Foundational ICH-Good Clinical Practice (GCP) E6 (R2) Training
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About this course
Reasons to attend
Did you know that your clinical investigations need to comply with the Good Clinical Practice (GCP) guideline? This one-day course is crucial for any professional in the field of clinical research. It will provide you with all elements of the International Council on Harmonization Good Clinical Practice (ICH-GCP) guideline E6 (R2), as required by the majority of Regulatory Authorities.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been mutually recognised by TransCelerate BioPharma
Course schedule
- One Day face-to-face training: 09h00-17h00
Course Description
This course covers all eight chapters of the ICH-GCP in its current version and will cover the responsibilities of every stakeholder involved, as well as its implementation in practice.Without training on the ICH-GCP requirements, 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 GCP in clinical studies with pharmaceuticals.The complete and most recent version of the ICH-GCP is covered by this training, including the Addendum of 2016. All elements of the addendum, such as risk-based quality management and supervision will be presented. In addition, the implementation of GCP requirements is explained and illustrated using examples from practice.Programme highlight
- Clinical Research and Regulations
- ICH-GCP definitions and Principles
- ICH-GCP Responsibilities of Ethics Committees/ Investigators/ Sponsors/Monitors
- The Protocol, Investigator’s Brochure and other Essential Trial Documents
- The GCP-Addendum of 2016
- Common GCP non-compliance
Learning objectives
- Identify the GCP requirements for conduct and documentation of clinical studies
- Distinguish the responsibilities of all involved parties
- Determine the regulatory conditions imposed by GCP
- Detect common problems and obtain insight to avoid errors
Who should attend
Any professional within clinical research; investigator; monitor; study coordinator or other staff that need to gain foundational knowledge about and comply with the current GCP standard. No prior training or working experience in a GCP environment is required.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (3)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (8)
- Study and Site Management (2)
- Data Management and Informatics (5)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained.
Trainers
Milcah Kahkelam Bungwa
I now have a better understanding of the GCP guidelines, why it is needed and how it should be applied. The course was very interactive giving room for new ideas and hence a better learning opportunity.
Aline Bodanese Prates
Takeda
Interaction with trainer and trainees, sharing practices, experiences - The GCP course is crucial to my daily job. Any new feature, update, needs to be implemented as urgent as possible. The format of the course was very interactive and didactic.