This training covers the key requirements in the relevant parts of 21 CFR: Parts 11, 50, 54, 56 and 312. We look at the forms required by FDA: 1572, Financial Disclosure etc.
We can also cover the history and structure of FDA and the specifics of FDA inspections.
We can also consider the implications of conducting IND trials outside the US – the key differences between EU and US regulation and what that means in practice.
Who is it suitable for?
This course is suitable for those who need an understanding of GCP requirements for clinical trials in the US.
To provide delegates with an understanding of:
- The regulatory framework governing clinical trials in the US
- An overview of the GCP requirements in the US.
- A summary of the key differences between EU and US GCP requirements
Delivery of the course will consist of a combination of presentations by the trainer, group discussion and case studies. This course will also be supported by additional resources available from our website.
Overview of FDA and its departments
Overview of Code of Federal Regulations Title 21
- Relevant regulations for Clinical Research
- 21 CFR part 11
- 21 CFR part 50
- 21 CFR part 54
- 21 CFR part 56
- 21 CFR part 312
- FDA Guidelines relating to Clinical Research
- Additional US requirements for Gene Therapy Clinical Trials
When and how CFR applies in Europe
Key differences between US and ROW requirements
- FDA forms
- Issues with Ethics Approvals
- FDA Inspections
FDA Rules for Acceptance of Foreign Data
Please contact me for more information and to organise your course.
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