4th Qserve MedTech Conference - Who is prepared for the drastic changes in MedTech regulation?

September 09, 2019 - September 10, 2019 / Europe - The Netherlands, Arnhem

Register by 1 August 2019                                        Register after 1 August 2019

             € 355.-                                                                           € 395.-

Group Rates Available:
Qserve offers discounted group rates for those companies which would like to send multiple employees.

Who is prepared for the drastic changes in MedTech regulation?

Following the success of Qserve’s previous sessions, we extend an invitation to join us at the 4th international Qserve Conference, where a very diverse program will be presented with speakers from the industry, Notified Bodies and Competent Authorities. 

The theme of the conference will be to address not only the EU regulations but to also focus on the broader picture, looking at changes in the US and China and discuss the worldwide registrations that are based on EU or US approval.

The International Qserve Conference will follow a practical approach and demonstrate best practices in the general sessions while offering interactive workshops on various hot topics.

Topics:

MDR:
September 2019 will mark 8 months until the deadline to meet MDR requirements. Learn the steps manufacturers have to go through in the coming months.

What can manufacturers do to minimize the risks of product withdrawal? What is the best practice for clinical data for legacy products? Is there an overall “Plan B” by competent authorities?

IVDR:
80% of IVD manufacturers will be affected by this drastic change.

What are the significant impacts? How should a simple gap analysis be prepared? What details are Notified Bodies expecting to see in the technical file? What and how much clinical performance data is requirered?

FDA:
Qserve has recognized a shift in regulatory strategies. For new devices, manufacturers are more frequently using the FDA pathways as the first regulatory milestone.

What are the different routes for market access when the US is the initial regulatory pathway? What are the requirements for an FDA priority review?


CFDA/NMPA:
In 2020, China will be enforcing new regulations.

As overseas inspections are becoming increasingly important, how should these regulations be approached? Qserve will demonstrate best practices used by our consultants who have been involved in recent manufacturers’ inspections. Will the new regulations further specify the clinical data required, and will the use of overseas data be widely accepted?

Program overview:

Monday 9 September 2019:

13:30h Welcome and Coffee

14:15h Opening & latest news from Brussel  Gert Bos Qserve Group
14:30h  introduction panel members Hulda Hallgrimsdottir  Ossur
    Bassil Akra  TUV SUD
    Sue Spencer  Qserve Group
15:00h  Workshops    
   EU-MDR  Gert Bos,  Qserve Group
   EU-IVDR  Sue Spencer
17:00h  Global Impact Changing regulations for Market Access             
17:30h  Closing Network reception    
19:00h  Diner    

Tuesday 10 September 2019
08:30h  Coffee and start of day 2                                                                     Gert Bos  Qserve Group
09:00h  Workshops    
   Clinical Trial  Wiebe Postma Qserve Group
   PMS/PMCF  Stephanie Valk Qserve Group
     Bassil Akra TUV SUD
   Horizontal elements   Paul van Geffen Qserve Group
     Agnieszka Schreiber Qserve Group
     TBA  Industry
   Auditing & Compliance  Peter Reijntjes Qserve Group
     TBA TBA
   CFDA/NMPA registrations  Xiaoli Gou  Qserve Group
     TBA TBA
   FDA   Susan Klymowski Qserve Group
     TBA  TBA
 13:00h  Lunch    
 14:00h  Panel Discussions    
 15:15h  Wrap up    
 15:30  Closing    
Gert W. Bos, PhD, Fraps
Martin de Bruin
Susan Klymowsky
Jan van Lochem
Stefan Menzl
Wiebe Postma
Stephanie Valk
Post date: May 29, 2019
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