(Itingen, Switzerland; September 10, 2013) — An informative seminar exploring registration of new medical devices in both European and non-European countries will be held twice, once on September 24 in Derby, U.K., and once on September 26 in Darmstadt, Germany. The free seminars, sponsored by Harlan Contract Research Services (CRS), feature industry-leading speakers and tours of Harlan CRS’ advanced laboratories in Derby and Darmstadt.
“We are pleased to be able to offer these informative seminars for our colleagues in research and development and are proud to show off our facilities,” said Harlan CRS President Manuela Leone. “We hope many people will see the value of this information and attend.”
The seminar includes talks on five topics:
- Biocompatibility: Basic in vivo test systems and supplemental long-term studies under consideration concerning animal welfare
- Cytotoxicity: The importance and meaning of medical device testing
- Biological evaluation of medical devices based on ISO 10993-1, 17 and 18 and updates and recent changes in the ISO 10993 series
- Registration in the U.S.
- Medical device registration in the E.U. – The new harmonized E.U. legislation
Speakers from Harlan CRS include Robert Guest, head of global and alternative toxicology; Dr. Ingrid Haist, expert biocompatibility consultant; Andreas Heppenheimer, study director for cytotoxicity and alternative methods; and Dr. Albrecht Poth, deputy managing director and scientific advisor. Guest speakers at the seminar include Dr. Sylvana Mueller, managing director, FORIM GmbH, and Isabelle Lang-Zwosta, project manager, clinical trials and medical devices, FORIM GmbH.
“Along with toxicology and environmental science, regulatory services is one of Harlan CRS’ key strengths,” Leone said. “These seminars offer a valuable opportunity to learn from and interact with industry leaders.”
For more information or to register, visit the Harlan CRS website.
About Harlan Contract Research Services
Harlan Contract Research Services (CRS), a division of Harlan Laboratories, Inc., is a privately held provider of preclinical and nonclinical safety testing services to the global chemical, agrochemical and biopharmaceutical industries. With laboratory locations in Germany, Spain, Switzerland and the UK, Harlan CRS’ focus is on providing customers with services to optimize product development. For more information, please visit www.harlan.com/crs.
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