Clinical Trial Regulation EU 536 - 2014 in Clinical Research --> [ DevCourseWeb ]
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| Torrent Size : | 576.63 MB |
Clinical Trial Regulation EU 536 - 2014 in Clinical Research --> [ DevCourseWeb ]
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Torrent File Content (31 files)
[ CoursePig.com ] Udemy - Clinical Trial Regulation EU 536 - 2014 in Clinical Research
Get Bonus Downloads Here.url -
Get Bonus Downloads Here.url -
179 bytes
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1. Introduction/1. Welcome and Objectives.mp4 -
1. Introduction/1. Welcome and Objectives.mp4 -
76.8 MB
1. Introduction/1.1 My Linked In Profile.html -
103 bytes
1. Introduction/2. Key Facts.mp4 -
20.85 MB
1. Introduction/2.1 CTR 536 2014 - Overview of Chapters and Articles.pdf -
108.81 KB
1. Introduction/2.2 REGULATION 536 2014.pdf -
756.95 KB
1. Introduction/3. Why Changes.mp4 -
22.68 MB
1. Introduction/4. Timeline for Introduction and Transition Period.mp4 -
28.26 MB
1. Introduction/5. Definitions.mp4 -
60.48 MB
1. Introduction/5.1 2017_06_28_recommendation_on_axmps.PDF -
416.33 KB
1. Introduction/6. What is EU CTR 5362014.html -
208 bytes
2. Initial Authorization Procedure/1. Submission.mp4 -
48.14 MB
2. Initial Authorization Procedure/1.1 roles-permissions-matrix-summary-sponsors-workspace-ctis-training-programme-module-07_en.pdf -
541.51 KB
2. Initial Authorization Procedure/2. Validation and Assessment.mp4 -
31.84 MB
2. Initial Authorization Procedure/3. Decision.mp4 -
22.44 MB
2. Initial Authorization Procedure/4. Initial Authorization Procedure.html -
208 bytes
3. Submissions and Reporting during a Clinical Trial/1. Substantial Modification.mp4 -
34.91 MB
3. Submissions and Reporting during a Clinical Trial/2. Addition of a Member State.mp4 -
20.87 MB
3. Submissions and Reporting during a Clinical Trial/3. Safety and Other Reporting Obligations.mp4 -
18.93 MB
3. Submissions and Reporting during a Clinical Trial/4. Public Disclosure of Data.mp4 -
13.8 MB
3. Submissions and Reporting during a Clinical Trial/5. Submissions and Reporting during a Clinical Trial.html -
208 bytes
4. Risks and Challenges/1. Risks and Challenges.mp4 -
30.42 MB
4. Risks and Challenges/2. Practical exercise Risk Assessment of a clinical trial with CTR 5362014.html -
212 bytes
5. Practical Guide to CTIS Training Material Catalogue/1. CTIS Training Material Catalogue.mp4 -
45.73 MB
5. Practical Guide to CTIS Training Material Catalogue/1.1 ctis-training-materials-latest-updates_en September 2022.pdf -
462.8 KB
5. Practical Guide to CTIS Training Material Catalogue/1.2 Link to the EMA Modular Training Landing Page.html -
217 bytes
6. Frequently-Asked Questions and Answers/1. Frequently-Asked Questions and Answers.mp4 -
88.27 MB
6. Frequently-Asked Questions and Answers/1.1 CTR 536 2014 - QandA Version 6.2 September2022.pdf -
1.29 MB
7. Practical Exercise Planning a Submission in line with the EU CTR 5362014/1. Planning a submission of Clinical Trial under the Clinical Trial Regulation.html -
212 bytes
8. Conclusion/1. Conclusion and Perspectives.mp4 -
8.67 MB
Bonus Resources.txt -
386 bytes
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