BRAS Session on Medical Devices

Save the date of 13 December 2018 for a session on Medical Devices

agenda

Medical Devices session 13 December 2018

All slides and the presentations will be in English

Warning: the session will start at 13:00

Programme and Speakers:

13:00 Session introduction Annabelle Bruyndonckx, BRAS Education Group

A.    Industry perspective

13.05 – 13.25 Medical Devices: Priorities for the next legislature
                       Marnix Denys – Director beMedTech

B.    EU-Medical Devices Regulations (MDR-IVDR)

13.25 – 14.25 Placing medical device Class I and Custom made on the market under the regulation
                       Katrien Martens - Federal Agency for Medicines and Health Products

14.25 – 14.40 Reprocessing of single use devices – State of play
                       Richard Van den Broeck - Federal Agency for Medicines and Health Products

14.40 – 14.55 Impact of the Regulation on clinical investigations
                       Steve Eglem - Federal Agency for Medicines and Health Products

C.    Recent developments at the Belgian level

14.55 – 15.25 Reorganization of the DG Inspection
                       Katrien Martens - Federal Agency for Medicines and Health Products

15.25 – 15.55 Coffee break

15.55 – 16.05 New distribution channel for medical devices and medical devices campaign
                       Katrien Martens & Alexandre Jauniaux - Federal Agency for Medicines and Health Products

16.05 – 16.35 Service and technologies home assistance
                       Richard Van den Broeck - Federal Agency for Medicines and Health Products

16.35 – 16.50 Web applications for actors related to medical devices
                       Alexandre Jauniaux - Federal Agency for Medicines and Health Products

D.    EU-Medical Devices Regulations (MDR-IVDR)

16.50- 17.20 Recast – state of play
                     Valérie Nys - Federal Agency for Medicines and Health Products

17.20 Questions & Answers

17.45 End of session – Ann Osselaere

Registrations through our website. (www.bras-org.be)

For registration you click on the line of the session in “Future courses and events” on the Home Page and then sign up. If you are not yet registered on the website you will be asked to do so. The system will send you a confirmation of registration with payment modalities by return mail.

If you need more assistance please contact Brigitte at bras@bras-org.be or call her on 02.757 06 29.

Fees: BRAS member 150€ - Non-BRAS member 350€

It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 5 December 2018 or no-show, the fees are due and will be invoiced.

 

Program and speakers

Download program

If you need more assistance, please contact Brigitte Frenay at bras@bras-org.be or call her on +32 2 757 06 29.

It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 05/12/2018 or no-show, the fees are due and will be invoiced.

Event info

13 December 13:00 » 13 December 17:45

Location
De Montil, Moortelstraat 8 - 1790 Affligem

Language
English

Member price
€ 150.00

Non-member price
€ 350.00