Sponsor Oversight MasterClass

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

This practical course provides an in-depth understanding of latest GCP requirements 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
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Defining “sponsor oversight” according to current (R2) and future (R3) ICH E6 requirements
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Learning about the guiding principles for Sponsor Oversight
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Becoming aware of the challenges
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Discussing current inspection outcomes regarding Sponsor Oversight
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Improving the collaboration between sponsors and service providers
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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 third party selection principles

Who Should Attend?

An event precisely for you
  • Clinical Operations
  • Clinical Project Management
  • Clinical Quality Assurance
  • Clinical Quality Project Management
  • Clinical Quality Oversight
  • GCP Compliance
  • Clinical Process Management

Meet Your Trainer

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 travelling, cycling, swimming and painting, and hopes to be able to see a few more deserts in the world.

Jeannette Dixon

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