When: 6-8 December 2023
Where: Online
Day 1 start time: 09:00 GMT
Day 3 end time: 16:15 GMT

Also available as a face-to-face course, please click here for the face-to-face registration option.

Course overview

This course is designed to provide an overview of medical devices in relation to considerations when using innovative manufacturing techniques, for example 3-D printing, and other areas of special interest, such as drug–device combinations, borderline products, ATMPs-devices and software.

Delegates will explore and critically debate the regulatory issues likely to arise from the development and manufacture of such medical devices, in order to be able to provide effective strategic and regulatory  advice to achieve successful placement of such products on the market. The module will also cover the application of legislation, directives, guidelines, interpretation and classification documents and regulatory requirements revolving around medical devices manufactured with innovative/non-traditional processes including drug-device, combination and borderline products. It will also include commentary from Notified Body and Competent Authority perspectives, special  requirements such as human factor testing and risk analysis and management of such devices. Where possible, case studies will be used to achieve those learning goals and put into practice the theory behind the relative legislation.

Very detailed overview with beneficial case studies and knowledgeable speakers.”  – 2018 delegate

Benefits to delegates

• Understand and be able to manage successfully 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. In particular, critical analysis of the further requirements related to innovative manufacturing processes
• 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.
• Demonstrate the ability to interpret, analyse and put into practice current legislation applicable to medical devices manufactured with innovative/non-traditional processes
• be able to make sound judgements of complex issues and deliver strategic solutions and conclusions that can realistically be applied in practice

Programme

You can view and download an example programme based on previous courses here

Module Leaders

• Jason Collins, Managing Director, ESPL Regulatory Consulting
• Helen Erwood, Director, Global Regulatory Affairs, ESPL Regulatory Consulting

Presenters

TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire. In addition to the module leaders listed above, previous speakers for this course include:

• Shaun Stapleton, Vice President, Regulatory Affairs and Pharmacovigilance, ReNeuron
• Greg Thay, Managing Director, Human Factors Consultant at THAY Medical
• Stuart Freeman, Toxicology Consultant, Farino Consulting
• Theresa Jeary, Technical Specialist & Scheme Manager, BSI
• Sukie Whitehall, Consultant Mechanical Engineer, Cambridge Design Partnership
• Richard Holborow, Global Head of Clinical Compliance, BSI
  
  

Suitable for

• Delegates from the regulatory affairs industry who wish to develop their knowledge of drug device combinations and other technologies
• Delegates from allied industries who wish to have a comprehensive understanding of the subject
  
  

Pricing  

Standard

• Delegate: £1,700 + VAT*
• Student: £1,500 + VAT*

Discounted places

A limited number of discounted places are available at the rates below. Please note that discounted places are not valid for those enrolled on the MSc course.

Please email us at meetings@topra.org for a discount code before making your booking.

Discount prices

• Those working for regulatory agencies, government agencies or academic institutions: £1,275 + VAT*
• Those working for charities, patient groups or in full-time education: £1,275 + VAT*

Terms and conditions

Registration

Simply log in or create an account and then register using the 'Register Myself' button that will appear below once you are logged in.