Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies - 7FHH11xx

Regulatory Requirements for Cell, Tissue and Gene Therapies

Next course: 6 September 2021

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Students will deepen their understanding of all aspects of the regulation of advanced therapy medicinal products (ATMPs), which include cell, tissue and gene therapies.

Overview

This module examines the regulatory requirements for ATMPs in the EU and compare them with other territories, eg the US, EU, UK and Japan. It considers the scientific principles underpinning the development and regulation of ATMPs and the complexities involved.

It covers the legislation, classification and certification, and the importance of having a clear classification early in the regulatory process and borderlines between different types of ATMPs. It also includes GMP and GCP; issues specifically relating to ATMPs and other relevant legislation that must be considered, such as requirements for blood derivatives.

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Incorporate a systematic understanding and a critical awareness of the unique issues faced in the development and regulation of ATMPs to meet the EU regulatory requirements
• Demonstrate a critical understanding of the regulatory environment and legislative framework for ATMPs in other territories and how these compare with the EU
• Recognise the unique quality considerations for ATMPs and be able to design appropriate regulatory submissions to meet the quality requirements

Skills and attributes

Successful students will typically:

• Evaluate current legislation and best practice for ATMPs globally and make sound judgements in the absence of complete information
• Communicate complex regulatory requirements and quality, nonclinical and clinical considerations for ATMPs to specialist and non-specialist audiences.
• Be able to justify and recommend the best regulatory and product development plan to progress ATMPs through to marketing authorisation
• Negotiate with internal and external stakeholders, in particular quality, nonclinical and clinical development colleagues, to creatively solve regulatory and development challenges for ATMPs.

Focusing on biotech and advanced therapies? Consider:

• Module 6: Regulatory Strategy: From Development to the Market Place
• Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products
• Module 12: Data Management and Digitalisation in Regulatory Affairs
• Module 18: Drug-device Combinations and Other Technologies
• Module 20: Regulation of Electrical, Electronic and Software Devices

Expanding your options? Consider:

• Module 3: Regulatory Requirements for a New Active Substance: Quality
• Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development
• Module 10: Leadership and Strategic Management in Regulatory Affairs
• Module 11: The US Regulatory Environment
• Module 13: Principles of Medical Device Regulatory Affairs

See the table below for the next planned dates for these modules.

Module schedule

The following table outlines the scheduling for all MSc modules through 2025.

Visit our Masterclasses page to see which modules are currently open for registration.