EU Clinical Trials Regulation 536/2014

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Course content

Uncategorized
- Presentation
1 - CTR Overview
2 - Authorization procedure and assessment for a clinical trial
3 - Authorization procedure for a substantial modification of a clinical trial
4 - Authorization procedure for the addition of another members state concerned
5 - Protection of subjects and informed consent
6 - Start, end, temporary halt, and early termination of a clinical trial
- Start, end, temporary halt, and early termination of a clinical trial
- Key findings
- Quiz - 6 10 xp
7 - Safety reporting
8 - Conduct of a clinical trial
9 - Manufacturing and import of investigation medicinal products and auxiliary medicinal products
- Authorisation of manufacturing and import
- Responsibilities of the Qualified Person (QP)
- Key findings
- Quiz - 9 10 xp
10 - Labelling
- Investigational and auxiliary medicinal products
11- Sponsor and investigator
- Sponsor and co-sponsorship
- Sponsor and co-sponsorship
- Principal investigator
- Legal representative of the sponsor in the Union
- Key findings
- Quiz - 11 10 xp
12 - Damage compensation
- Damage compensation
Conclusion
Final Certification
- EU CTR 536/2014 - Certification

Completed