When: 21 - 22 October 2020 (half-days)
Where: Online
TOPRA is committed to continuing to support the education of regulatory professionals in this unprecedented situation. However, in light of recent developments and the advice from health authorities, we have made the decision for this course to go ahead as an interactive online course on the same date with many opportunities for questions to the speakers. All delegates already booked on the course will be individually contacted and if you require further information please meetings@topra.org.
Course overview
This course covers regulatory requirements for electrical, electronic, and software devices including current guidance, interpretation, and application of regulations. The practical considerations of design, development, and placement on the market for devices will be discussed. In particular, the regulation and approval of software devices is particularly challenging with limited guidance available and continual advancement of technology.
Challenges and issues concerning active devices and software devices will be explored to discuss and review solutions that are being applied by regulatory professionals. The linkage between the electrical and electronic devices and software devices will also be described, with further presentation on how other processes like risk management, usability, and product life cycle management are linking everything together. Review of key requirements will be made including comparing and contrasting electrical, electronic, and software devices between US, European Union, and other countries.
Benefits to delegates
- Meet and learn from experts in the field
- Learn by doing- participate in case studies and interactive sessions
- Build a network to support the rest of your career
- Understand all the regulations around electronic devices and software, as well as the development process and controls
CPD: This course provides 8 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download a copy of the programme here.
Presenters include
Richard Vincins, Oriel STAT A MATRIX
Suitable for
- Regulatory Affairs Professionals writing reports and dossier sections for these products
- Regulatory Affairs Professionals who wish to develop their knowledge of the regulation of electrical, electronic and software devices
- Those from allied industries who wish to have a comprehensive understanding of the subject
- Those whose companies are considering developing software that may be considered as a device.
Pricing
Simply log in or create an account and register below.
| Type |
Member |
Non-member |
| Standard |
£550+VAT |
£675+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
|
£412.5+VAT
|
£506.25+VAT |
Those working for charities, patient groups or in full-time education
|
£275+VAT |
£337.5+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
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