Foundations of a Compliant EU–UK GMP–GDP Supply Chain: From Importation to Distribution
Discover how to establish a compliant and efficient EU–UK GMP–GDP supply chain
Date: June 2, 2026
Time: 10:00-11:00 AM US EDT / 4:00-5:00 PM CEST
About the Webinar
Establishing a compliant and efficient EU–UK GMP–GDP supply chain requires more than regulatory awareness — it demands a clear understanding of roles, responsibilities, and operational integration across importation, certification, and distribution activities. As organizations expand into European and UK markets, navigating the distinctions between Marketing Authorization Holders (MAH) and Manufacturing/Importation Authorization Holders (MIAH), as well as managing Qualified Person (QP) responsibilities and import testing requirements, becomes critical to ensuring timely and compliant product release.
In this webinar, we will explore the key components of building and maintaining an operational EU GMP–GDP supply chain, from initial importation through to final distribution. We will examine, QP certification and licence requirements, alongside the transition from GMP-controlled activities to GDP-compliant distribution. The session will also cover the role of the Responsible Person (RP), and the financial and physical flow considerations within supply chain models depending on distribution models.
Additionally, we will highlight the unique regulatory nuances of the UK market, including importation pathways from the EU/EEA and third countries, and the roles of the QP, RP, and Responsible Person for Import (RPi).
Through practical insights and real-world experience, this webinar will demonstrate how an integrated approach to regulatory compliance, licensing, and supply chain design can help organizations avoid delays, ensure inspection readiness, and deliver medicinal products to patients efficiently and in full compliance with EU and UK requirements.
Unable to join? Register and you will receive the recording after the live session.
Meet the Speakers
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Ruth Buchanan
Associate Director, Quality & Compliance
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Marie Warren
Senior Compliance & Quality Assurance Consultant
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Raphael Richarz
Senior Compliance & Quality Assurance Consultant
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Marwa Al-Fakhri
Associate Director, Compliance and Quality Assurance
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Ruth Buchanan
Miss Ruth Buchanan has a BSc in Applied Chemistry and is a member of the RSC. She has over 29 years’ experience working within the pharmaceutical industry across the product life cycle with both branded and generic small companies and multi-nationals and in consultancy with area of expertise in compliance and quality including product development, process and equipment validation, facilities projects, product launch, manufacturing, Qualified Person batch release, storage and distribution, end user complaint investigation, manufacturing and packaging deviation investigation, CAPA implementation and sometimes assessing whether batch recall is required from the market place. She has experience of vendor audits covering laboratories, excipients, API’s, primary and secondary packaging, warehouses and finished dosage form manufacturers and regulatory inspections undertaken by various agencies including the MHRA, US FDA, Korean MFDS and Turkish Ministry of Health.
She was assessed eligible to be named as a Qualified Person under the permanent provisions in 2007 [MHRA Ref: 1275831]
Marie Warren
Mrs Marie Warren has a BSc in Biology and is a Member of the Royal Society of Biology. She has over 20 years’ experience working within the pharmaceutical industry across the product life cycle from API to finished product manufacturer, testing, packaging and release. With roles in both branded multi-nationals and in small scale CMO and Contract Laboratory and consultancy businesses, Marie has extensive experience working with both sterile dosage forms and orals solid dose in Quality and Technical Expert roles. She has expertise in compliance and quality including process and equipment validation (including validation of sterilisation cycles); manufacturing; inspection and packaging; Qualified Person batch release of finished product, API and intermediate material; storage and distribution; complaint investigation; manufacturing and packaging deviation investigation; CAPA implementation and effectiveness checks. She has been actively involved investigation and decision making where product recall has been required in conjunction with multi disciplined teams and has managed Operational Quality, Technical and QC teams, taking responsibility for effectiveness of those functions and the QMS. She has experience of hosting and presenting data in regulatory inspections undertaken by various agencies including the MHRA, Ministry of Health for Russian Federation, US FDA, ANVISA and others and has undertaken audits of third party suppliers, contract manufacturers and Laboratories.
She was assessed eligible to be named as a Qualified Person under the permanent provisions in 2016 [MHRA Ref: 15814818].
Raphael Richarz
Dr. Raphael Richarz holds a doctoral degree in Chemistry and brings more than nine years of experience as a Qualified Person (QP) in the pharmaceutical industry, alongside over thirteen years of involvement in GMP/GDP‑focused quality management. He has held senior roles in both production and quality control within commercial GMP manufacturing and serves as an active global GMP/GDP auditor with ProPharma.
As a project manager, Raphael leads clients through a wide range of quality assurance initiatives, including the development and implementation of Quality Management Systems, technology transfers, gap assessments, inspection readiness, and ongoing quality system support. He routinely acts in key roles such as QA, QP, RP (GDP), and ad‑hoc consultant. Raphael has successfully supported multiple clients in obtaining Manufacturing and Import Authorisations (MIA) and Wholesale Distribution Authorisations (WDA) from various health authorities. Raphael possesses extensive expertise in current GMP requirements, including EudraLex Volume 4 and 21 CFR 210/211, with broad experience across production, quality control, and regulatory compliance for both human and veterinary medicinal products. His competencies include Quality Assurance and Risk Management, QMS development, import and QP release, supply chain oversight, technical assessments, and regulatory consulting.