Risk Based Monitoring MasterClass - EU edition

17-18 September, 2024

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

Risk Based Monitoring MasterClass - EU edition

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

17-18 September, 2024, Virtual
Time Zone: UTC/GMT+1 /CET

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Online MasterClass Overview Image

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.

#masterclass     #glceurope      #pharmaonlinetraining      #globalleadingconferences       #riskbasedmonitoring        #clinicaltrials

Trainer
Nelle Stocquart
Nelle Stocquart
Solutionelle
With a master’s 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

She is also able to provide training on:
- Introduction to Clinical Trials
- From study drug discovery until market authorisation (basic)
- GCP trainings
- CTR536/2014
- Belgian Law 2004 and 2017
- Netherlands Legislation
- Etc.

She is providing standardized training but also tailor-made sessions adapted to the specific needs of the client and the company.

Languages: French & English.

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

who should attend imageRECOMMENDATION

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).

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 it’s 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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21,521

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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

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