Catalent

Discover the critical steps that keep European Union and United Kingdom clinical supplies moving by understanding what a QP truly needs to prevent delays. Learn how smarter documentation, clearer communication, and proactive planning can significantly reduce risk and accelerate your trial timelines.

Delivering clinical trial supplies into the European Union and United Kingdom requires rigorous oversight from a Qualified Person (QP) to ensure every batch meets regulatory, GMP, and trial-specific requirements. Yet, many sponsors face preventable delays, often due to incomplete documentation, limited supply chain visibility, or late communication of changes. In this session, Catalent experts will break down the core responsibilities of the QP, explain how European Union and United Kingdom expectations differ, and share practical steps sponsors can take to streamline the certification process. Attendees will learn how to prepare audit-ready documentation, avoid common pitfalls that extend release timelines, and build efficient collaborations with QPs to keep studies moving without interruption.

Understand core QP duties that impact European Union and United Kingdom clinical trial timelines.

Identify common causes of release delays and how to prevent them.

Learn how to prepare documentation to streamline QP certification.

Personnel involved with: supply chain management, clinical supply/supplies, logistics, operations quality, materials management, value chain, technical operations, sourcing management, supplier management, procurement, clinical operations, packaging and labeling, vendor management, clinical trial supply, strategic sourcing, global category management (clinical services or R&D procurement), external manufacturing, CDMO management

Program managers, project managers, consultants

Senior Batch Processing Manager, Qualified Person
Catalent

, Pharmacist, is Senior Manager and Qualified Person at Catalent’s Schorndorf facility in Germany. He leads a team of Batch Processing Managers and QPs, ensuring compliance with European Union GMP and working closely with the Bathgate, Scotland, facility for United Kingdom GMP for clinical medicinal products. Hirt offers practical quality oversight, audit guidance, and supply chain visibility, supporting sponsors in regulatory requirements and efficient QP certification.


Webcasts

Webinar Date/Time: Tue, Jun 9, 2026 11:00 AM EDT

QP Essentials: Reducing Risk and Delays in EU and UK Trials

Articles

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Beyond Amorphous Solid Dispersions: Novel Applications in Pharmaceutical Spray Drying (May 2026)

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Decentralized Trials: The Value of Direct-to-Patient & Pharmacy-Led Solutions (Feb 2026)

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Integrated Clinical Development & Supply: Breaking Down the Early Development Journey of a Small Molecule

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