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
Tailored Project - Belgium
“I would really like to thank ECCRT for the very high quality ICH GCP training which was given by Mr. Gerald Van Roey in June 2011.
All the attendees were VERY enthusiastic afterwards !!!! It is clear that ECCRT really stands for high quality”
Aurora De Ponti
I'm very enthusiastic about the course I have attended. Marleen Verbeeck explained everyting in a clear way, giving several helpful examples. There was always the possibility to ask questions or to share our experience. It's a great opportunity not only to learn about ICH-GCP but also to create important proffessional connections
Lambda Plus
I participated on the “ICH-Good Clinical Practice” training on September 2016. I was really impressed by the teacher knowledge. She has a deep experience of Good Clinical Practice and she was able to communicate it with enthusiasm. I asked several questions. All of them were answered with details and real life examples. I also appreciated the fact that the manual is very clear and the course was very interactive.
Karen Roels
Janssen Pharma
The trainers were highly qualified and motivated which made the course personal and interactive. As a junior in the clinical research sector, this course gave me the perfect basis to start!
Eric Dooms
Military Hospital Queen Astrid
Interaction with other actors ( bio, pharma, Med,..) made the course a very positive experience
Lynn Neulinger
Bracco
Excellent trainer, very knowledgeable and interactive. Good slides and training material, excellent balance between theory and exercices.
Anja Hijzen
Janssen Pharmaceutica
A really good one-day course which gives you all you need to know, really to the point and useable right away. - Great teacher! The course was very interactive and I was a bit scared to be bored but I was not.
Alexia Chrysostomou
This course gives you the highlights of GCP and is a great starting base for someone who doesn't have previous experience. The trainer thoroughly explained the course material. The workshops were a great way of understanding the theory. And the trainer answered all the questions in a very comprehensive manner.
Jorge Martinez
Breast International Group (BIG)-aisbl
Everything I learned in this course will be taking into account regarding my work with clinical trials - Teacher is excellent and course content is very useful for all those who deal with Clinical Trials - Great teacher keeps students motivated and allowed questions and analysis of real day by day examples
Barbara Hoegy
Takeda
I had previously worked in a GCP environment, but for some years wasn't active in this field. I now feel more secure and comfortable with the upcoming tasks at Takeda - I really liked the interactive sessions with the questions
Christophe Golenvaux
Lambda Plus
Good refresher and global awareness on GCP update - Exchange with trainer about practical cases applied to theory - Although GCP might be perceived as a difficult matter thanks to workshops and interactive discussions the overall awareness is increased - A big thank to Marleen... and to Benedikt!
Peggy De Leenheer
Good knowledge of GCP and the basics of application - Good examples and interactive exercises during the course - Very professional and to the point.
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.