Qarad 2nd EU IVD-Regulation Conference

May 5, 2017 was a day to remember: The official publication of the new European Regulations for In Vitro Diagnostic Medical Devices!

Since it will be an extensive transition from the current Directive to the Regulation, Qarad feels it as an honor to guide you in this process.
That is why we would like to offer a two-day conference entirely focused on the new IVD-Regulation. Our experts, Dirk Stynen & Maurizio Suppo, and guest speakers will be pleased to transfer all their knowledge onto you.

 

Program

October 18th: Meet the new EU IVD-Regulation

8:30 - 9:00

 Registrations 
 
9:00 - 9:15   

 Welcome
   

9:15 - 10:30

 A General Overview



 Understanding the Transition Period

10:30- 11:00
 Coffee Break

11:00 - 12:30

 Classification and Conformity Assessment Procedures



 Clinical Evidence

12:30 - 13:00

 Lunch

13:00 - 15:00

 Global Safety and Performance Requirements



 Part 1 Analysis of new IVD-R features impacting:
  • Role of Harmonized Standards
  • Common Specifications
  •  UDI Requirements
  •  Economic Operators and Single Registration Numbers - Who are they and how to work with them?
  •  LDTs and Lab test services
15:00 - 15:30
 Coffee Break

15:30 - 17:30

Part 2 Analysis of new IVD-R features impacting:
  • Analysis of exemptions
  • Companion Diagnostics
  • Classification
  • Special Conformity Assessment Procedures
  • 3rd Party Management - How to prepare a RAQS Annex and what to include in it?

Take Away Points

  

October 19th: Practical workshop on key aspects of the EU IVD-R


8:30 - 9:00   
Registrations

9:00 - 10:30





Clinical Evidence
    • What is required?
    • What are the elements of Clinical Evidence?
    • How to build a solid set of documentation on Clinical Evidence?
10:30 - 11:00 Coffee Break

11:00 - 12:30
Working with Notified Bodies
      • How to interact with them?
      • How to understand how they work?
      • What are their expectations?

12:30 - 13:30


Lunch

13:30 - 15:00
Design Control and Risk Management as per the IVD-R     
    • How to design and implement a robust and compliant Design Control and Risk Management Process?
    • What are the requirements?

15:00 - 15:30

Coffee break

15:30 - 17:00
Medical Vigilance and Post Market Surveillance   
    • How to navigate throughout the requirements?
    • How to build a robust Vigilance and PMS Process?
    • What are the Notified Bodies' expectations?


e-IFU live demo

Next to major changes on regulation, also the requirements regarding Instructions for Use (IFUs) has changed.
As off now, you must set up a system to make the IFU’s available on your website.
Why not turn this obligation into an opportunity and leave out the paper IFU’s at the same time, saving on paper and logistics cost?
At Qarad we are convinced that our e-IFU Service offers the perfect solution!

If you are interested, our e-IFU team will also be present at our conference. They will be pleased to present our e-IFU Services throughout our conference days.

If you want to schedule a live demo, please contact us.

 

Practical

Location

The conference will be held at the Courtyard by Marriott Brussels.

Address

Courtyard by Marriott Brussels

Avenue des Olympiades 6

1140 Brussels

Belgium

Date

October 18 - 19, 2017

Price and registration

Pricing for two day attendance

€1000 for early birds     Registration before August 31st

€1200 for regulars         Registration between September 1st - September 30th

€1400 for late comers    Registration between October 1st - October 10th

To register for both daysclick here


Pricing for one day attendance (either October 18 or October 19)

€600 for early birds       Registration before August 31st

€800 for regulars           Registration between September 1st - September 30th

€1000 for late comers    Registration between October 1st - October 10th

To register for just one day: click here


Registration is only confirmed after receiving the payment.


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