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D-TARGET 2007 Autumn Session Courses
Clinical Investigations and Regulatory
Training for Medical Devices
Dates: September 10 - 14, 2007
Venue: D-TARGET Headquarters, Montagny-près-Yverdon,
Switzerland
See
here for registration details
Don't miss this terrific opportunity to increase your
knowledge and advance your skills by participating in
the D-TARGET 2007 Autumn Session Courses. With five
distinctively in-depth courses to choose from, you'll
explore the methods that take you around daily obstacles
and discover what it takes to get the job done right
in today's fast-paced CRO industry.
Program:
Monday, September 10 - Wednesday, September 12
BASIC
MONITORING COURSE
FOR MEDICAL DEVICE CLINICAL INVESTIGATIONS
This 2½ day GCP certification program focuses
on monitoring of medical device investigations and
takes into account the appropriate regulatory requirements
as well as device specific approaches to greatly increase
monitor efficiency and sucess.
Tuesday,
September 11
MEDICAL
DEVICE TRIALS -
HOW TO COMPLY WITH THE REGULATIONS
In-depth review of EU regulations, including an update
of European national requirements, Ethics Committee,
overview of the ISO 14155, data protection requirements
and vigilance reporting for clinical investigations
are provided in this 1-day course.
Wednesday,
September 12
CRITICAL
LITERATURE REVIEW
Participants will learn to implement critical literature
review in their clinical strategy and use the appropriate
processes as successful tools to CE mark. And how
to distinguish when to use the critical literature
review route vs./or in combination with a prospective
clinical investigation. ½ day course.
Wednesday,
September 12
POST
MARKET SURVEILLANCE PROCESS
FOR MEDICAL DEVICES IN THE EU
Review of the regulatory requirements in Europe for
vigilance and post market surveillance, including
a practical approach on how to setup a system to comply
with the regulations for your specific product are
provided in this ½ day course session.
Thursday,
September 13 - Friday, September 14
PROJECT
MANAGEMENT FOR MEDICAL DEVICE
CLINICAL INVESTIGATIONS IN EUROPE
This 1½ day course provides practical and innovative
information and tools which will allow you to quickly
set up and manage your clinical investigation, tracking
and budgeting concerns with the highest quality and
quickest timelines.
See
here for registration details
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