Medical Device Seminar Series - The EU Regulatory Environment 2008Date: Monday, June 9, 2008Time: 8:30AM – 3:30PM Location: Sutton Place Hotel, Ballroom Versailles A Address: 845 Burrard Street, Vancouver, BC V6Z 2K6 Phone: 604.682.5511 Map and Directions Registration Fee: $60member, $90 non-member Click here to register Event Description In the ever-changing world of regulatory affairs, it’s critical that companies stay up-to-the-minute on the requirements to bring a product to market. LifeSciences BC is therefore pleased to offer this event designed to provide the latest information on the regulatory environment in the EU, and review important recent changes made to it. This discussion will be led by Dr .Evangeline D. Loh, Director of Regulatory Affairs, Emergo Group, Inc., and include the following areas: Medical Devices and CE Marking in 2008 There are now 27 EU member states. Discussion of the following topics: CE Marking, medical devices, review of Technical File or Design Dossier, labeling, Own Brand Labeling (OBL) or Private Brand Labeling (PBL), registration requirements in member states, borderline products, ancillary directives (WEEE, packaging and packaging waste), GMDN Codes, et. al. Directive 2007/47/EC Modifications to the Medical Devices Directive In late September, the long-anticipated revisions to the Medical Devices Directive (MDD 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD 98/79/EC) were published in Directive 2007/47/EC, which becomes mandatory on 21 March 2010. There are more definitions, software is a device, there is clarification on combination products, single-use devices, and reprocessing, administrative modifications, closer inspection of design documentation required by the Notified Body, outsourced design and manufacturing need to be more closely monitored, classification changes, IFUs must be revision controlled, records retained for five years, and emphasis on clinical data, including Class I devices. This presentation will highlight the modifications to the directive, and what they mean for device companies. In particular, the emphasis on clinical data will be discussed. Vigilance Competent Authorities are now expecting manufacturers to have a good understanding of post-market surveillance, including vigilance. Notified Bodies and Competent Authorities alike are starting to make this a key element of their inspections and companies must be prepared. Revisions to MEDDEV 2.12-1 rev 5, Guidelines on a medical devices vigilance system, published April 2007 and entered into force on 1 January 2008 will be discussed. There are modified reporting time frames and different categories of events which require reporting. There are new definitions provided, and Field Safety Corrective Action (FSCA) is the moniker for recall. There are also new forms provided with the guidance. Member state Competent Authorities have also variously begun to issue their own guidance on the topic. Speaker Profile Evangeline D. Loh, Ph.D., RAC Director of Regulatory Affairs Emergo Group, Inc. Dr. Evangeline Loh oversees regulatory consulting support for Emergo clients worldwide, and oversees Emergo's European Authorized Representative clients. Prior to joining Emergo Group, Dr. Loh was involved in regulatory affairs for the surgery and critical care units of Cook, Inc. She has extensive knowledge of US and EU regulations, in addition to working on regulatory submissions around the world. Prior to her tenure at Cook, Dr. Loh worked for the Division of Biomedical Sciences at the Association of American Medical Colleges (AAMC) in Washington, DC. Her role there was to develop data metrics and quality control measures, conduct statistical analysis to evaluate the performance of clinical sites, and to manage graduate education policy. As a graduate student at the University of Texas Health Science Center at San Antonio, Dr. Loh designed and implemented research protocols to conduct experimental research using complex molecular techniques. She obtained a BS in Microbiology from Cornell University, a PhD in Pharmacology from the University of Texas Health Science Center at San Antonio, and holds the RAC (US, EU) designation from the Regulatory Affairs Professional Society. Agenda 8:30-9:00AM: Registration and breakfast 9:00AM-10:30AM: Medical Devices and CE Marking in 2008 10:30-10:45AM: Coffee break 10:45AM-12:00PM: Directive 2007/47/EC Modifications to the Medical Devices Directive 12:00-1:00PM: Lunch 1:00-3:00PM: Vigilance 3:00-3:30PM: Q&A, Discussion |
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