Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products - 7FHH1147

Registration of Biological, Biotechnology and Advanced Therapy Products

Next course: March/April 2023

Students will evaluate practical aspects of regulatory strategy for biological, biotechnology and advanced therapy products; and explore the regulatory issues likely to arise with these products so they can provide effective advice to avert or resolve such issues.

Overview

This module enables students to have a thorough understanding of the scientific principles underpinning the development of biological/biotechnology products and how their inherent complexities impact on regulation. It also considers the data requirements for such products and allows students to examine the regulatory requirements imposed on biological, biotechnology and advanced therapy products.

The overall training was awesome. I gathered a lot of knowledge in biologicals."

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Display a critical awareness of the unique nature of this topic area and strategies for development of biological, biotechnology and advanced therapy products
• Possess a comprehensive understanding of the regulatory requirements and documentation associated with the licensing of biological, biotechnology and advanced therapy products
• Demonstrate a conceptual understanding of the legal and pharmaceutical requirements that define the regulatory strategy for biological, biotechnology and advanced therapy products.

Skills and attributes

Successful students will typically:

• Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding biological, biotechnology and advanced therapy products
• Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of biological, biotechnology and advanced therapy products
• Critically appraise and evaluate communications from regulatory bodies and research publications regarding biological, biotechnology and advanced therapy products.

Focusing on biotech and advanced therapies? Consider:

• Module 1: Strategic Planning in Regulatory Affairs
• Module 2: Regulatory Strategy for a New Active Substance: Nonclinical Development 
• Module 12: Data Management and Digitalisation in Regulatory Affairs

Expanding your options? Consider:

• Module 6: Regulatory Strategy: From Development to the Market Place
• Module 11: The US Regulatory Environment
• Module 13: Principles of Medical Device Regulatory Affairs
• Module 18: Drug-device Combinations and Other Technologies
• Module 20: Regulation of Electrical, Electronic and Software Devices

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.