People
Conference Hosts
Monica Grekula
Sr Director, Biocompatibility and Toxicology, Veranex
Lina Burman
Sr Manager, Biocompatibility and Toxicology, Veranex
Carl-Johan Zettervall
Sr Manager, Biocompatibility and Toxicology, Veranex
Rose-Marie Jenvert
Manager, Biocompatibility and Toxicology, Veranex
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
Arthur Brandwood
Medtech Regulatory Expert with International Perspective
Beau Rollins
Global Director, Quality Services
Bob Przygoda
Consultant
Cecilia Svedman
Head of Department of Occupational and Environmental Dermatology
Chris Waine
Principal Toxicologist
Erwin Annys
Head of Unit Support and Enforcement
Helena Kandarova
Director, Institute of Experimental Pharmacology and Toxicology, CEM, Slovak Academy of Sciences
Jeffrey Brown
Senior Scientist, Pharmaceuticals and Medical Devices
Jeremy Tinkler
Chair of ISO/TC 194. Regulatory Affairs Director
Katarina Weidmann
Biocompatibility Expert
Kelly Coleman
Senior Distinguished Toxicologist
Lars Magnus Bjursten
Convenor ISO 18562, Senior Professor of Bioimplant Research
Martin Mowitz
Associate Professor
Philip Clay
Senior Principal Toxicologist
Piet Christiaens
Scientific Director
Ron Brown
Toxicologist (former FDA reviewer)
Rona Middlemiss
Director
Sherry Parker
Consultant
Ted Heise
Vice President Regulatory and Clinical Services
Thomas Hartung
Professor
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
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
- D. 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
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
- D. 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