DIA
Drug Information Association Logo

EU Regulation of In-Vitro Diagnostics (IVDs)

Jun 26 2014 8:00AM - Jun 26 2014 5:00PM | NH Musica van Leijenberghlaan 221 1082 GG Amsterdam Netherlands

« Back to Listing

Overview 

This course is postponed. For more information please contact diaeurope@diaeurope.org 

 

NEW OFFERING!

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
  • Self-Testing
  • Performance Evaluation
  • Essential Requirements
  • Getting to Market
  • Personalised Medicine

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.

Learning Objectives 

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

The Netherlands

Tel: +31 20 79 56 088

E-mail: nhmusica@nh-hotels.com

 

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.

Contact Information 

This course is postponed. For more information please contact diaeurope@diaeurope.org

DIA Europe
Kuechengasse 16
4051 BASEL
SWITZERLAND

TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: diaeurope@diaeurope.org

Faculty 

Previous Next

Registration Fees 

Member

Charitable Nonprofit/Academia Member
€400.00
Member Government
€400.00
Member Standard
€800.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€530.00
NonMember Government
€530.00
NonMember Standard
€930.00
Register Online
« Back to Listing Back To Top