Date: 11 & 12 December 2019
Location: The Netherlands, Amsterdam
Language: English
Costs: Regular €
1350.-
Introduction
Qserve Medical Device CRO and Consultancy 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 2-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.
NEW! We will also take the opportunity to inform you and
discuss the key changes in the upcoming 2019 version of the standard.
Note: this training can also be provided in-house for
other organizations in the supply chain involved in one or more
stages of the life-cycle of a medical device, including design and development,
production, storage and distribution, installation, servicing or provision of
associated activities. The contents will be adapted to the specific role(s) of that
organization.
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.
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Program overview:
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Typical clinical investigation terminology and GCP
definitions
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Differences and similarities between ISO-14155 for
Medical devices, and other GCP standards (e.g. ICH-GCP)
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Key changes in the upcoming ISO 14155-2019
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Review and discuss the content of ISO 14155 (2011)
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Investigator-initiated studies: compliance and value
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Practical clinical investigation planning and
execution, including real-world examples
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Commonly seen pitfalls and how you can avoid them in
your trials
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Questionnaire and answers
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Who should
attend this course?
Clinical and regulatory personnel working at a medical
device manufacturer, who are involved in the preparation, execution or
evaluation of clinical investigations with medical devices.
Certification:
Personal GCP certificate.
Trainers: