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Risk Management in Clinical Trials

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Remote Course Face-to-face Course

Course Information

Immerse yourself in the realm of clinical trial risk management with our comprehensive training programme, designed as an ideal pathway into this field. Tailored for individuals familiar with ICH Guidelines for Good Clinical Practice (ICH GCP E6(R2)) and ICH Guideline on General Considerations for Clinical Studies (ICH E8(R1)), this course pivots towards applying risk management principles to clinical trials. It's equally beneficial for professionals with quality or risk management experience from diverse disciplines. Prior experience in clinical trials and familiarity with the ICH Guidelines is recommended. 

Practical Emphasis:

Our course focuses intensively on the practical aspects of clinical trial risk management. Engage in workshops designed to provide firsthand experience in deploying risk management techniques within a clinical trial context. Guiding you through this journey are seasoned quality professionals, imparting theoretical knowledge through their rich practical experiences.

Key Learning Outcomes:

By the course's conclusion, delegates will:

  • Gain a crystal-clear understanding of the objectives outlined in ICH Guidance E6 and E8 concerning risk management in clinical trials
  • Uncover potential pitfalls in clinical trials and learn how robust risk management strategies can prevent serious compliance issues
  • Understand the roles and responsibilities pertinent to risk management in the context of clinical trials
  • Explore a range of techniques to identify and mitigate risks in clinical trials, reinforced with practical examples and supportive documents
  • Expand your professional network, fostering opportunities for career advancement in auditing.

Benefits:

You will acquire:

  • A thorough comprehension of the quality professional's role in facilitating clinical trial risk management activities
  • Enhanced compliance with Good Clinical Practice standards by proactively identifying and mitigating risks before they escalate into serious compliance issues.

Interactive Structure:

Structured to foster active participation, delegates are encouraged to:

  • Engage in vibrant discussions, idea development, and problem-solving
  • Examine critical aspects of risk management within the context of clinical trials

This course is tailored for:

  • QA Auditors tasked with reviewing risk management processes during audits, seeking a deeper understanding of the process
  • Quality professionals involved in risk management processes
  • Project Managers aiming to better grasp the identification of compliance risks within clinical trials

Tutors

Tutors will be comprised of (click the photos for biographies):

Rosemarie Corrigan

Rosemarie Corrigan

EVP Global Quality, Worldwide Clinical Trials

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Rosemarie Corrigan

Rosemarie is an experienced global leader in Quality, Audit, Compliance, and Quality Risk Management and provides consultancy services to pharma and Biotech. Previously she held the position of EVP Global Quality at Worldwide Clinical trials where she directed and oversaw quality and compliance programs for all areas of the Worldwide organization encompassing QMS, quality risk management, audit, training, standards and controlled documents, data integrity, audit and inspection readiness, process improvement, and quality metrics. Previously Rosemarie was the Chief Quality Officer at Nordic Nanovector, where she established the QA strategy and operations for development of radiopharmaceutical products.

Rosemarie holds a Masters in Bioethics and Medical Law from St Mary's University, London, and a Batchelor of Science in Biochemistry from University College Galway. She is eligible to be an QP for IMPs. She is a Fellow of Research Quality Assurance and Fellow of Royal Society of Biology. She is the current chair of RQA GCP committee.

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Cathy Dove

Cathy Dove

Director and Owner, Dove Quality Solutions

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Cathy Dove

Cathy Dove is a Quality & Risk Management Industry expert, providing risk and quality management consultancy along with GCP audits and bespoke training to a range of Pharma and Biotech clients. She is an RQA GCP Committee member and member of the EFGCP Quality Working Group, working within Clinical Quality Compliance and Risk Management.

Cathy has over 30 years Global Pharmaceutical Clinical Research expertise (Phase I-IV) both from Pharma and CRO and is also a pharmacist. During her career, Cathy has held various global senior leadership positions (including 2 years based in Singapore). Her responsibilities included project quality management, internal audits across all Clinical Research Services, preparation, hosting, and follow-up of inspections from all major regulatory inspectorates and sponsor audits.

As an independent consultant Cathy continues to support clients with inspection readiness, risk and quality management projects, sponsor oversight and vendor audits, complex system and for cause site audits and bespoke training courses.

Cathy has been a course tutor for the RQA GCP Auditing Course for over 20 years and is the course principle for the Risk Management in Clinical Trials course.

Patricia Henley

Patricia Henley

Associate Director, GD Quality Management (GCP), Regeneron Pharmaceuticals Inc

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Patricia Henley

Patricia has over 20 years of experience in clinical research within a variety of roles. Patricia is a Fellow of the Research Quality Association, where she is an active member of the GCP Committee.

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Programme

Please note timings may be subject to alteration.

Day 1

09:00

Welcome and Objectives

09:35

Risk Management Regulatory Framework

Introduction to the clinical trial risk management process. The concepts of risk management. A brief review of the regulations and guidelines that describe risk management requirements in clinical trials.

10:30

Break

10:50

Introduction to the CRASH 2 Trial

CRASH 2 was a non-commercial trial to investigate the effects of antifibrinolytic treatment on death and transfusion requirement in trauma patients.

11:30

Identification of Critical to Quality Factors

How to determine what is critically important to the successful completion of the trial.

12:00

Lunch

13:00

Workshop 1 - Identifying the Critical to Quality Factors for CRASH 2

13:45

Pragmatic Approach to Risk in the Non-commercial Environment

Identification and management of clinical trial risk with limited staff and resources.

14:45

Risk Identification in the Commercial Environment

How to manage risk in a large, siloed environment making best use of the available data sources.

15:45

Break

16:00

Workshop 2 - CRASH 2 Risk Assessment

17:15

End of day Q&A

17:30

Close of Day

Day 2

09:00

Q&A from Day 1

09:15

Quality Tolerance Limits

What are the QTLs and how to define them.

10:00

Workshop 3 - Identifying QTLs for CRASH 2

11:00

Break

11:15

Risk Based Audit Programs

How to develop more effective audit programs focusing on the areas of highest risk to the conduct of clinical trials.

12:30

Lunch

13:30

Hidden Trial Risks

Areas of risk that are often under-estimated in clinical trials.

14:30

Auditing Risk Based Monitoring Trials

How to adapt your site auditing techniques for RBM trials and determining the acceptability of clinical trial data.

15:30

Break

15:45

Workshop 4 - Auditing a Site with Risk Based Monitoring

16:25

Final Q&A

16:45

Close of Course

Extra Information

Course material

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.

Please note this course will run in UK timezone.

The advantages of this include:

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course Access to an online course group to enhance networking


You will need a stable internet connection, a microphone and a webcam.

Development Level

Develop

  • The course was conducted in a very much professional way in terms of sharing the material and relevant information well in advance, punctuality, well managed sessions and the contents. The trainers' experience was visible and the participants also had some very relevant queries and thoughts. The workshops conducted in groups in a remote workshop is something commendable - the switching over to separate meeting rooms was seamless and quick. While I understand the limitation of the time available.

  • Obviously a very experienced and knowledgeable speaker. Provides a jam packed presentation style that provides a significant amount of information providing background to the slide text.

  • Very interesting training with good presentations and interactions.

Book now

Click below for Course dates/fees:

Remote Course Face-to-face Course
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