When: 5 -7 July 2022
Times: Day 1 start time: 10:15 BST (GMT+1) | Day 3 end time: 16:15 BST (GMT+1)
Location: Hunton Park Hotel, Essex Ln, Watford, Kings Langley WD4 8PN
Also available as an virtual course, please click here for the virtual course registration option.
Course overview
With a growing trend in the crossover between pharmaceutical and medical device regulatory affairs, it is becoming increasingly important for pharmaceutical regulatory professionals to be aware of the issues surrounding medical device regulatory affairs.
Put together by practicing medical device regulatory affairs professionals, this newly researched and updated course is demanded by regulatory affairs managers who wish to get their people up to speed on current European medical device regulatory practices.
You will return to your office a more confident and proactive medical device regulatory affairs professional who will be able to understand and comply with the medical device regulations, classify medical devices, assess borderlines issues and establish and maintain an internal audit programme and a supplier audit programme.
The course will also enable you to prepare and manage a third party audit, recognise diverse country requirements, advise on how to conduct a clinical investigation and implement a copy approval process.
This week was massively useful. It helped to fill the gaps in my beginner knowledge in Regulatory Affairs. The course was very organised, with a great range of speakers and access to course notes.” – 2018 delegate
Benefits to delegates
Delegates will learn the:
- role of the essential requirements / harmonised standards and how to demonstrate conformity.
- different conformity assessment routes and how to select the most appropriate route for their product
- role of risk management in pre and post market phase and be able to advise on a risk management policy and procedure.
- need for clinical evidence for CE marking
- needs of payers and how to include these as part of the development of the device regulatory package.
- key elements within a PMS system
- criteria for vigilance and the Competent Authority (CA) expectations
- minimum requirements and CA expectations for implementing an FSCA.
- impact of marketing literature on regulatory status
CPD: This course provides 23 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Accommodation
Preferential rates for delegates are available at the Hunton Park Hotel. Please e-mail meetings@topra.org after booking the course for information on how to access it.
Programme
Download a copy of the course programme here.
Presenters
Howard Dobbs, Howard Dobbs Consulting Ltd
Jonathan Hughes, JHRA Ltd
Peter Bowness, MCRA
Rachel Hattersley-Dykes, Devdone
Steve Lee, ABHI
Theresa Jeary, BSI
Suitable for
- Those with 1-2 years experience in Medical Devices
- Those who want a broader understanding of Medical Devices
- Anyone who works in other areas of Regulatory Affairs who is looking to move into, has an interest in or would like further understanding of Medical Devices
- Anyone in medicines regulation who works with Drug Device Combination Products
Pricing
Standard
- Member: £1500+VAT*
- Non-member: £1700+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: £1,125+VAT
- Those working for charities, patient groups or in full-time education: £1,275+VAT
*VAT, if applicable, is charged at the rate of 20%.
Terms and conditions
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.