This meeting will look at the regulatory environment for pre-filled syringes which are disposable syringes that contain a single dose of a medication for use by patients. Specifically, this 12th annual meeting will look new EU medical device regulations which require that marketing authorisation applications for medicines with an integral medical device must include the results of the device’s assessment of conformity by a notified body. This regulation covers pre-filled syringes as well as pens, transdermal drug delivery devices and pre-filled inhalers. The meeting will also discuss new post-market surveillance requirements.
