Advanced Sponsor Oversight & Computer System Validation

This comprehensive four-day course is designed to equip clinical research professionals with the essential tools to manage and demonstrate effective Sponsor Oversight.

Count Every Second Until the Event

Date: 26-29 May 2026

0 days 00 hr 00 min 00 sc
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Course Overview

This practical and interactive masterclass provides an in-depth understanding of sponsor oversight and computer system validation within clinical research, with particular focus on sponsor responsibilities, quality management, risk-based oversight, subcontractor management, record management, data governance, and validation principles.

Across four structured sessions, the programme explores how oversight can be planned, demonstrated, and maintained in practice, while also addressing key aspects of data lifecycle management, computer systems, artificial intelligence, training, and user management. Through expert-led discussion, quizzes, and workshops, participants will strengthen their understanding of inspection-relevant oversight activities and gain practical insight into applying these principles in day-to-day clinical trial operations.

Key Topics

  • Sponsor responsibilities following ICH-GCP E6 (R3)
  • What oversight means in practice
  • Quality management
  • Quality by Design and critical-to-quality factors
  • Risk management
  • Issues and non-compliance
  • Auditing as an oversight strategy
  • Risk-based monitoring
  • Resource management, roles, responsibilities, and finance
  • Subcontractor management, agreements, documentation, and communication
  • Oversight plan content
  • Essential records management
  • Site selection and management
  • Feasibility tips and tricks
  • IMP/MD management
  • Drug accountability
  • IRT & Record management and data governance compliance
  • Data lifecycle
  • Computer systems: buy, build, configure, software-as-a-service
  • Computer system validation
  • Lifecycles
  • Artificial intelligence
  • Training and user management

Learning Outcomes

  • Understand the regulatory requirements to protect patients’ safety and ensure data integrity
  • Describe the Declaration of Helsinki principles
  • Being able to describe the ICH-GCP E6 R3 scope
  • Understand the ICH-GCP E6 R3 principles
  • Explain the roles and responsibilities described in ICH-GCP E6 R3
  • Describe the data governance requirements
  • Knowing what the essential records are

Who Should Attend?

An event precisely for you
  • Any people working in Clinical research that needs to be totally refreshed on ICH-GCP
  • Any new people in Clinical research that needs to be trained on ICH-GCP E6 R3
  • People who wanted to start a career in Clinical Research

Meet Your Trainers

Nelle Stocquart

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 & IIIN 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 Management 
  • Risk Based Monitoring
  • CRO Selection and Management 
  • Time Management 
  • Clinical trial budget management 
  • Advanced Project Management

Trev Simmons

Trev is a Data Integrity and Computer System Validation specialist with 28 years of experience within the pharmaceutical and medical device industry. He has worked on and chaired committees and working parties for industry associations, developing and delivering courses on Risk Management, Computer System Validation, and Data Integrity.

A former module adviser to the MSc in Quality Management at Cranfield University, he is currently a faculty member for audit training with the European Forum for Good Clinical Practice. Trev runs his own IT QA consultancy, offering IT/CSV auditing and Quality Assurance / Quality Management advice.

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