Do regulatory requirements really improve product safety?

What about global harmonization - are we there yet?

The importance of keeping track on the whole process when evaluating biological safety is highlighted. Ensure the benefit-risk ratio being high even after changes have occurred and also during the whole lifetime of the device should not be ignored. Biocompatibility is not a once in a lifetime event. Get insight into planning the biological evaluation within a risk based approach, reducing not only biological testing, thus also, reducing costs and time to market. Inform yourself how to navigate to global success, minimizing business risks due to unknown biological safety requirements, avoid submissions pitfalls. Better safe than sorry, learn and discuss how to manage risks and what your responsibilities are.

It is time to rethink!

Join us to network with global Medical Devices Biocompatibility Professionals, share and discuss experience among colleagues and friends.

We offer you a multidisciplinary event, to come together, to learn and share experience and to relax and enjoy the beautiful city of Gothenburg.

You'll meet these experts

  • Lars M. Bjursten, MD, PhD, Prof. Bioimplant research, Lund University, Sweden. Adj. prof. Bioengineering, University of California San Diego, USA. Convener Swedish technician committees TC 150 and TC 194.
  • Lina Burman, PhD, Material specialist, Maquet Critical Care AB, Sweden. Member of SIS/TK 340 and Swedish expert in ISO TC 194.
  • Ulrika Carlander, Senior Toxicologist, Sound Advice AB, Sweden. Member of SIS/TK 340 and Swedish expert in ISO TC 194.
  • Seth J. Goldenberg PhD, Director of Global Regulatory Strategy with NAMSA and a former member of the U.S. FDA, USA.
  • Hana-Hofman-Hüther, PhD, Dep. Head of in vitro Toxicology and Pharmacology, Eurofins BioPharma Product Testing, Munich, Germany
  • John Iannone, Program Manager - Extractables/Leachables & Special Studies, Toxikon Corporation USA
  • Marie Lodén, PhD, Ass. Prof, Eviderm Institute, Sweden
  • Johanna Löberg, PhD, Product Developer, Dentsply Implants, Sweden.
  • Andy Makin, Managing Director, BA, MSc, CBiol, MSB, European Reg. Toxicologist, CiToxLAB Scantox A/S, Denmark.
  • Barbara Musi, PhD, Senior Research Scientist, Toxicology & Biocompatibility, Life Science & Operations, Medical Products R&D, Baxter, Sweden. Member of SIS/TK 340 and Swedish expert in ISO TC 194.
  • Erik Nilebäck, PhD, Application Specialist, Biolin Scientific, Sweden.
  • Albrecht Poth - PhD, Scientific Director, Eurofins BioPharma Product Testing, Munich, Germany
  • Paulo Pescio - Medical Device and GLP Division Manager, Eurofins BioPharma Product Testing, Milano, Italy
  • Mr. Henry Sibun, BSc (Tech) Hons, MSB CBiol, MCQI CQP, Henry Sibun Ass. Ltd. External Aud./Rev. for TϋV SϋD Prod. Service GmbH, UK.
  • Karin Svens, PhD, COB CSO, Inhalation Tox, Toxicology Knowledge Team (TKT), Sweden.
  • Lise Vanderkelen, PhD, Ir. Study Director, Toxikon Europe NV, Belgium.
  • Klaus Weber - PhD, CEO, Anapath GmbH Switzerland
  • Hans P.  Wendel  PhD, University Hospital Tuebingen, Dept. Cardiovascular Surgery, Germany.
  • Ola Winqvist M.D, PhD Professor, Karolinska University Hospital, Solna, Stockholm, Sweden

Pick your favorite topic:

  • Update from the ISO TC 194 (ISO 10993) Meeting in Lund - Current status and upcoming changes. Including ISO basics within evaluation on biocompatibility.
  • How to conduct and plan a toxicological and biological evaluation when heading for a world-wide submission. What about global harmonization?
  • Chemical characterization, ISO 10993 -1/ISO 10993-12/ISO 10993-18 including case studies about analytical results obtained for certain type of devices.
  • Alternative toxicity testing for Medical Devices, focus on irritation and sensitization.
  • Pitfalls of implantation studies. Photographs on the pitfalls and ideas how to move the standard in the right direction.
  • Hemocompatibility testing in the 21st Century: Options and pitfalls.
  • Industry perspective on blood compatibility tests.
  • Immunotoxicity in relation to Medical Devices.
  • Topical products; Pros and cons for medical devices, cosmetics and pharmaceuticals?
  • Inhalation - update - Biocompatibility of respiratory gas pathways.
  • Biocompatibility from a Notified Body perspective.
  • Sterilization of Medical Devices.
  • The evaluation of colorants, pigments and dyes in medical devices; how to avoid submission pitfalls.
  • Different approach due to nanomaterials?
  • The effect of bimolecular interaction and chondrocyte adhesion to surface grafted hyaluronan layer.
  • Emerging & re-emerging markets: how to navigate innovation through global regulatory approvals.

Further information can be found here.