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~Get Your Files Here !/1. Introduction/1. Welcome and Objectives.mp4
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~Get Your Files Here !/1. Introduction/1.1 My Linked In Profile.html
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~Get Your Files Here !/1. Introduction/2. Key Facts.mp4
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~Get Your Files Here !/1. Introduction/2.1 CTR 536 2014 - Overview of Chapters and Articles.pdf
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~Get Your Files Here !/1. Introduction/2.2 REGULATION 536 2014.pdf
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~Get Your Files Here !/1. Introduction/3. Why Changes.mp4
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~Get Your Files Here !/1. Introduction/4. Timeline for Introduction and Transition Period.mp4
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~Get Your Files Here !/1. Introduction/5. Definitions.mp4
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~Get Your Files Here !/1. Introduction/5.1 2017_06_28_recommendation_on_axmps.PDF
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~Get Your Files Here !/1. Introduction/6. What is EU CTR 5362014.html
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~Get Your Files Here !/2. Initial Authorization Procedure/1. Submission.mp4
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~Get Your Files Here !/2. Initial Authorization Procedure/1.1 roles-permissions-matrix-summary-sponsors-workspace-ctis-training-programme-module-07_en.pdf
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~Get Your Files Here !/2. Initial Authorization Procedure/2. Validation and Assessment.mp4
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~Get Your Files Here !/2. Initial Authorization Procedure/3. Decision.mp4
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~Get Your Files Here !/2. Initial Authorization Procedure/4. Initial Authorization Procedure.html
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~Get Your Files Here !/3. Submissions and Reporting during a Clinical Trial/1. Substantial Modification.mp4
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~Get Your Files Here !/3. Submissions and Reporting during a Clinical Trial/2. Addition of a Member State.mp4
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~Get Your Files Here !/3. Submissions and Reporting during a Clinical Trial/3. Safety and Other Reporting Obligations.mp4
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~Get Your Files Here !/3. Submissions and Reporting during a Clinical Trial/4. Public Disclosure of Data.mp4
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~Get Your Files Here !/3. Submissions and Reporting during a Clinical Trial/5. Submissions and Reporting during a Clinical Trial.html
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~Get Your Files Here !/4. Risks and Challenges/1. Risks and Challenges.mp4
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~Get Your Files Here !/4. Risks and Challenges/2. Practical exercise Risk Assessment of a clinical trial with CTR 5362014.html
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~Get Your Files Here !/5. Practical Guide to CTIS Training Material Catalogue/1. CTIS Training Material Catalogue.mp4
45.73MB
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~Get Your Files Here !/5. Practical Guide to CTIS Training Material Catalogue/1.1 ctis-training-materials-latest-updates_en September 2022.pdf
462.8KB
~Get Your Files Here !/5. Practical Guide to CTIS Training Material Catalogue/1.2 Link to the EMA Modular Training Landing Page.html
217B
~Get Your Files Here !/6. Frequently-Asked Questions and Answers/1. Frequently-Asked Questions and Answers.mp4
88.27MB
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~Get Your Files Here !/6. Frequently-Asked Questions and Answers/1.1 CTR 536 2014 - QandA Version 6.2 September2022.pdf
1.29MB
~Get Your Files Here !/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
212B
~Get Your Files Here !/8. Conclusion/1. Conclusion and Perspectives.mp4
8.67MB
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~Get Your Files Here !/Bonus Resources.txt
386B
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