Alphatopics GmbH

Dr. Lutters is scheme manager and technical expert for medical devices within BSI Healthcare, Germany. She has over six years' experience within different Notified Bodies with as main focus the CE-marking of high risk medical devices, including drug-device combinations. Prior to working for BSI she completed a Master in Medical Biology (University of Utrecht, The Netherlands) a PhD in Biochemistry (Utrecht University, The Netherlands).

Ms. Jamieson is a pharmacist with PhD in Targeted Drug Delivery. Following a 2-year post Doc, Janine joined MHRA (then MCA) in 1997 as a pharmaceutical assessor for licensing of new and abridged medicinal products. In 2001 she became involved in assessment of the quality of drug substance aspects of Devices incorporating ancillary medicinal substances and has built up experience in the area of Notified Body Consultations over the following years. Along with Liz Baker, Group Manager at MHRA, Janine is now one of the main contacts regarding the Notified Body Consultation procedure.

Manfred Guelcher graduated in Electronic Engineerin. He is a founder and Co-Managing Director at QualiMed Innovative Medizinprodukte GmbH and is a specialist in regulatory affairs and development of Drug Combination Devices. QualiMed started in 1997 with development, OEM manufacturing and CE approval of implantable and various catheter based minimal invasive medical devices. Headquartered in Winsen, Germany, Current developments are focused on biodegradable materials and technologies.

Dr. Hoffmann studied chemistry, he obtained his PhD in macromolecular chemistry at the Technical University of Aachen (RWTH), Germany. In 1999 he founded the Haemoteq GmbH. Today he is chairman of Haemoteq AG, Hemoteq is the leading designer and manufacturer of customized coatings for medical devices, such as intelligent drug delivery coatings, hemocompatible surfaces and lubricious coatings lay the foundation for integrated combination products of the next generation - adaptive biodevices.

Dr. Kloth obtained her PhD in Immunology and Cell Biology before she became a professor for anatomy at the University of Regensburg, Germany were she is still doing academic teaching. At TUEV SUED she is a Senior Product Specialist for Medical Devices obtained from animal origin. She is heading various expert committees, such as CEN TC 316 Tissue Product Safety, ISO TC 150 SC7 WG1 and TC 194 SC1 WG1 Biological Safety; she is member of the TSE Working Group of the EU Commission.