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5th Annual BTEL Summit & Exhibition

April 24, 2024
April 26, 2024

Prague, Czechia
Occidental Praha

Katrien Salens
+32 16 40 04 84
[email protected]

We are pleased to announce we will be attending the “5Th Annual BTEL Summit & Exhibition”. This event takes place in the Occidental Praha, Prague, Czechia on April 24-26, 2024.

On the first day, attendees will delve into biocompatibility in medical devices, exploring areas such as testing protocols, regulatory frameworks, risk-based approaches, and the pivotal ISO 10993-18 guidelines. Day two focuses on Extractables and Leachables (E&L), providing attendees with insights into analytical strategies, risk-based programs, and advancements within the industry. Finally, day three will concentrate on toxicology, addressing crucial aspects such as product safety, risk assessment, and navigating the diverse regulatory landscape across different product categories.

Our Scientific Expert, Koen Van der Plas, MSc, will give a presentation on “E&L on combination products: testing in between regulations for pharmaceutical products and medical devices” on April 24 at 12h10.

The path to regulatory approval of a combination product can be complex and challenging. Understanding the regulatory landscape and making informed decisions are key for a successful submission. This presentation will delve into the different aspects that need to be considered when performing E&L studies on combination products. Questions/concepts as ‘what is the primary mode of action?’, ‘which extraction conditions do I need to use?’, ‘how low do I need to go?’, the use of uncertainty factors, etc. … will be discussed in detail from an E&L perspective. Supplementary, and to clarify these concepts, some performed and ongoing Nelson Labs E&L studies on combination products will be presented.

Register now: https://bcf-events.com/single-conference/5th-annual-btel-summit

For more information and the program click here.