Advanced Good Clinical Practice & GCP Inspection Updates

Staying ahead in clinical research: Enhancing compliance & performance through advanced good clinical practice (GCP) & GCP inspection updates
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Course Overview

This practical course provides an in-depth understanding of latest GCP requirements and its practical implications as well as the insights into the current GCP inspection focus and hot topics. The course will bring clarifications on risk-based approaches used in clinical trials, including quality tolerance limits, and how to achieve appropriate risk based monitoring and central monitoring. You will discuss what good sponsor oversight looks like and how to achive it.

You will also learn about regulatory inspection results and Data integrity challenges and how
to achieve inspection readiness.

Key Topics

We, at Wehive, offer you in-house training programmes conducted by inspiring coaches that are
Major developments in GCP and practical implications
Clinical Trial risk-based approach - implementation & best practices
GCP inspections: Outcomes and practices (MHRA/EMA/FDA)
ICH E6 R3 changes
Sponsor oversight
Data integrity in clinical trials

Learning Outcomes

  • Understand practical implementations of major developments in GCP including ICH E6 (R2), ICH E6 (R3), ICH E8 (R1), European Clinical Trial Regulation
  • Discuss risk assessment tools and best practices
  • Hear about GCP inspection outcomes and practices (MHRA/EMA/FDA)
  • Familiarize yourself with Clinical Trial Risk Management
  • Get critical insides regarding Sponsor oversight
  • Explore GCP inspection readiness

Who Should Attend?

An event precisely for you
  • Clinical Quality Assurance
  • Clinical Operations
  • Clinical Project Management
  • Clinical Quality Project Management
  • Clinical Auditing
  • Medical Quality
  • Development Quality
  • Medical Compliance
  • R&D QA
  • Clinical CAPA
  • GCP Compliance
  • Clinical Process Management
  • Clinical Data Quality
  • Clinical Quality Oversight

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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