People
Conference Hosts
Program Advisory Committee
- Ted Heise, Vice President, Regulatory and Clinical Services at MED Institute, Convenor 10993-18, US
- Arthur Brandwood, Medtech Regulatory Expert with International Perspective, Australia
- Sherry Parker, Sparker Consulting, US
- Ron Brown, Toxicologist at Risk Science Consortium (former FDA reviwer), US
- Lars-Magnus Bjursten, Senior professor Bioimplant Research. Convenor ISO 18562 series, SE
- Philip Clay, UKRT, ERT, Senior Principal Toxicologist, Chorley Consulting Ltd, UK
Conference Speakers
Helena Kandarova
Director, Institute of Experimental Pharmacology and Toxicology, CEM, Slovak Academy of Sciences
Arthur Brandwood
- Project leader for the current revision project of ISO 10993-1
- 40+ years of experience in the medtech and therapeutics industry in Europe, Australia, and Asia
- Active participant in ISO 109993 standards development from the founding of the ISO committee 30 years ago
Beau Rollins
- Experience working for a contract lab, contract manufacturer, and medical device manufacturers
- ISO delegate for ISO 10993
- US co-chair for nanomaterials
- US AAMI member for ISO 11135 and ISO 11737
- Member of the Society of Toxicology
Bob Przygoda
- PhD in microbiology and molecular genetics
- Manager of the Genetic Toxicology Group at Exxon Biomedical Sciences
- Study director for genetic toxicity tests for 15 years
- Chair of the American Industrial Health Council’s Mutagenicity Sub-Committee
- Served on board of directors and president of Genetic Toxicology Association
- Retired in 2018 and currently serves as an independent consultant
- US expert for TC/194 subcommittee (WG6) on ISO 10993-3
Cecilia Svedman
- Member of the European Environmental Contact Dermatitis Research Group
- Member of the Swedish Contact Dermatitis Research Group
- Swedish representative of the European Society of Contact Dermatitis
- Running clinical study on adverse skin reactions to medical devices
Chris Waine
- Principal Toxicologist at Bibra Toxicology Advice & Consulting
- 12 years of experience in human health hazard & risk assessment
- European-registered toxicologist
- Chartered chemist
- Member of the Royal Society of Chemistry
Elisabet Jamez
- 5+ years of experience in the medical device testing field, specializing in Extractables & Leachables, and biocompatibility.
- Writes biocompatibility assessments targeted for regulatory submissions worldwide.
- Regularly presents on manufacturing residues cleaning evaluations and biocompatibility at Nelson Labs seminars.
Erwin Annys
- Observer in the Competent Authorities Meeting for REACH and Classification and Labelling
- Director of REACH/Chemicals policy
- Sherpa in the Directors Contact Group
- Head of Unit Support and Enforcement at ECHA
Helena Kandarova
- Director of the Institute of Experimental Pharmacology and Toxicology at the Centre of Experimental Medicine, Slovak Academy of Sciences in Bratislava
- Lecturer at the Faculty of Chemical and Food Technology in Bratislava
- Established and led MatTek In Vitro Life Science Laboratories in the EU for 10 years
Jeffrey Brown
- 15+ years of experience supporting industries, researchers, regulators, and test method developers involved in replacing the use of animals in compulsory regulatory submission
Jeremy Tinkler
- Chair of ISO/TC 194: Biological and Clinical Evaluation of Medical Devices
- Regulatory Affairs Director, Strategic Regulatory Services — Medical Devices at ICON plc.
Katarina Weidmann
- Expert for Biocompatibility at TÜV SÜD
- Deputy SPS for Biocompatibility
- Studied at University of Würzburg
- Experience as a study director in the CRO space
Kelly Coleman
- Distinguished toxicologist and Bakken Fellow at Medtronic
- US expert on ISO Technical Committee 194’s working group 11 and working group 8
- PhD. in Toxicology from the University of Minnesota
- European-registered toxicologist and certified in US regulatory affairs for drugs and medical devices
Lars Magnus Bjursten
- Senior professor at Lund University in Sweden
- 30+ years of experience working with biological safety standards
- Convener for the working group responsible for ISO 18562 Standard
- Head of the Swedish delegation and chairman for the mirror committee to ISO TC194
Martin Mowitz
- Chemist at the Dept. Of Occupational & Environmental Dermatology
- Nearly two decades of experience with contact allergy investigations and research
- Recent focus has been investigations of allergic contact dermatitis caused by medical devices for diabetes patients
- Responsible for chemical investigations leading to detection of several important culprit allergens
Natascha Arnauts
- Master’s degree in industrial engineering and Biochemistry; began working at Nelson Labs in 2021.
