In Europe, a clinical evaluation is always required
The 2007 amendment to the European Medical Device Directive comes into force in March 2010, and it requires a full clinical evaluation (CE) to be conducted as part of the process to market a device. Since notified bodies will review the results of the evaluation, it is important that the clinical evaluation is conducted appropriately, correctly and robustly. The clinical evaluation determines whether or not a new clinical investigation is required.
Clinical Device Group recently wrote a whitepaper on clinical evaluation reports, you may have a free copy at CE Report.
GHTF and a case study
The Global Harmonization Task Force--an international association of medical device regulators--published a document which explains how to do a clinical evaluation that will conform to the new MDD requirement. The document includes:
[x] Data from literature searching
[x] Data from clinical experience (including complaints)
[x] Data from clinical investigations
In this enjoyable and practical e-conference, we will use a case study to demonstrate how to conduct a step-by-step clinical evaluation according to the GHTF Clinical Evaluations document. We will use the guidance documents available and a flowchart of the process.
You will learn to understand the basics of conducting a clinical evaluation and what to put into the final report of the clinical evaluation.
By applying this information, you will create better clinical evaluations that are accepted by the Notified Bodies. Your will learn the depth and breadth that is expected in a CE report--how much is enough, how much is too much. Your clinical evaluation will stand up to the scrutiny and review of the notified body, and it may determine whether a clinical investigation needs to be conducted.
You will receive
[x] PowerPoint slides.
[x] An expert and experienced speaker.
[x] Chance for Q&A.
[x] Flowchart of process.
[x] Applicable guidance documents.
[x] CEUs and certificate of attendance.
Who should attend
[x] Regulatory professionals who liaise with Notified Bodies.
[x] People who craft clinical evaluation reports.
[x] People who craft US Reports of Prior Investigations.
[x] Clinical research professionals.
[x] Regulatory professionals.
[x] Clinical research functional managers.
[x] Managers who sign-off on clinical trials.
Janette Benaddi is the CEO of Medvance, Ltd. The company provides clinical research and regulatory consulting services to medical device, pharmaceutical and healthcare industries. She has written over 50 clinical evaluation reports on everything from Class III devices to Class I devices. She has over 18 years experience of managing pre- and post-market clinical studies in both devices and pharmaceuticals. Prior to founding Medvance almost 12 years ago, Janette worked in Paris for a medical device consultancy group as Project Director in Clinical/Regulatory Affairs. Janette has also worked with several multinational organizations in various clinical, regulatory and marketing roles.
Janette is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction, a Diploma in Management studies and also holds a teaching certificate. She is Chair of the Institute of Clinical Research and has published several articles and sits on a number of committees involved in the regulation and standardization of medical device studies. Ms. Benaddi can be reached at firstname.lastname@example.org.
The purchase is $423 for OnDemand access and $473 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.