09.30 

Dr. Jörg-M. Hollidt | Vorstand DiagnostikNet-BB e.V.

Begrüßung & Einführung IVDR: Rechtliches & Regulatorische Grundlagen

 

10.45 

Kaffeepause

 

11.00   

Lei Yang | NAMSA China (Englisch)

1. China Regulatory and Consulting team introduction

-       Overview of CFDA New Regulations

-       China Consulting Team

-       China Consulting Market Discovery

2. China IVD Regulations Introduction

                           

12.15 

Mittagspause

 

13.15 

Amber Fang | Director of Clinical Research, NAMSA China (Englisch)

1.       Clinical environment in China

-          Regulatory requirement

-          Clinical requirement

2.       Prepare for an IVD clinical trial

-          Study design

-          Hospital selection

-          Timeline and budget

3.       Trial permissions and enrollment

4.       Key points for a successful IVD trial

               

14.15 

Kaffeepause

 

14.30

Gerhard Pieper | Pieper Innovationsgesellschaft mbH

Markterschließung China

GermanTecPort – Innovationen effizient beschleunigen

                                        

Ab 15.00  

Get-together

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