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TORRENT DETAILS
Udemy - Regulatory Medical Writing Basics
TORRENT SUMMARY
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Language: English | Duration: 3h 8m | Size: 1.3 GB
Document development process, key regulatory documents, and tips and tools for success
What you'll learn
Understand the role of a regulatory medical writer
Have developed a medical writing toolkit for success
Be equipped with a proven process for document development, from kick-off to submission
Understand how to provide extraordinary value to your teams
Know what to ask of your clients/teams to ensure successful project execution
Have a basic understanding of the types of documents that regulatory medical writers develop
Better understand the content and development process for 3 key documents: protocols, investigator's brochures, and clinical study reports
Requirements
There are no prerequisites for taking this course.
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FILE LIST
Filename
Size
~Get Your Files Here !/1. Introduction/1. Welcome.mp4
14.3 MB
~Get Your Files Here !/1. Introduction/2. Breaking Down the Myths.mp4
35.4 MB
~Get Your Files Here !/1. Introduction/3. Course Objectives and Content.mp4
5.7 MB
~Get Your Files Here !/10. Summary and Wrap-Up/1. Daily Life as a Regulatory Medical Writer.mp4
16.8 MB
~Get Your Files Here !/10. Summary and Wrap-Up/2. Staying Up to Date as a Medical Writer and Final Tips for Success.mp4
12 MB
~Get Your Files Here !/2. The Role of Regulatory Medical Writers/1. The Who, What, Where, When, and Why of Medical Writing.mp4
31.2 MB
~Get Your Files Here !/3. Tools for Successful Document Development/1. Guidances, Templates, and Style Guides.mp4
23.6 MB
~Get Your Files Here !/3. Tools for Successful Document Development/1.1 ICH E3.pdf
249.7 KB
~Get Your Files Here !/3. Tools for Successful Document Development/1.2 ICH E6.pdf
689.3 KB
~Get Your Files Here !/3. Tools for Successful Document Development/1.3 M4.pdf
261.8 KB
~Get Your Files Here !/3. Tools for Successful Document Development/1.4 M4E(R2).pdf
470.3 KB
~Get Your Files Here !/3. Tools for Successful Document Development/1.5 M4S.pdf
115.5 KB
~Get Your Files Here !/3. Tools for Successful Document Development/2. Walk-Through of ICH E6 Guidance.mp4
82.8 MB
~Get Your Files Here !/3. Tools for Successful Document Development/3. The Value of Templates in Medical Writing.mp4
26.7 MB
~Get Your Files Here !/3. Tools for Successful Document Development/4. Walk-Through of the Transcelerate Protocol Template (Contents of a Template).mp4
71.5 MB
~Get Your Files Here !/3. Tools for Successful Document Development/4.1 CPT_CoreBWE-v009.docx
305.9 KB
~Get Your Files Here !/3. Tools for Successful Document Development/5. Style Guides The Medical Writer's Go-To Resource.mp4
12.9 MB
~Get Your Files Here !/3. Tools for Successful Document Development/6. Other Software and Tools for Success.mp4
31.3 MB
~Get Your Files Here !/4. Document Development Process/1. Steps for Developing a Regulatory Document - Part 1.mp4
22.2 MB
~Get Your Files Here !/4. Document Development Process/2. Steps for Developing a Regulatory Document - Part 2.mp4
55.9 MB
~Get Your Files Here !/4. Document Development Process/3. Walk-Through of Example Timeline.mp4
38.7 MB
~Get Your Files Here !/5. Becoming an Effective Medical Writer/1. Writing Effective Regulatory Documents.mp4
25.1 MB
~Get Your Files Here !/5. Becoming an Effective Medical Writer/2. Working Collaboratively to Develop Documents.mp4
22.2 MB
~Get Your Files Here !/5. Becoming an Effective Medical Writer/3. Tips for Moving Documents Through the Development Process.mp4
40.8 MB
~Get Your Files Here !/5. Becoming an Effective Medical Writer/3.1 Example document review notification email.pdf
134.4 KB
~Get Your Files Here !/5. Becoming an Effective Medical Writer/4. Challenges in Medical Writing.mp4
40.6 MB
~Get Your Files Here !/5. Becoming an Effective Medical Writer/5. How Medical Writers Add Value to Their Teams.mp4
15.8 MB
~Get Your Files Here !/6. Documentation in Drug Development/1. Types of Regulatory Documents and the Common Technical Document (CTD).mp4
38.1 MB
~Get Your Files Here !/6. Documentation in Drug Development/2. Regulatory Submissions and Applications.mp4
45.2 MB
~Get Your Files Here !/6. Documentation in Drug Development/3. Content of the CTD - Part 1.mp4
11.9 MB
~Get Your Files Here !/6. Documentation in Drug Development/4. Content of the CTD - Part 2.mp4
10.9 MB
~Get Your Files Here !/6. Documentation in Drug Development/5. Content of the CTD - Part 3.mp4
25.5 MB
~Get Your Files Here !/6. Documentation in Drug Development/6. Clinical Trial Documents and Other Regulatory Documentation.mp4
17.9 MB
~Get Your Files Here !/7. Clinical Trial Protocols/1. What is a Clinical Trial Protocol.mp4
29 MB
~Get Your Files Here !/7. Clinical Trial Protocols/2. Clinical Trial Design.mp4
16.2 MB
~Get Your Files Here !/7. Clinical Trial Protocols/3. Controls and Bias Elimination.mp4
20.4 MB
~Get Your Files Here !/7. Clinical Trial Protocols/4. Objectives, Endpoints, Population, and Assessments.mp4
31 MB
~Get Your Files Here !/7. Clinical Trial Protocols/5. Process for Protocol Development.mp4
20.5 MB
~Get Your Files Here !/7. Clinical Trial Protocols/6. Walk-Through of the Transcelerate Protocol Template (Sections of a Protocol).mp4
223.9 MB
~Get Your Files Here !/7. Clinical Trial Protocols/7. Protocol Tips and When to Amend.mp4
16.2 MB
~Get Your Files Here !/8. Investigator's Brochures/1. What is an Investigator's Brochure (IB).mp4
12.6 MB
~Get Your Files Here !/8. Investigator's Brochures/2. Content of an IB - Sections 1 through 5.mp4
28.3 MB
~Get Your Files Here !/8. Investigator's Brochures/3. Content of an IB - Sections 6 and 7.mp4
17.9 MB
~Get Your Files Here !/8. Investigator's Brochures/4. IB Tips and When to Update.mp4
16.2 MB
~Get Your Files Here !/9. Clinical Study Reports/1. What is a Clinical Study Report (CSR).mp4
21.8 MB
~Get Your Files Here !/9. Clinical Study Reports/1.1 CSR_CoreBWE-v004.docx
142.1 KB
~Get Your Files Here !/9. Clinical Study Reports/2. Non-Data vs Data Sections of a CSR.mp4
19.2 MB
~Get Your Files Here !/9. Clinical Study Reports/3. Other Components of a CSR Safety Narratives, CSR Synopsis, and Appendices.mp4
24.6 MB
~Get Your Files Here !/9. Clinical Study Reports/4. CSR Tips and Types.mp4