- Advises customers on healthcare reprocessing validations for reusable medical devices and biocompatibility, with a focus on cytotoxicity testing failure investigations.
- Regularly presents at various Nelson Labs seminars across Europe.
Philip Clay
- Principal Toxicologist with Chorley Consulting
- UK- and European-registered toxicologist
- 30+ years of experience in toxicology and safety assessment
- Committee member on CH/194, UK Principal Expert for WG6, UK Registered Toxicologist Panel
- Experience within agrochemical, chemical, pharma, and medical device industries
Piet Christiaens
- Launched Extractables & Leachables lab testing nearly 25 years ago
- Given 200+ presentations on aspects of E/L testing
- Led 30+ two-day E/L training sessions
- Currently involved with numerous standard-setting organizations to guide chemical characterization of medical devices and develop robust approaches for E/L testing in pharma applications
Ron Brown
- 35+ years of experience in regulatory toxicology and risk assessment
- Retired from US FDA after 25 years
- Currently directs a small company that provides toxicological consulting
- Leader of the Laboratory of Biological Risk Assessment
Rona Middlemiss
- Director of Chorley Consulting
- UK- and European-registered toxicologist
- 8+ years of experience with medical device safety assessment
- Extensive experience preparing Biological Evaluation Plans and Reports, plus Toxicological Risk Assessments of medical device leachates
- Involved in successful regulatory submissions with EU MDR and US FDA
Sherry Parker
- 25+ years of experience in toxicology and medical devices
- PhD. in Molecular and Cellular Pharmacology from the University of Miami
- Currently independent medical device toxicology consultant
- US co-chair of the AAMI/Biological Evaluation Committee and ISO expert of the working groups for ISO 10993-1 and ISO 10993-17
Ted Heise
- Vice President of Regulatory and Clinical Services at Cook MED Institute
- 30+ years of experience in regulatory and clinical affairs
- PhD in Analytical Chemistry
- US delegate to ISO TC 194 for the past 15 years
- Member of USP expert committee on packaging
Thomas Hartung
- Doerenkamp-Zbinden-Chair for evidence-based toxicology in the Department of Environmental Health and Engineering at Johns Hopkins Bloomberg School of Public Health and Whiting School of Engineering
- Adjunct affiliate professor at Georgetown University
- Joint appointment as Professor of Pharmacology and Toxicology at University of Konstanz, Germany
- Director of Centers for Alternatives to Animal Testing
- Authored more than 675 scientific publications with more than 47,000 citations
Monica Grekula
- Senior director, biocompatibility and toxicology at Veranex
- 25+ years of experience in the medical device industry
- MSc in Pharmacy and MSc in Applied Toxicology
- European-registered Toxicologist
- Member of ISO/TC194 since 2006
Lina Burman
- Senior consultant in biological safety and toxicology at Veranex
- PhD in polymer chemistry with focus on chemical analyses and degradation behavior
- 15+ years working with biological evaluations and toxicological risk assessments of medical devices
- Deep expertise in the evaluation of breathing gas pathway devices
Carl-Johan Zettervall
- Manager of Biocompatibility and Toxicology at Veranex
- 20+ years of experience within the medical device, pharma, and biotech industry
- Experienced method developer of in-vitro methods
- MSc in Molecular Biology
- PhD in Cell Biology
Rose-Marie Jenvert
- Senior consultant in biological safety and toxicology at Veranex
- PhD in cellular and molecular biology
- European-registered toxicologist
- Background in safety assessments of pharmaceuticals and biocompatibility of medical devices
- Focus on toxicological risk assessment on devices where chemical data is available