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REGU09029 2023 ATMP Quality Systems and Regulatory Affairs

General Details

Full Title
ATMP Quality Systems and Regulatory Affairs
Transcript Title
ATMP Qual Syst and Reg Affairs
Code
REGU09029
Attendance
N/A %
Subject Area
REGU - 0421 Regulatory Affairs
Department
LIFE - Life Sciences
Level
09 - Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2023 - Full Academic Year 2023-24
End Term
9999 - The End of Time
Author(s)
Ailish Breen
Programme Membership
SG_SATMP_S09 202300 Postgraduate Certificate in Advanced Therapy Medicinal Products (ATMP) Vector Manufacturing SG_SATMP_O09 202300 Postgraduate Diploma in Science in Advanced Therapy Medicinal Products (ATMP) Technology and Manufacturing SG_SATMP_M09 202300 Master of Science in Advanced Therapy Medicinal Products (ATMP) Technology and Manufacturing SG_SATMQ_M09 202300 Master of Science in Advanced Therapy Medicinal Products (ATMP) Vector Manufacturing
Description

This module is taken by Level 9 students enrolled on the MSc. in ATMP Manufacturing.

It aims to provide students with the background of Advanced Therapy Medicinal Products (ATMP) and how they differ to traditional biopharmaceuticals. In addition, the students will get an overview of the EU and US regulations that apply to ATMPs.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Discuss the nature and production of ATMP products

2.

Describe ATMP manufacturing challenges, current and developing technologies, and quality control / quality affairs

3.

Evaluate the global regulatory framework for biotechnology derived products

4.

Differentiate the applications of EU & US regulations for ATMP marketing authorisations

5.

Critically analyse EudraLex Volume 4 part IV and Annex I

Teaching and Learning Strategies

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.

Module Assessment Strategies

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: project assignments, evidence based assignment / critiques /essays, case studies, oral presentations, viva’s etc.

Repeat Assessments

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

Indicative Syllabus

Discuss the nature and production of ATMP products

  • What are ATMPs in EU and US and Types of ATMPs (cell therapy, gene therapy, regenerative medicine)
  • History of ATMP development
  • Drug development and clinical trials
  • Roles and responsibilities

Describe ATMP manufacturing challenges, current and developing technologies, and quality control / quality affairs.

  • Key considerations for the manufacture and testing of ATMPs
  • Product lifecycle and product approval pathway in the EU and US

Demonstrate an understanding of the global regulatory framework for biotechnology derived products

  • EU guidance documents (EudraLex)
  • US ATMP guidance documents (FDA website)
  • ICH guidelines with a focus on ICH Q8, Q9, Q10, and Q11.

Differentiate the applications of EU & US regulations for ATMP marketing authorisations

  • Expedited Regulatory pathways for ATMPs in the EU and US
  • Accelerated pathways and orphan drug designation

Critically analyse EudraLex Volume 4 part IV and Annex I

  • Overview of EudraLex Volume 4 Annex I and how it applies to ATMP
  • Overview of EudraLex Volume 4 part IV for ATMPs

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Assignment Coursework Assessment Assignment 20 % Week 4 1,2
2 Case study Coursework Assessment Assignment 30 % Week 11 3
3 Project and presentation Coursework Assessment Individual Project 50 % End of Semester 4,5

Online Learning Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Online Lecture 2 Weekly 2.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2015-09-25 Regulatory Aspects of Gene Therapy and Cell Therapy Products Springer
ISBN 3319186175 ISBN-13 9783319186177

This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.

Recommended Reading
2020-06-27 A Handbook of Gene and Cell Therapy Springer Nature
ISBN 9783030413330 ISBN-13 3030413330

This is a reference handbook for young researchers exploring gene and cell therapy. Gene therapy could be defined as a set of strategies modifying gene expression or correcting mutant/defective genes through the administration of DNA (or RNA) to cells, in order to treat disease. Important advances like the discovery of RNA interference, the completion of the Human Genome project or the development of induced pluripotent stem cells (iPSc) and the basics of gene therapy are covered. This is a great book for students, teachers, biomedical researchers delving into gene/cell therapy or researchers borrowing skills from this scientific field.

Module Resources

Non ISBN Literary Resources
Updated Literary Resources
Journal Resources
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Additional Information