SGS is sponsoring the Regulatory Affairs Professionals Society (RAPS) annual conference, October 26 – 30 in Seattle, USA.
SGS is sponsoring RAPS 2012 (booth 231) and will be speaking at the EU Regulatory Essentials, Medical Devices & IVDs workshop and the EU Medical Devices Directive educational session.
Workshop: “EU Regulatory Essentials, Medical Devices & IVDs” (SOLD OUT*)
Friday October 26, 9am – 5pm
This workshop will provide a comprehensive overview of the essentials of EU regulatory affairs for a range of products including medical devices, pharmaceuticals and biologics. It will cover regulations, policies and requirements affecting Europe's regulatory system including specific issues and information addressing: advanced therapies, clinical trials, marketing applications, pre- and post-marketing requirements, classification, conformity assessment, and technical documentation. It will benefit anyone who is new to the regulatory profession, changing product line/industry, or preparing for the RAC EU examination.
EU Regulatory Essentials, Medical Devices & IVDs is sold out, but you can still access all the content online with the session library version.
Educational Session: “EU Medical Devices Directive”
Monday October 29, 1:15 – 2:45pm | Room 615
Europe is gearing up for significant legislative reform. Medical devices and active implants will be joined in one EU-wide regulation, whereas IVDs will constitute a second regulation. The new system will build on the existing system, strengthening it further in areas of oversight, transparency and rigor. While awaiting the reformed legislation, Europe is rapidly working to get key elements into the implementation of the current legal framework, such as enhanced focus on vigilance, on clinical trial coordination, Member State market surveillance and Notified Body (unannounced) audits and product testing. This educational session will help participants understand and discuss the state of play in EU legal reforms, describe the impact of PIP and other cases in the news on current legislation implementation, and prepare participants for the interim measures that are in place in 2012 after the PIP fraud case.
Talk directly with SGS at RAPS 2012
Learn more on any of these topics, and others, by visiting SGS healthcare, pharmaceutical and medical device experts at booth 231.