Module 18: Drug-device Combinations and Other Technologies - 7FHH1156

Drug-device Combinations and Other Technologies

Next course: January/February 2023

Students will consider and evaluate the practical quality and regulatory aspects of drug-device combinations and medical devices manufactured by innovative manufacturing techniques.

Overview

To explore and critically debate the quality and regulatory issues likely to arise from the manufacturing of medical devices with such techniques, in order to provide effective management and advice about placing combination products on the market.

This module is for regulatory professionals interested in or working with medical devices manufactured with innovative/non-traditional processes and/or falling within the classification of drug-device, combination and/or borderline products. It covers the application of legislation, directives, guidelines; interpretation and classification of documents and regulatory requirements revolving around medical devices manufactured with innovative/non-traditional processes, including drug-device combination and borderline products. It also looks at PMS, vigilance, notified body/competent authority, special requirements for clinical evaluation and testing, risk analysis and management.

The lectures cover a diverse scope but stayed true to the drug device topic."

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Successfully manage the application of regulatory requirements and relevant legislation, including required documentation, for the purpose of placing medical devices and drug-device combination products on the market
• Critically analyse the further requirements related to innovative manufacturing processes and recommend strategies for development and marketing of medical devices manufactured with innovative/ non-traditional processes
• Demonstrate critical understanding of issues related to requirements dictated by applicable legislation over and above the medical device regulations
• Judge appropriate regulatory strategies for drug-device combination and borderline products.

Skills and attributes

Successful students will typically:

• Demonstrate the ability to interpret, analyse and put into practice current legislation applicable to MDs manufactured with innovative/non-traditional processes
• Make sound judgements of complex issues and deliver strategic solutions and conclusions that can realistically be applied in practice
• Critically appraise and evaluate communications from regulatory bodies and research publications regarding medical devices manufactured with innovative/non-traditional processes.

Developing expertise in cutting edge medical technologies? Consider:

• Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies
• Module 20: Regulation of Electrical, Electronic and Software Devices      
• Module 12: Data Management and Digitalisation in Regulatory Affairs

Expanding your options? Consider:

• Module 14: Design, Development and Certification of Medical Devices
• Module 15: Clinical Evaluation of Medical Devices
• Module 16: Post-Market Surveillance and Vigilance for Medical Devices
• Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products
• Module 21: US Regulation of Medical 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.