This is not your father’s FDA
Changes are afoot at the Food & Drug Administration that will affect nearly every medical device maker hoping to hit the U.S. market. The federal watchdog agency is looking to revamp the 510(k) clearance process, creating a new “Class IIb” category that will require some kind of clinical data.
That means choosing the right contract research organization is paramount. This webcast features Laurie Halloran, founder and CEO of Halloran Consulting, and her more than 20 years’ experience running clinical trials and managing CRO partners. Halloran reviews best practices to ensure quality and consistency in the oversight of the outsourced operational work; current trends in the clinical sphere; the “do’s & don’ts” of working with a CRO; and details the importance of assessing CRO performance and the proper transfer of compliance obligations.
The webcast also features John Lewis, vice president of public affairs for the Assn. of Clinical Research Organizations, with an informed and detailed look at the CRO landscape.
- Overview of clinical trials and medical devices
- Regulatory picture for clinical trials
- Overview of the CRO industry
- Planning a clinical trial
- Finding the right partner
- Conducting an effective trial
Do you know the difference between clinical data and a clinical trial? Is your company ready to meet the challenges of the new FDA? Download MassDevice.com’s “Choosing the right CRO” today and make sure you and your company are prepared.