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Risk Based Quality Management in Clinical Trials

Understand risk management principles and the links between study level risk management and the implementation of risk based monitoring

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30 - 31 Oct 2025

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On location

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English

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13,500 DKK ex VAT

(app. 1,815 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS
Home > Courses > Risk Based Quality Management in Clinical Trials

Summary

In this two day course you will get the basic tools to apply a risk-based approach when managing your clinical trial. We will review the principles of risk management and how to apply them within a clinical trial setting according to ICH GCP.

You will also get the opportunity to practice the necessary skills when we look at examples from actual inspections and discuss how to apply a risk-based approach on areas where change is needed.

Along with identification and evaluation of risks in critical processes, study data and clinical trial operations, it is imperative to ensure that the necessary processes are in place. This course will allow you to appraise your current processes, people and technology with a view to improve oversight and enhance patient protection while maintaining high quality data.

We aim to provide a balance between trainer input, exercises and participant interaction.


Other course participants say

“Good allround training in trial risk management.” 

Anne Sager, Clinical Trial Manager


“I learned a lot about risk assessment at the course. I liked the way the participants were activated both in the lecture-based sessions and in group work.” 

Janni Brødbæk, Functional leader, OPEN


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    Course leader & lecturers

    • Rikke Jantzen
      Course leader
      Principal Risk Based Quality Management Specialist
      Novo Nordisk A/S
    • Sue Gregory
      Course leader
      Director, GCP QA
      KLIFO A/S
    • Alicja Budek Mark
      Lecturer
      Associate Director, Team Lead, RBQM
      Genmab A/S
    See all

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    Is this course for you?

    This course is designed to benefit experienced clinical research professionals who are embarking on implementation of a risk-based approach to clinical trials. Employees working in pharmaceutical and biotechnology companies, CROs and health care sites conducting commercially sponsored studies will benefit from the course.

    What you will learn

    1. How to review the basic principles of risk management and utilize them to take a ‘risk-based approach’
    2. How authorities interpret the ICH GCP through review of inspection/audit findings
    3. How to document, prioritize risks and plan mitigation activities and their measurements
    4. How to develop descriptive metrics for your risks
    5. How to identify acceptance criteria and actions
    6. How to review and document your approach
    7. How to discuss methods to communicate and report the approach taken and share best practice

    What your company will get

    1. A clinical research professional who understands the principles of risk management and application in a clinical research setting
    2. An employee who will be able to utilize a risk-based approach and define measurable metrics to report on the actual progress for all stages of the clinical trial process from study design, study conduct to study reporting
    3. A professional who can identify and evaluate risks to critical study processes and data and employ mitigation and corrective and preventive action where indicated
    4. A professional who can provide valuable input towards implementation of a risk-based approach across all disciplines within a clinical research unit

    Course calendar

    Starting 30 Oct 2025
    30 Oct 2025 9:00-16:00
    Day 1
    • Welcome and setting the scene
    • Clinical process and data identification + exercise 1
    • Risk identification and evaluation + exercise 2
    • Risk control + exercise 3
    • Preparation for day 2
    • End of day 1
    31 Oct 2025 9:00-16:00
    Day 2
    • Recap on day 1
    • Risk review + exercise 4
    • Risk communication and risk reporting + exercise 5
    • Consolidation + exercise 6
    • Kahoot and wrap up
    • End of day 2
    Practical information

    Registration

    Registration deadline
    16 Oct 2025
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    30 - 31 Oct
    Sometimes things change. This is the expected programme.

    Course information

    Literature

    Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

    Please familiarize yourself with the mandatory readings before starting the course.

    Examination

    There is no examination for this course.

    Course leaders

    Rikke Jantzen
    Principal Risk Based Quality Management Specialist
    Novo Nordisk A/S
    Sue Gregory
    Director, GCP QA
    KLIFO A/S

    Lecturer

    Alicja Budek Mark
    Associate Director, Team Lead, RBQM
    Genmab A/S

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    Want to know more or need help?

    Contact Client Manager Christina Spangsberg at +45 39 15 09 22

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