IATP satellite symposium
Tuesday 26 September 2023
The IATP Symposium will be organized in the Hyperion Hotel in Basel.
Messeplatz 12, Basel, Switzerland 4058
T: +41 61-560-4000
Medical Device Safety Assessment: Pathology and Toxicology Perspectives
The global medical device (MD) industry continues to grow due to significant rise in use of medical devices as an interventional therapy or delivery tool. The preclinical development process of safety assessment of medical devices is unique, ever evolving to meet the regulatory requirements that are often different from that of other modalities. This symposium provides an overview of the current status, recent advances, and future trends on the following topics in Medical Device Safety Assessment.
- Toxicology perspectives on medical device safety assessment
- Fundamentals and challenges associated with microscopic evaluation and biocompatibility
- Artificial Intelligence (AI) and Machine Learning (ML) for image analysis and interpretation of MD-associated pathological findings
- Novel applications of currently existing MD for emerging therapeutic modalities
- Extractables and leachables
- Regulatory requirements and differences with various agencies
- Dr. Antoine Alves, NAMSA, Lyon, France
- Dr. Flora Wegener, Fresenius Kabi, Bad Homburg, Germany
- Dr. Nicole Soucy, Boston Scientific, MN, USA
- Dr. Uta Bussmeyer Merz Aesthetics GmbH, Frankfurt, Germany
Draft Program Outline
08.00 - 08.30 | Registration IATP Symposium
08.30 - 08.40 | Welcome and Introduction | IATP Education Committee
08.40 - 09.30 | Toxicology Perspectives on MD Safety Assessment Requirements and Biocompatibility | Dr. Nicole Soucy, Ph.D.
09.30 - 10.20 | Focus on bone implant pathology: a workup, shortfalls and forecasts | Dr. Antoine Alves
10.20 - 10.50 | Extractables and leachable testing of medical devices | Dr. Flora Wegener, Ph.D.
10.50 - 11.20 | Coffee Break
11.20 - 11.50 | Regulatory requirements and differences with various agencies and Regulatory differences in USA, Canada, Europe Including non-animal testing assays/approaches | Dr. Uta Bussmeyer PhD
11.50 - 12.25 | Panel Discussion
12.25 - 12.30 | Closing Remarks | IATP Education Committee
12.30 | Lunch
IATP Symposium € 180
Prices are incl. 7,7% Swiss VAT
The registration fee includes
• Admission to the IATP scientific sessions
• Coffee break
How to register
In order to register for the IATP Symposium and / or the ESTP congress please register online and be sure to submit your registration. Upon receipt of your completed registration form and payment, you will receive an email confirmation of your registration.