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Open House Leuven – Biocompatibility through chemistry: the future of chemical characterization

Event

February 28, 2019

Price

Free of charge

Location

Brabanthal
Brabantlaan 1
3001 Leuven
Belgium

Meeting room Terra

Contact Information

Contact
Katrien Salens
Ksalens@nelsonlabs.com
+32 16 40 04 84


This one-day event will present a unique opportunity to broaden your understanding of how Chemical Characterization for Medical Devices can fit into your overall biocompatibility evaluations, and what is state-of-the-art in this new approach. The speakers will address the key theme from many different angles: explaining the basics of biocompatibility testing and how Chemical Characterization fits in, what the ISO standards say, what is state-of the art in Extractables & Leachables testing, the role and views of a notified body, etc…

What’s new in Leuven?

With a history of over 20 years in Extractable & Leachable testing for the Pharmaceutical and Medical Device Industry, Nelson Labs Europe has become the premier testing lab offering unparalleled science combined with a paramount service. We’ll now introduce you to our NEW Medical Device Line for Chemical Characterization. This represents an exiting milestone, as we take a leap into the future and reconfirm our global leading position in Extractables & Leachables Testing. The Medical Device Line for Chemical Characterization is unique in its kind, as it combines state-of-the art instrumentation (a.o. Accurate Mass platforms), unparalleled quality in science, high throughput automation and comprehensive reporting.

The tour in our laboratories will tell it all!

What sets us apart?

This new Medical Device Line for chemical Characterization is built around the unique Nelson Labs Compounds Screener database. Over the last 12 years, Nelson Labs Europe gradually built this database, based upon Extractable and Leachable compounds which were detected in thousands of E/L studies. Today, over 5000 compounds are in the database, of which the identity is confirmed with authentic standards. As a consequence we can guarantee a fast and accurate identification, and we’ll be able to provide you with quantitative results (response factor correction of all individual entries in the database) on all identified compounds allowing a subsequent in-depth toxicological assessment.

Program

The program starts at 8:50 AM (welcome & registration at 8.30 AM) on February 28, 2019 and includes:

Current Successes and Vision for the Future

Keynote Speaker: Ron Brown (ex-FDA)

Developing biocompatibility for medical devices

Incorporating E&L, ISO, FDA and MDR requirements

Speaker: Audrey Turley
Nelson Labs
(B.S., RM (NRCM), CBA(ASQ), Senior Biocompatibility Expert)

MDR – A Notified Body Perspective

Speaker: Dr. Julian Kirch
TÜV SÜD Product Service GmbH

Medical Device Line for Chemical Characterization: Moving beyond state-of-the-art (techniques & instruments)

Combining unparalleled Quality with High Capacity and Throughput. Including Nelson Labs’ Unique Compounds Screener Database (The Engine of the Nelson Labs Extractables and Leachables Programs)

Speaker: Dr. Piet Christiaens
Nelson Labs Europe
(TC 194 member, Scientific Director)

Speaker: Dr. Annelies Vertommen
Nelson Labs
(TC 194 member, Senior Study Director)

Submission Requirements for Chemical Characterization Studies of Medical Devices – Notified Body Perspective

Speaker: Dr. Julian Kirch
TÜV SÜD Product Service GmbH

Important aspects and approaches in carrying out a toxicological risk assessment on E&L for medical devices with focus on requirements of the MDR

Speaker: Dr. Albrecht Poth 
(TC 194 member, Senior Toxicologist, Knoell Germany GmbH)

A manufacturer’s view on how chemical characterization fits into the overall biocompatibility assessments

Speaker: John Iannone
iCG Solutions
Principal Consultant

Guided tour of the lab facility

Register