讲演嘉宾
Joris Bannenberg, MD, PhD
Chief Medical Officer, Factory - CRO for Medical Devices, Netherlands
Joris Bannenberg is a medical doctor with a PhD in surgical techniques. He has over 24 years of experience with medical devices in experimental and clinical trials, surgical procedures and implantation techniques and clinical research for medical devices. He has trained over 2500 surgeons in many minimal invasive surgery courses. As medical director/consultant/regulatory affairs he was responsible for many medical device studies for various medical device companies, from small ones to multi-nationals, in several medical specialty fields.
Reinhard Berger, DrSc, MSc
Regulatory Affairs Medical Devices, Consulting-Advising, Austria
Graduated in Physics (PhD), initial research area thin film technologies, then neurostimulation. As leader of the implant team developed innovative cochlear implants including conformity assessment of the CI-system, This device was the first medical device in AT to be CE-marked. Achieved market approvals in most markets. From 2004 to 2019 with the Austrian Authority (BASG, Federal Office for Safety in Healthcare) as Senior Expert, member of various MDEG Was and MDCG. Since 2020 active as consultant and trainer.
Gert Bos, PhD, MSc
Chief Scientific Oficer, Executive Director, Partner, Qserve Group B.V., Netherlands
Gert is an expert in European regulations based on 15 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, head of notified body. He led the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.
Sabina Hoekstra-van den Bosch, PharmD, MSc, RPh
Global Director Regulatory Strategy, Tüv Süd, Netherlands
- >20 years experience as pharmaceutical and medical device regulator in the Dutch government, successively in Medicines Evaluation Board, Ministry of Health and CCMO (governmental organization for clinical investigations) - Lead for European Regulation in Philips (global medtech company), co-leading Philips’ EU MDR/IVDR Implementation Program - Currently Regulatory Strategy Principal in Notified Body TÜV SÜD - Chair of NB-MED (formal EU Commission’s working group of Notified Bodies and Vice-President of Team-NB (association of EU Notified Bodies) - Long track record in global professional organizations DIA and RAPS - Regular speaker and faculty member in educational conferences on regulatory topics - Holding PharmD of Leiden Univer
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