It’s a regulatory requirement to have regular GCP training. It’s important to have a refresher on the requirements everyone should be familiar with, but it’s also important to keep up to date with changes to the requirements. Our GCP Update course does exactly this and is revised every time we deliver it to ensure we cover the latest updates.
We also tailor the course to meet your specific requirements, for example for specific job roles or types of organisation. We can also cover requirements for Advanced Therapy Medicinal Products (ATMPs/ATIMPs) if appropriate.
Who is it suitable for?
This course is suitable for those who need a refresher and update on GCP for clinical trials, for example Clinical Operations Grouops, Medical Advisors, CRAs, CTAs, Clinical Project Managers, Investigators, Research Nurses, Study Site Co-ordinators, Ethics Committee members.
Objectives:
To provide delegates with an understanding of:
- The regulatory framework governing clinical trials in the relevant region(s)
- Changes in regulatory requirements in the last 12 months.
- Implication of changes on clinical trial conduct
Training Methods:
Delivery of the course consists of a combination of presentations by the trainer, group discussion and case studies. This course is also supported by additional resources available from our website.
Duration:
This course is usually delivered as a one day classroom session, but can be tailored to fit requirements.
Example Content:
ICH GCP Introduction / Refresher and Update
- ICH E6(R2) Refresher
- ICH E6 the future – proposed changes and implications
- ICH E8 update
EU Regulatory Environment refresher and update
- Eudralex Volume 10 overview
- New EU Regulation on Clinical Trials (536/2014)
- New EU Clinical Trials Guidelines
UK Clinical Research refresher and update
- Update on HRA approval
- Brexit latest
US Clinical Research refresher and update
- Key requirements of relevant 21CFR Legislation
- 21CFR part 11
- 21CFR part 50
- 21CFR part 54
- 21CFR part 56
- 21CFR part 312
- Update on FDA Guidances
Please contact me for more information and to organise your course.
Click here to sign up to our mailing list.