You need to update and refresh your knowledge on ICH-GCP, including the ICH-GCP E6 (R2) Addendum 2016 but you also want to further focus on the aspects that are relevant to your Regulatory department? Then this complementary eLearning course is designed for you.
How is this course different from usual refresher sessions? It is conducted in a very interactive way to review ICH-GCP through workshops, quizzes and within Regulatory Department real-life situations.
This eLearning course is designed for Regulatory professionals who already have knowledge of the International Council for Harmonisation and Good Clinical Practice (ICH-GCP) standards, but need to be up-to-date up to the items added in 2016. It is designed as a refresher on ICH-GCP and will cover the responsibilities of all Regulatory players on the clinical field. This refresher session, supported by the complementary module, is a very interactive course which will allow you to verify the extend of your knowledge on ICH-GCP and complete the potential gap.
Quizzes and exercises for self-assessment are included to provide a better understanding of each part of the course. You will be able to test your comprehension with a final grading assessment.
All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.
Course timeAt your own pace; the course will remain available online for you for 3 months after you register for it. ------------------------ Course Credits: 5 hours
Who should attend
Everyone who wants to refresh their knowledge of the current regulations and GCP in clinical studies, with a focus on the practical aspects that are relevant to Regulatory Affairs.
The complementary ICH-GCP Refresher for Regulatory Staff cannot be considered as a stand-alone course as its content is developed as a support to the ICH-GCP refresher course.
- General GCP-Refresher
- Definitions and Principles of GCP
- Responsibilities for all involved persons/parties
- The essential GCP-related documents and audit trail
- Changes by and impact of the 2016 GCP addendum for Investigators and for Sponsors
- GCP Audit Findings at the Investigator as well as at the sponsor & tips to help you avoid them
- GCP-Refresher focused on Regulatory Requirements
- Introduction to Regulatory Authorities
- Regulatory Requirements and the Principles of GCP /li>
- Regulatory defined responsibilities and documents
- Obligations for IRB/IEC, Investigator, Sponsor, Essential Documents, Protocol & Investigator’s Brochure
- Requirements in practice
Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.
- Refresh your knowledge on current GCP requirements
- Grasp what GCP implies for all clinical trial stakeholders
- Understand the essential documents of clinical studies
- Reflect on the implications of ICH-GCP with a focus on the responsibilities, activities and documents specifically for Regulatory requirements
- Obtain a clear view on the impact of all items added by the ICH-GCP E6 (R2) Addendum 2016
- Be prepared to implement all requirements in your regulatory activities
- Know how to avoid findings in case of audit and/or inspection
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (1)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (6)
- Study and Site Management (2)
- Data Management and Informatics (4)
- 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