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1st Day

Regulation and Investment related to Point of Care Diagnostics

Wednesday afternoon, 25th of October 2023

Dear colleagues, dear past and new participants,

Additionally, to the innovation aspects of this symposium, we aim to provide insights on the challenging aspects of regulations (In Vitro Diagnostic Regulation) and investment. Through stakeholders’ feedback and opinions, we bring insights into the compliance with applicable regulations and on the key factors that may trigger a successful investment.

We look forward to meeting you and enjoying an exciting symposium program and good networking!

1st Day | Confirmed Speakers

Latest update: 06.09.2023

Dr. Julianne Bobela

Dr. Julianne Bobela

Senior Consultant | Medidee

 

Title:
Opportunities in filling data gaps for legacy product.

 

Dr. Laura Scrivano

Dr. Laura Scrivano

Team Leader | TÜV SÜD Product Service

 

Title:
POCDx: What is special in the assessment of the design, usability and performance?  Lessons learned from the first conformity assessment.

 

Dr. Andreea Wiese

Dr. Andreea Wiese

Head of Partnering for Point of Care | Roche Diagnostics

 

Round table discussion during the Investment Session

 

Dr. Vincent Zwaans

Dr. Vincent Zwaans

COO | Loop Medical SA

 

Manufacturer’s experience on the search of investment

Round table discussion during the Investment Session

 

Dr. Iwan Märki

Dr. Iwan Märki

CTO and Co-Founder | Abionic

 

Manufacturer’s experience on the conformity assessment process under IVDR

 

Dr. Kim Rochat

Dr. Kim Rochat

Senior Vice President - Regulatory Clinical Quality | Medidee, Veranex

 

Title:
Interoperability and compatibility: challenges when using POCDx.

 

Dr. Benjamin Ricken

Dr. Benjamin Ricken

Head of Point of Care and Self Testing Development | Bühlmann

 

Introduction and chair of the Investment Session.

 

Dr. Silvia Anghel

Dr. Silvia Anghel

Associate Director | Medidee

 

Title:
Point of Care Diagnostic: Current challenges in the European Landscape: Regulation and Investment.

 

More to be announced…