Course overview

This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of a variety of topics of importance to the maintenance of the commercial and regulatory health of their company's medical devices once they have been successfully placed on the market. Topics include advertising, data protection and privacy, patents and IP, health technology assessment and reimbursement, environmental legislation and standards, relationships with distributors, own-branders, authorised representatives, trade association and regulatory bodies, product supply and logistics, product liability law, unannounced audits and good regulatory practice.

Benefits to delegates

• Demonstrate the ability to critically analyse the legal, regulatory and quasi-regulatory requirements applying to medical devices
• Apply good regulatory practice particularly when interacting with regulatory bodies, including critically appraising communications
• Make recommendations about how to prepare for unannounced audits
• Deal with complex issues both systematically and creatively, make sound judgments in the absence of complete data, and communicate their conclusions clearly to specialist and non specialist audiences
• Demonstrate a critical understanding of the factors required to maximise the success of a medical device
• Understand the importance of intellectual property, data protection and product liability and judge when legal advice is required
• Demonstrate a critical understanding of health technology assessment and reimbursement
• Critically evaluate the application of environmental legislation and standards to medical devices.

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

A previous programme can be downloaded here.

Module Leader

Jane Arnold-Round
Principal Medical Research Scientist, Regulatory
NAMSA, UK 

Speakers

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.

This course is suitable for

Pricing

Standard

• TOPRA MSc students: £1,545 +VAT*
• Delegates: £1,785 +VAT*

Discounted places

A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.

• Those working for regulatory agencies, government agencies or academic institutions: £1,338.75 +VAT*
• Those working for charities, patient groups or in full-time education: £892.50 +VAT*

*VAT, if applicable, is charged at the rate of 20%.

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions.