This course is postponed. For more information please contact firstname.lastname@example.org
This course will give an overview of the current In-Vitro Diagnostic (IVD) Directive and will highlight anticipated future changes in the regulation. The basic philosophy of the existing system, including the definition of an IVD, will be explained, and borderlines to other products such as medical devices and laboratory equipment will be highlighted. The future IVD Regulation, which is substantially different from the current IVD Directive, will be discussed and major changes will be emphasised. The revised classification rules and the new requirements on performance evaluation will be explained.
The role of IVDs in personalised medicine, the benefit/risk based approach and the market approval for IVDs, which is different from those for medicinal products will be discussed. Differences between the EU and US systems for personalised medicine, and the current and new role of notified bodies, standards and Common Technical Specifications will be addressed.
Exercises will enable you to apply the principles learnt.
What You Will Learn
In-Vitro Diagnostic Directive 98/78 EU
Upcoming Changes in the Proposed IVD Regulation
Changed Role for Notified Bodies, Manufacturers and Competent Authorities
Common Technical Specifications
Getting to Market
Who Should Attend
This course is designed for professionals in the medical device, In-Vitro Diagnostic and pharmaceutical industry and regulatory bodies who deal with IVDs now or will deal with IVDs in the near future. Due to a growing demand for personalised medicine, there is a trend that the traditional pharmaceutical oriented companies have to fulfil the requirements of the IVD Directive too. This training course will give the basic knowledge to all involved in the design and marketing of IVDs.
At the conclusion of this course, participants should be able to:
Apply the principles of the existing IVD Directive
Understand the essential requirements of IVDs
Use the risk classification rules and CTS
Be acquainted with the future legislation
Know of the major changes/proposals
Understand the difference in the lifecycle of an IVD and personalised medicine
Address the new role of the Notified Body
Reproduce the major principles of getting to market
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
Hotel & Travel
This course will take place at:
Hotel NH Musica
van Leijenberghlaan 221
1082 GG Amsterdam
Tel: +31 20 79 56 088
DIA room block expired on 20 May 2014. Please contact the hotel for the availability and the best price.
HOW TO GET THERE: From Schiphol Airport, take the Sprinter Lighttrain toward Amsterdam RAI, Almere Oostvaarders or Hilversum. You will arrive at the the RAI train station in 10-14 minutes. From the RAI train station, take bus 62 toward Station Lelylaan and get off at the Bouvigne stop. Continue on Van Nijenrodeweg on foot and then turn left onto Van Leijenberglaan. The hotel will be on your left.