When: 13-15 June 2018
Where: De Vere Latimer Estate, Chesham, Buckinghamshire, HP5 1UG, United Kingdom
ONLINE BOOKING HAS NOW CLOSED - IF YOU WOULD LIKE TO REGISTER, PLEASE EMAIL MEETINGS@TOPRA.ORG
What is it
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 practising 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.
After three days you will return to your office a more confident and proactive medical device regulatory affairs professional who will be able to determine which directives apply to which products, 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.
What will I learn
Download the course programme
- The role of the essential requirements / harmonised standards and how to demonstrate conformity.
- The different conformity assessment routes and how to select the most appropriate route for their product
- The role of risk management in pre and post market phase and be able to advise on a risk management policy and procedure.
- The need for clinical evidence for CE marking
- The needs of payers and how to include these as part of the development of the device regulatory package.
- The key elements within a PMS system
- The criteria for vigilance and the Competent Authority (CA) expectations
- The minimum requirements and CA expectations for implementing an FSCA.
- The impact of marketing literature on regulatory status
- The unique requirements of the IVD Directive
Why should you attend
- 3 interactive days with a comprehensive range of topics and case studies
- Networking opportunities with peers and industry professionals
- An international speaker panel from agency and industry
- High-quality course materials
- All inclusive meals
More on TOPRA introductory courses
What is included
- Three interactive days with a comprehensive range of topics and case studies
- Over 8 hours of networking opportunities.
This course offers 23 CPD hours for successful completion, to learn about why CPD is important visit the Lifelong Learning page.
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.
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|A limited number of discounted places are available at the rates below. Please email us for a discount code before making your booking.
Those working for regulatory agencies, government agencies or academic institutions
| Non Member
|Those working for charities, patient groups or are in full-time education
Please contact the TOPRA office
- Please note the registration fee excludes accommodation.
- Refreshment breaks, lunch for three days and two evening meals are included in the registration fee.
- Personnel in full-time education, working in academia (full-time) or working for a statutory regulatory body may be entitled to a discount on the above fees. Please contact the TOPRA office for details.