Sponsor Oversight MasterClass

This practical course provides an in-depth understanding of latest GCP requirements (ICH E6 R3) regarding Sponsor Oversight and its practical implications as well as insights into current GCP inspection observations relating to Sponsor Oversight.

Count Every Second Until the Event

Date: 08 September 2025

0 days 00 hr 00 min 00 sc
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Course Overview

This practical course provides an in-depth understanding of latest GCP requirements (ICH E6 R3) regarding Sponsor Oversight and its practical implications as well as insights into current GCP inspection observations relating to Sponsor Oversight. The course will also bring clarifications on the guiding principles for Sponsor Oversight and how to achieve improved collaboration between sponsors and service providers.  This course will provide sufficient opportunities to discuss best working practices with other participants representing clinical research sponsor teams.

Key Topics

We, at Wehive, offer you in-house training programmes conducted by inspiring coaches that are
Defining “sponsor oversight” according to ICH E6 (R3) requirements
Learning about the guiding principles for Sponsor Oversight
Becoming aware of the challenges
Discussing current inspection outcomes regarding Sponsor Oversight
Improving the collaboration between sponsors and service providers
Workshops

Learning Outcomes

  • Taking away the guiding principles for Sponsor Oversight
  • Having full awareness of the potential inspection risks
  • Developing best practices and implementation of Sponsor oversight
  • Gaining awareness of service provider selection principles

Who Should Attend

  • Clinical Operations
  • Clinical Project Management
  • Clinical Quality Assurance
  • Clinical Quality Project Management
  • GCP Compliance
  • Clinical Process Management
  • Clinical Quality Oversight

Meet Your Trainer

Jeannette Dixon

Jeannette has held GCP quality-focused positions since 2008 at various pharmaceutical companies, and started her own consultancy business in 2017, including employment as Director R&D QA at A Gene Therapy biotech company. Prior to transitioning to GCP/GCLP work, she held positions in pharmaceutical training management, project management in Phase I-IV projects, worked as CRA and in academic research laboratories. Jeannette led quality teams and has extensive experience in Quality Management System (QMS) development, managing audits, CAPAs, risk management and inspection readiness activities as well as in hosting several regulatory agency inspections.

Her educational background is a BSc in Medical Sciences, a BSc in Pharmacology, and a Master in Quality Management. She enjoys traveling, cycling, swimming, and painting, and hopes to be able to see a few more deserts in the world

Request to Assign a Team Member!

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