Conference
Tuesday, October 21, 2008
Chair: Dr. Stefan Menzl, Director, Regulatory Affairs & Clinical Research, Europe / Africa / Middle East, Advanced Medical Optics About the Chair Dr. Stefan Menzl, Director, Regulatory Affairs & Clinical Research After an education in Biology, a Ph.D. in Biotechnology at the Julius Maximilians University in Wuerzburg, Germany and a study in Business Administration, he joined Baxter Healthcare as a Regulatory Affairs Professional. During the spin-off of the Cardio-Vascular Group from Baxter, Stefan resumed responsibility for creating and leading the European Regulatory and Quality department of Edwards Lifesciences. During the five years working for the company he took on additional responsibility for Funding, Reimbursement and Healthpolicy in Europe and the role as Managing Director of the European Service entity of Edwards. Hi current role involves interacting with key personal of Notified Bodies, Competent Authorities and European policy makers and actively shaping the regulatory environment. ________________________________________________________________________________________________________________ Recent Developments in the International Landscape of Medical Devices Regulation: U.S. FDA Perspective Abstract Globalization in the 21st century creates new markets far beyond national markets to other markets around the world. While globalization can bring immense change in the lives of people everywhere, the FDA also continues to face new challenges in regulating medical devices to ensure their safe use. In order to address challenges brought about innovation, improvements, efficiency and the increasing number of new devices entering the marketplace, medical device regulation must be aligned with the future of medical device technology. This presentation will provide an update on some of the FDA device initiatives that have international implications.
About the Instructor Carole Carey, FDA ________________________________________________________________________________________________________________ Changes and impact of the revision of the Medical Device Directive Abstract Revision of the Medical Device Directive (93/42/EEC)
About the Instructor Dr. Stefan Menzl, Director, Regulatory Affairs & Clinical Research After an education in Biology, a Ph.D. in Biotechnology at the Julius Maximilians University in Wuerzburg, Germany and a study in Business Administration, he joined Baxter Healthcare as a Regulatory Affairs Professional. During the spin-off of the Cardio-Vascular Group from Baxter, Stefan resumed responsibility for creating and leading the European Regulatory and Quality department of Edwards Lifesciences. During the five years working for the company he took on additional responsibility for Funding, Reimbursement and Healthpolicy in Europe and the role as Managing Director of the European Service entity of Edwards. Hi current role involves interacting with key personal of Notified Bodies, Competent Authorities and European policy makers and actively shaping the regulatory environment. ________________________________________________________________________________________________________________ Vigilance and adverse event reporting (MEDDEV 2.12-1 rev.5) Abstract This presentation will inform medical device manufacturers on their new and revised responsibilities regarding medical device reporting to the EU. New definitions (e.g. Field Safety Corrective Action, Field Safety Notice, Periodic Summary Reporting, Serious Public Health Threat, Trend Reporting, Abnormal Use etc) will be discussed, as well as the consequences for reporting (when and to whom). The new timelines for reporting will be illustrated with examples. The new Meddev is much more clear on events that need NOT to be reported. Trend reporting is new, including for not-reportable incidents. The roles of manufacturer, Notifies Body and Competent Authority will be clarified. About the Instructor Jeff Schakenraad, Regional Manager, KEMA ________________________________________________________________________________________________________________ Middle East/Eastern Europe Regulatory Requirements in selected countries / acceptance of CE and FDA approvals Abstract The last waves of enlargement of the European Union in 2004 and 2007 brought a deep relief for RA professionals working with Europe, widening the CE mark area by 12 more countries. However, there are still a few European countries which remain outside the EU boarder. They still keep, to a certain level, their own regulatory requirements that often double the conditions of the CE marking. Additionally, just next to the European Union, huge areas with continuously developing markets are intensively attracting the interest of the industry. These regions are much diversified in terms of regulatory requirements as well as by the level of acceptance of the CE mark and/or the FDA approval. Countries of the former USSR and the Middle East are tending to develop regulatory systems that combine the EU and/or FDA approach with local inventions and this often represents a huge challenge for any regulatory professional. With the following presentation, I would like to give you a picture of the regulatory requirements in selected countries/areas of the EMEA based not only on facts that can be found in the official governmental documents (if available) but also very much based on our practical experience. - Europe after the last EU enlargement About the Instructor Momchil Blagoev, Edwards Lifesciences In 1996 Momchil joined the Healthcare Competent Authorities in the Czech Republic. He was an expert responsible for adoption of EU rules governing Biological/Biotech products to the assessment procedures of the Drug Control Agency of the Czech Republic for 5 years. Momchil joined Edwards Lifesciences in 2001 as RA Manager for Central / Eastern Europe, Middle East & Africa, and is responsible of Edwards’s regulatory activities and product regulatory compliance for these regions. He provided expertise to the company’s senior leadership during EU accession of the new Eastern European member states. Momchil recently became Regional Manager EMEA focusing on RA company strategy for the area. ________________________________________________________________________________________________________________ Asia Pacific - changing regulations in selected countries Abstract The session will cover:
About the Instructor Paul Brooks, BSI In 1993 Paul joined BSI Inc. the US subsidiary of BSI, as the local expert on CE Marking under the Medical Devices Directive. During his 6 years with BSI Inc Paul worked with over 300 US medical device manufacturers that were selecting a notified body and beginning the CE Marking process and worked on programs to raise awareness of the new European CE Marking approach in North America. Paul was also called upon to present and provide input in the US Capital on the FDA Modernization Act 1997, particularly regarding the use and role of third parties in regulatory requirements. Paul returned to London 1998 to be Head of Notified Body for BSI's Medical Devices Group, and was regularly involved in European Medical Devices Notified Bodies meetings and technical groups in Brussels with the European Commission. Today Paul is once again located in BSI's Washington DC office and is responsible for leading BSI activities in the medical devices sector on a global basis, including Notified Body, EU/US Conformity Assessment Body, Health Canada / SCC CMDCAS accreditation and US FDA recognition. Paul is a member of the American Society for Quality and Regulatory Affairs Professional Society and holds a degree in Business Administration.
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