is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, April 18th, 2012. For more details, or to register please visit our site at www.fxconferences.com
An investigator's brochure (IB) is required for compliance with the EU Medical Device Directives (e.g. 2.7.2) and also with ISO 14155: Clinical Investigations of Medical Devices in Human Subjects – Good Clinical Practices. The development of an IB for medical devices should reflect the engineering features of the device, in much the same way that an IB for pharmaceutical agents reflects the chemical features of the drug. As a dynamic document, the IB must be carefully constructed and, ideally, it should accurately represent the current state of all knowledge about the investigational product – including information about AEs, SAEs, and important manufacturing details as well as nonclinical and clinical study results.
This audio conference presentation provides an overview and best practices for the medical device IB, looking at some of the related issues specific to devices and discussing how the brochure is likely to evolve over time.
