This module 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.
When: 24-26 October 2016
Where: TOPRA, 6th floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Start time (Day 1): 13.00
End time (Day 3): 15.45
Who is it for?
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This course is suitable for anyone working in medical devices or individuals involved or interested in this area and students completing their MSc in regulatory affairs.
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What will I learn?
Knowledge and understanding:
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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.
Skills and attributes:
- Demonstrate the ability to critically analyse the legal, regulatory and quasi-regulatory requirements applying to medical devices
- 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
- Apply good regulatory practice particularly when interacting with regulatory bodies, including critically appraising communications
- Make recommendations about how to prepare for unannounced audits.
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Programme
Download the course programme
Presenters
Benefits
Successful completion of this course counts as 21 hours of Continuing Professional Development (CPD).
To learn about why CPD is important visit our Lifelong Learning page.
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How do I apply?
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Course fees:
| Type |
Student |
Non-Student |
| Standard |
£1500+VAT |
£1700+VAT |
Discounted places
A limited number of discounted places are available for those working in regulatory agencies, government bodies, charities or patient groups . Please email us for a discount code before making your booking.
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Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.
Travel and accommodation are not included.
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