Clinical
and Regulatory Training Courses
D-TARGET offers the most comprehensive
clinical and regulatory training courses available
today. All courses are conducted either on-site or
at D-TARGET
facilities in Switzerland by highly experienced medical
device professionals and can be tailored to meet any
specific needs.
For
information on booking D-TARGET training courses,
please contact
us.
Training courses:
BASIC
MONITORING COURSE
FOR MEDICAL DEVICE CLINICAL INVESTIGATIONS
Course
duration: 2½ days
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.
MEDICAL
DEVICE TRIALS -
HOW TO COMPLY WITH THE REGULATIONS
Course
duration: 1 day
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.
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.
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.
VIGILANCE
REQUIREMENTS IN THE EU
Course duration: ½ day
Review
of the regulatory requirements in Europe for post
market surveillance and vigilance including practical
approach of how to setup a system to comply with the
regulations for your specific product are provided
in a half day course session.
Efficient
data capturing is essential during clinical investigations.
Too often we see that Case Report Forms do not collect
the right data or are designed in a way that makes
data analysis inefficient or even impossible. Efficient
CRF design ensures better compliance from the investigator,
increases monitor's and data management personnel's
efficiency leading to an overall saving in time and
money! This one-day course reviews the requirements
of overall CRF design, practical examples of do's
and don'ts, and also reviews the data flow and how
to ensure full traceability.
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.
For
information on booking D-TARGET training courses,
please contact
us.
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