Date: 13-16th of November 2023
Location: The Netherlands, Arnhem
Language: English
Costs: € 5700.- per person
Introduction
Qserve CRO offers you a hands-on GCP course that
supports your everyday clinical operations and quality issues. Our course is
set up especially for professionals in the medical device industry that work
on clinical trials, PMCF studies and investigator
initiate trials (IIT), on a regular basis.
During this 4-day course, the content of the ISO-14155
GCP standard for medical devices will be our guide.
During the
interactive sessions, we will discuss the practical implementation of the standard. The theory will be supported by real-life examples of difficulties and mistakes on
the one hand, but also practical and clever solutions that avoid unnecessary
bureaucratic burdens on the other hand. At the end of the day, you will go home
with knowledge, GCP skills and practical ideas to implement
directly within your organization, and you will receive your personal
GCP certificate.
Learning objectives
To understand the content and role of the ISO-14155
standard in clinical investigation
To be able to implement the standard in a practical
way during the preparation, execution and evaluation of clinical studies with
medical devices
To learn from real-life examples that we come across
in our everyday CRO and consultancy practice. Allowing you an exclusive look
behind the scenes of several example trials.
Focus points
- Patient
safety
- Data
quality
- Practical
approach
- Good
documentation practice
- Site
selection, communication and collaboration
- Clinical
strategy.
Program Overview:
Day 1: ISO 14155:2020 ( 6 hours)
Day 2: ISO 14155:2020 (6 hours)
Day 3: Auditing ( 6 hours)
Day 4: Clinical evaluation and the link to related documents (6 hours)
Certification:
Personal GCP certificate.
Trainers: