Session on Medical Devices

MEDICAL DEVICES SESSION - 28 NOVEMBER 2017

AGENDA

MEDICAL DEVICES SESSION - 28 NOVEMBER 2017

All slides and presentations will be in English

Programme and Speakers:

13:00 Session introduction Annabelle Bruyndonckx, BRAS Education Group

A.  Recent developments at the Belgian level

13:05 Auto control (presentation + demo portal)
          Ethel Mertens, DG Inspection, ad interim and Mathieu Royal, Support Management, Federal Agency for Medicines and Health Products

13:50 Changes in distribution channels
          Katrien Martens – Federal Agency for Medicines and Health Products

14:00 Competence for IVDs
          Jeroen Poels, Federal Agency for Medicines and Health Products

14:10 Materiovigilance: changes with respect to incident reporting
          Kelly Decaluwé, Federal Agency for Medicines and Health Products

B.  Pre-marketing : Inspections of Sponsors and Investigators

14:20 Inspections of Sponsors and Investigators
          Tim De Schutter, Federal Agency for Medicines and Health Products

15:00 Coffee break

C.  Medical technologies Pact

15:30 Current state of the situation
          Marnix Denys, Director beMedTech

D.  Recast

16:00 Impact of the Medical Devices Regulation on economic operators
          Katrien Martens, Federal Agency for Medicines and Health Products
          Valérie Nys, Federal Agency for Medicines and Health Products

17:00 Claims Regime
          Annabelle Bruyndonckx, BRAS Education Group, Simmons & Simmons LLP

17:15 Questions & Answers

17:45 End of session – Noëlla Heyman, BRAS Education Group


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 20 November 2017 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 20/11/2017 or no-show, the fees are due and will be invoiced.

Event info

28 November 13:00 » 28 November 17:45

Location
De Montil - Moortelstraat 8 - 1790 Affligem

Language
English

Member price
€ 150.00

Non-member price
€ 350.00
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