Biocompatibility Matters 2022
Date/TimeDate(s) - October 4, 2022 - October 6, 2022 All Day
LocationIDA Conference Centre
Kalvebod Brygge 31-33
Join NAMSA at Biocompatibility Matters 2022 in Copenhagen, Denmark on 4-6 October. This event offers a full day of training focused on ISO 10993 parts 1, 17 and 18, as well two days of conferences covering topics from regulatory expectations to best practices for conducting biological evaluation. Networking opportunities with fellow medtech industry professionals will also be available throughout the event.
NAMSA EDUCATIONAL SESSIONS
presented by Alexander Hermann, PhD; Supervisor, Laboratory Services
Strengths and Weaknesses of ISO 10993 as a Regulatory Tool
presented by Michelle Kelly, BSc, MSc, ERT; Toxicologist
Towards a New Biological Evaluation Paradigm
featuring Michelle Kelly, BSc, MSc, ERT; Toxicologist
NAMSA’s MedTech experts will be available on-site for consultations. We welcome the opportunity to discuss the various pathways to market and suggestions on how to most efficiently and cost-effectively achieve market success based on your unique project objectives. Please contact us to reserve your consultation time.
Alexander Hermann, PhDSupervisor, Laboratory Services
Alexander Hermann started his career at NAMSA in June 2020 as a Chemist in the Study Director Team in Germany. Shortly after, he took over as group leader and became Supervisor of the Study Director Team in September 2021. He has specific expertise in chemical characterization programs based on ISO 10993-18, as well as U.S. FDA and other country expectations for the development of study designs and chemical characterization testing. Alexander holds a Master’s degree and PhD from the University of Würzburg (Germany).
Michelle Kelly, BSc, MSc, ERTToxicologist
Prior to joining NAMSA in 2021, Michelle worked at the UK Competent Authority, The Medicines and Healthcare products Regulatory Agency (MRHA), for 14 years as head of biological safety. Her overall responsibility focused on the conduct and outcome of biological safety assessments undertaken by the MHRA, including review of clinical investigation applications, assessment of derogation and exceptional use requests, as well as management of major adverse events related to biological safety which carried significant public health implications.
Michelle is currently the chair of the National Committee for the Biological Evaluation of Medical Devices (CH/194). This committee is working at an international level to represent the UK in the development of key horizontal standards, including ISO 10993 series and ISO 14155. This work is striving for a standardized approach to biological and clinical evaluation of medical materials and medical devices. She is also a European-registered Toxicologist.