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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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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PROGRAMME HIGHLIGHTSPrinciples 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

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

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)

Find out more here

The ECCRT Team +32 2 892 4000