When: 2–4 November 2022
Where: Online
Start time Day 1: 13:30 GMT | End time Day 3: 15:45 GMT
Also available as a face to face course, please click here for the face to face registration option
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.
CPD: This course provides 19 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
A copy of the draft agenda 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. Confirmed speakers for this course:
This course is suitable for
Delegates from the regulatory affairs industry who wish to develop their knowledge of the regulatory and related activities through the lifecycle
Delegates from allied industries who wish to have a comprehensive understanding of the subject
Pricing
Course fees:
| Type |
Student |
Delegate |
| Standard |
£1500+VAT |
£1700+VAT |
* VAT, if applicable, is charged at 20%
Discounted places
A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities, patient groups or full time education at £1275+VAT
Please email us at meetings@topra.org for a discount code before making your booking.
Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer.
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Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions