ICH-Good Clinical Practice (GCP) is the guideline ruling all clinical research including its conduct, performance, monitoring and the reporting of results. This course focuses on the GCP requirements in clinical studies with pharmaceuticals, taking into account the integrated addendum presented in February 2017. You will learn about the responsibilities of investigators, sponsors and monitors as well as the importance of essential documents. This course meets the criteria for ICH GCP Training of Investigator Site Personnel and all other clinical research professionals.

1. The course will allow professionals who are active in clinical research
to understand the responsibilities of everyone involved, with
practical examples for direct implementation in their area of work.
02 Oct 2017. Munich Germany.
ICH-Good Clinical Practice Training (GCP)
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2. ICH-Good Clinical Practice Training (GCP)
Without training on the International Conference on Harmonization
Good Clinical Practice (ICH-GCP) standards, or without experience in
clinical research, professionals are not always aware of the legal
regulations that govern clinical studies, including post-marketing trials.
ICH-GCP is the guideline ruling all clinical research including its
conduct, performance, monitoring and reporting of the results. This
course focuses on the requirements of Good Clinical Practice (GCP) in
clinical studies with pharmaceuticals. The complete and most recent
version of the ICH-GCP is covered by this training. In addition, the
implementation of GCP requirements is explained and illustrated using
examples from practice.
Our ICH-GCP training meets the Minimum Criteria for ICH GCP
Investigator Site Personnel Training Identified by TransCelerate
BioPharma as necessary to enable mutual recognition of GCP training
among trial sponsors.
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3. PROGRAMME HIGHLIGHTS
Principles of GCP
Responsibilities for all involved persons
Current legal regulations
The essential GCP-related documents
The most common problems &
practical tips to help you avoid them
LEARNING OBJECTIVES
✓Comprehending the basics of GCP requirements in clinical
research and how they are implemented
✓Understand the current legal requirements and GCP
responsibilities
✓To understand the essential documents of clinical studies

4. Barbara has been working in clinical operations for 12 years. She
is able to provide valuable practical, real life, advice in all areas of
clinical study management and GCP. Coming from a CRA
background and with CRO and sponsor experience she can shed
light on all aspects of clinical operations. Her particular focus is
on the creation of systems in clinical operations, and to enable
her clients to adhere to the standards.
Training and compliance are her new adventures that she feels
very excited about. In her spare time she roams the fields and
mountains of Europe on a historical or photographical mission.
All her courses take place in beautiful Munich, in southern
Germany.
Course instructor Barbara Gastl

5. OTHER COURSES BARBARA TEACHES
Clinical Research Training for Junior CRAs
Clinical Research Training for Senior CRAs
Clinical Project Management
Clinical Research Training for
Clinical Trial assistants (CTAs)

6. Find out more here
The ECCRT Team
+32 2 892 4000