REGU09030 2023 EU Qualified Person (QP) Certification of ATMPs

Describe the responsibilities of the QP when certifying ATMP’s

Differentiate between EU and US regulations and guidances in relation to manufacturing and testing of ATMP’s

Evaluate and describe vendor qualification requirements for  ATMP’s

For a given ATMP, determine the importation, distribution and transportation requirements for ATMP’s

Assess ATMP manufacturing and testing challenges and construct solutions

This Module will be delivered online part time.

A virtual learning environment (e.g. Moodle) will be used as a repository of educational resources and as a means of assessment. Self‑directed, student‑centred, independent learning is a core aspect through completion of module coursework. Some aspects of flipped learning, groupwork, case studies and other active learning methodologies will be incorporated into the module.

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQs, project assignments, case studies, essays, oral presentations, viva’s etc. The major element of the assessment may take the form of case studies; these will incorporate real or simulated scenarios, where groups will be tasked to propose and defend solutions.

Repeat assignments of the failed elements will be assigned as per the current Marks and Standards

1. Describe the responsibilities of the QP when certifying ATMP’s

Key considerations for the manufacture and Testing of ATMPs

• Overview of role of QP in the context of ATMPs
• Process development/validation
• Analytical method development/validation
• Importation testing
• Retain/retention samples

2. Differentiate between EU and US regulations and guidances in relation to manufacturing and testing of ATMP’s

EU GMP requirements for ATMP’s:

• Overview of EudraLex Volume 4 part IV for ATMPs
• Overview of EudraLex Volume 4 Annexes 1 and 16 and how they apply to ATMPs
• EU guidance documents for ATMP’s

US/ICH guidance documents for ATMP’s

• US guidance documents for ATMP’s
• ICH guidelines with a focus on ICH Q9, 10, and 11

3. Evaluate and describe vendor qualification requirements for  ATMP’s

Vendor Management requirements for ATMP’s

• Vendor Qualification requirements
• Supply Chain map

4. For a given ATMP, determine the importation, distribution and transportation requirements for ATMP’s

Distribution/Transportation of ATMP’s

• Import/export of ATMP’s to the EU
• Chain of custody
• Transportation Qualification
• Annex 21 requirements
• Anti-counterfeiting/falsified medicines

5. Assess ATMP manufacturing and testing challenges and construct solutions

Key considerations for QP Certification for ATMP’s

• Batch record review, QP certification and release
• MIA/MIA(IMP) updates
• QP Declarations
• Risk Assessments
• Case studies

IMP

• Parametric Release