Risk Based Monitoring and the impact of ICH-GCP E6 R3 MasterClass - US edition

15-16 April, 2025

Learn how to define, evaluate, and respond to risks, and also how to define critical data.

These two ½ days of online sessions will be very interactive with lively discussions workshops, quizzes and action planning sessions.

15-16 April, 2025, Virtual
Time Zone:Eastern Daylight Time (EDT) - UTC-04:00

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Key learnings

Implementation

Being able to provide with the rationale for Risk Based Monitoring implementation.

Describe

Describe the Risk Based Monitoring Methodology following Transcelerate

Identify

Being able to identify Critical data, processes, and Risk indicators.

Roles and Responsibilities

Describe the Risk Based Monitoring roles and responsibilities.

Barriers

Identify challenges and barriers for the Risk Based Monitoring implementation

Trusted by over 17,000 delegates across leading companies

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Overview

Risk Based Monitoring is still a hot topic despite the regulatory recommendation since 2013. This course introduces the ins and outs of risk-based monitoring in clinical trials. It will give you the rationale for implementing this approach and how to set it up within your organisation. You will learn how to define, evaluate and respond to risks, and also how to define the critical data, the risk indicators and the thresholds linked to it. Additionally, you will go through the different steps to be taken for implementing this new monitoring methodology. The roles and responsibilities of each stakeholder will be discussed as well.

These two ½ days online sessions will be very interactive with lively discussions workshops, quizzes and action planning sessions.

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Trainer

Nelle Stocquart

Solutionelle

With a masters in chemistry Nelle Stocquart works since 2003 in the Clinical Research world. She was first an IVRS project manager for a Belgian CRO but then she wished gaining more experience on the field and became CRA for a top 5 international CRO where she got involved in many international phases II & III from early study stage till closure. She then evolved as project manager in pharmaceutical companies and CRO where she managed local and international studies from phase I to phase IV. She is now working for the Belgian government which is funding academic studies. Nelle has a lot of experience in project management, team management and people coaching. Training, Coaching, Education and Continuous Professional Development have always been the common pillars in her educational path and professional
career. She speaks fluently 3 languages (Dutch, French and English).

Her real passions are technical skills trainings:

- Project Management- Risk Managment
- Risk Based Monitoring
- CRO Selection and Management
- MS Project
- Time Management
- Clinical trial budget management
- Advanced Project Management

References: GSK, Servier, Parexel, CROMSource, S-Clinica, KCE

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Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

who should attend image RECOMMENDATION

Who should attend?

Clinical Operation Managers, Data managers, statisticians, Clinical Project Managers and lead CRA who want to learn the basis of Risk-Based Monitoring in order to implement/improve it in their organisation.

Prior experience in and/or knowledge of ICH-GCP and Clinical Research is required (at least 2 years in the field).

Ticket options for you

Full event
pass

Looking for an in-house training?

*minimum of 10 participants

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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