attend?

Anyone who is needs to understand risk management working in the pharmaceutical and medical device industry. Particularly those needing to understand the regulatory expectations, associated guidance and be able to apply different tools and techniques in their role.

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This course will cover:

A brief 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 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 including:
- Root cause analysis
- Risk breakdown structure
- Risk log
- Failure mode and effect analysis
- Risk Matrix
- Examples of pharmaceutical risk tools for clinical trials included Risk Assessment Categorization Tool

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

8 October 2024

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 13937

GBP 649
EUR 929
USD 1,049

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for 7 days, no obligation

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 549 649
EUR 789 929
USD 893 1,049

Until 31 Dec

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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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 549 649
EUR 789 929
USD 893 1,049

Until 02 May

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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 549 649
EUR 789 929
USD 893 1,049

Until 02 Sep

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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.