Features a comprehensive program that faces the challenges in relation to biocompatibility today. An impressive list of national and international speakers from notified bodies, agencies, test houses and industry.
Mr. Henry Sibun, Henry Sibun Associates Ltd chairing the Conference day 1 and Dr Albrecht Poth, Dr. Knoell Consult GmbH, acting as Chairman day 2.
Together with good networking opportunities it will certainly be rewarding days in Gothenburg. The conference will enable you to understand the current and future requirements for ensuring the biological safety of medical devices.
Some hot topics: the impact of the new MDR in relation to biocompatibility, update from the ISO 10993 standard series, learn more about animal tissue derivatives and wound healing, and not at least focus on requirements for China. With speakers from two Notified Bodies and exclusive from China FDA.
This is an excellent opportunity to network with global Medical Devices Biocompatibility Professionals, share and discuss experience with colleagues and friends. Whether you work with R&D, QA or Regulatory this is a unique opportunity to learn more. Our primary ambition and focus is to offer you a multidisciplinary event to come together to learn and share experience and where you can also relax and enjoy the beautiful city of Gothenburg. We look forward to welcoming you to this not-to-be-missed event, Symbioteq Biocompatibility of Medical Devices Conference 2017 in Gothenburg.
Put 3-4 October 2017 in your diary and be sure to regularly visit the website for the latest updates.
Limited seats available, reserve your seat now!
Update on the ISO 10993 standard series (what has happened since the last conference October 2014).
– Status and upcoming changes.
Albrecht Poth – PhD, Chairman ISO TC 194 and of the German National Mirror Committee, Convenor of ISO 10993-3, Senior Toxicologist, Business Unit Health Care – Business Development, Dr. Knoell Consult GmbH, Germany
Notified Body perspective on biocompatibility, with the new Regulation in mind.
Notified body perspective on Biological Evaluations, including assessment of the impact of the new General Safety and Performance Requirements in the MDR (e.g. endocrine disruptors and quantitative restrictions) as well as discussion of the overlap between biocompatibility and clinical evaluation e.g. the assessment of equivalency and the pitfalls related therewith (toxicological equivalence, comparability of intended use, potential differences in patient population, etc.).
Dr. Julian Kirch, TÜV SÜD Product Service GmbH, Germany.
Biocompatibility, risk management and the QMS
Cover the biocompatibility process as part of the QMS, biocompatibility within the risk management process and what a Notified Body tends to see.
Henry Sibun, Director, Henry Sibun Associates Ltd, and External Notified Body Reviewer/Lead Auditor for TÜV SÜD Product Service GmbH. UK
Standardization – a powerful tool!
Lena Morgan, Project Manager, Reg Biomedical Scientist, Chair for Advisory Board for Health Standards (ABHS), CEN, Swedish Standards Institute.
Global submission expectations regarding ISO 10993-1 – a manufacturer of active implantable devices’ perspective.
Gerhard Marini, MED-EL, Austria.
Current development and future trend of ISO 10993 standards in China.
Director Chenghu Liu of the Biological evaluation department at China FDA-Shandong Quality Inspection Center For Medical Devices (one of the China FDA medical device testing centers and China TC 194 working group committee).
When Drug meets Device - New challenges for Drug Stability and Material characterization of Combination products.
Key points: *Analytical testing for Combination products. How to approach? *New challenges for Drug stability especially for devices coated with drug products. *Impurities from the drug, the device or the combination?
*The importance of Chemical Characterization (ISO10993-18) and the impact on drug stability – leachables and their interaction with the drug product. *Case studies. The increasing use of and interest in innovative combination products – products combining a drug, device, and/or biologic – is raising significant challenges both for regulators and the industries they regulate.
Using specific case studies, this talk will present the challenges that Toxikon has overcome in drug stability studies as well as well in material characterization of drug/device products from a practical, analytical and regulatory point of view.
Dr. Ir.Lise Vanderkelen, Department Head Pharma Services, Toxikon Europe nv, Belgium.
Medical devices utilising animal tissues / derivatives: a notified body perspective.
Jennifer Durrant, PhD, Certification Lead, General Devices, BSI, UK.
Update on the ISO 18562 standard series “Biocompatibility of breathing gas pathways in healthcare applications”.
Lina Burman, PhD, Consultant, Symbioteq, Sweden.
Hemocompatibility ISO 10993-4, with industry examples from a global perspective.
Barbara Musi, PhD, Principal Research Scientist, R&D and Innovation, Baxter Healthcare Corporation.
Are the current medical device extraction procedures sufficient for genetic toxicity hazard identification?
Extracts prepared according to ISO 10993-12 are used in several genetic toxicity test systems to identify potential hazards. The adequacy of the various extraction procedures allowed in ISO 10993-3 is still being debated. The concern is that these extraction procedures may not be adequate for hazard identification. A comparison of literature data made to determine if the extract concentrations were sufficient to induce a mutagenic response at the lowest positive doses induced by various mutagenic chemicals will be presented. In addition, results from 104 Non-Volatile-Residue tests analyzed to determine the cumulative frequency of non-volatile residues at 6 targeted dose-concentrations (0.001% to 10%). The results were used to determine how often known mutagens could be detected using current ISO 10993-12 extraction procedures.
Robert Przygoda, PhD, Johnson & Johnson, USA.
Wound healing – specific considerations.
Co-chair: Andy Makin, Scientific Director, Director of Business Development and Sales. CiToxLAB Scantox A/S.
Biological safety evaluations for wound care devices: notified body expectations, Jennifer Durrant, PhD, Certification Lead, General Devices, BSI, UK.
Presentation on non-clinical wound-healing studies. CiToxLAB, Denmark
Sterilization and Microbiology. Sterilization area in general and reprocessing of reusable instruments.
Development of an in-vitro testing battery to assess biocompatibility of medical devices.
DI Elisabeth Mertl, OFI Technology & Innovation GmbH, Austria
Chemical characterization, extraction/leaching conditions and biological testing in relation to the TTC concept (Threshold of Toxicological Concern).
Duopresentation. Ulrika Carlander, PhD, Senior Consultant, SoundAdvice AB and Lars Magnus Bjursten, MD, PhD, Professor Bioimplant Research, Lund University. Sweden.
Toxicological Risk Assessment of medical devices based on extractable and leachable data – Lessons learned.
Dr. Anja Rämisch. European Certified Toxicologist, Dr. Knoell Consult GmbH, Germany.