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Satellite Workshop

Clinical Investigation Design

In this session, we will focus on the critical design elements and methodologies for medical device clinical investigations. The workshop is hosted by Ms. Danielle Giroud, who is the convener for the expert group on clinical investigations (TC 194 WG4) and has been leading the update of ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” fourth edition.
 

Learning objectives: This workshop focuses on critical design elements and methodologies for study objectives, endpoints, and study processes with emphasis on achieving regulatory compliance.

Take-home message: A checklist of critical design elements and methodologies.

The number of participants will be limited, so reserve your place when you register for the congress! See the full schedule below.

LabQuality-91
LabQuality-122
Satellite Workshop on Clinical Investigation Design

Wednesday 4 February 2025

15:00–15:45 Basis for good study design for medical device clinical investigations
15:45–16:30 Process of developing your medical device study design
16:30–17:15 Special considerations for AI products
17:15–17:45 Coffee break
17:45–18:30 Special considerations for drug-device combination products
18:30–19:30 How to ensure the study design is adequate for regulatory purposes

Price: 65 € + VAT 25,5%

Location: Original Sokos Hotel Tripla
Fredikanterassi 1 B, FI-00520 Helsinki, Finland

Sign up for the workshop with the Congress registration form.

 

Networking at the event

On Thursday evening you can meet colleagues, network and enjoy the relaxed atmosphere during the congress dinner. The menu is full of delicious Finnish ingredients and flavours with an international twist.

Accommodation

Book your accommodation at the congress venue hotel or one of our recommended hotels!

Congress venue – how to get there?

Labquality Days is held at the Messukeskus Siipi conference centre. The venue is located near Pasila railway station, near to Helsinki city center. It is easy to get there by public transportation form the airport.

Contact us - we're here to help!

If you have any questions, please contact the Labquality Days team, we are happy to help!