[ CoursePig.com ] Udemy - Clinical Trial Regulation EU 536 - 2014 in Clinical Research

File Name

Size

Get Bonus Downloads Here.url

179 B

~Get Your Files Here !/1. Introduction/1. Welcome and Objectives.mp4

77 MB

~Get Your Files Here !/1. Introduction/1.1 My Linked In Profile.html

103 B

~Get Your Files Here !/1. Introduction/2. Key Facts.mp4

21 MB

~Get Your Files Here !/1. Introduction/2.1 CTR 536 2014 - Overview of Chapters and Articles.pdf

109 kB

~Get Your Files Here !/1. Introduction/2.2 REGULATION 536 2014.pdf

757 kB

~Get Your Files Here !/1. Introduction/3. Why Changes.mp4

23 MB

~Get Your Files Here !/1. Introduction/4. Timeline for Introduction and Transition Period.mp4

28 MB

~Get Your Files Here !/1. Introduction/5. Definitions.mp4

60 MB

~Get Your Files Here !/1. Introduction/5.1 2017_06_28_recommendation_on_axmps.PDF

416 kB

~Get Your Files Here !/1. Introduction/6. What is EU CTR 5362014.html

208 B

~Get Your Files Here !/2. Initial Authorization Procedure/1. Submission.mp4

48 MB

~Get Your Files Here !/2. Initial Authorization Procedure/1.1 roles-permissions-matrix-summary-sponsors-workspace-ctis-training-programme-module-07_en.pdf

542 kB

~Get Your Files Here !/2. Initial Authorization Procedure/2. Validation and Assessment.mp4

32 MB

~Get Your Files Here !/2. Initial Authorization Procedure/3. Decision.mp4

22 MB

~Get Your Files Here !/2. Initial Authorization Procedure/4. Initial Authorization Procedure.html

208 B

~Get Your Files Here !/3. Submissions and Reporting during a Clinical Trial/1. Substantial Modification.mp4

35 MB

~Get Your Files Here !/3. Submissions and Reporting during a Clinical Trial/2. Addition of a Member State.mp4

21 MB

~Get Your Files Here !/3. Submissions and Reporting during a Clinical Trial/3. Safety and Other Reporting Obligations.mp4

19 MB

~Get Your Files Here !/3. Submissions and Reporting during a Clinical Trial/4. Public Disclosure of Data.mp4

14 MB

~Get Your Files Here !/3. Submissions and Reporting during a Clinical Trial/5. Submissions and Reporting during a Clinical Trial.html

208 B

~Get Your Files Here !/4. Risks and Challenges/1. Risks and Challenges.mp4

30 MB

~Get Your Files Here !/4. Risks and Challenges/2. Practical exercise Risk Assessment of a clinical trial with CTR 5362014.html

212 B

~Get Your Files Here !/5. Practical Guide to CTIS Training Material Catalogue/1. CTIS Training Material Catalogue.mp4

46 MB

~Get Your Files Here !/5. Practical Guide to CTIS Training Material Catalogue/1.1 ctis-training-materials-latest-updates_en September 2022.pdf

463 kB

~Get Your Files Here !/5. Practical Guide to CTIS Training Material Catalogue/1.2 Link to the EMA Modular Training Landing Page.html

217 B

~Get Your Files Here !/6. Frequently-Asked Questions and Answers/1. Frequently-Asked Questions and Answers.mp4

88 MB

~Get Your Files Here !/6. Frequently-Asked Questions and Answers/1.1 CTR 536 2014 - QandA Version 6.2 September2022.pdf

1.3 MB

~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

212 B

~Get Your Files Here !/8. Conclusion/1. Conclusion and Perspectives.mp4

8.7 MB

~Get Your Files Here !/Bonus Resources.txt

386 B