[ DevCourseWeb Com ] Udemy - Regulatory Medical Writing Basics
File List
| File | Size |
|---|---|
| Get Bonus Downloads Here.url | 182 B |
| ~Get Your Files Here !/1. Introduction/1. Welcome.mp4 | 14.29 MB |
| ~Get Your Files Here !/1. Introduction/2. Breaking Down the Myths.mp4 | 35.37 MB |
| ~Get Your Files Here !/1. Introduction/3. Course Objectives and Content.mp4 | 5.69 MB |
| ~Get Your Files Here !/10. Summary and Wrap-Up/1. Daily Life as a Regulatory Medical Writer.mp4 | 16.82 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 | 11.98 MB |
| ~Get Your Files Here !/2. The Role of Regulatory Medical Writers/1. The Who, What, Where, When, and Why of Medical Writing.mp4 | 31.24 MB |
| ~Get Your Files Here !/3. Tools for Successful Document Development/1. Guidances, Templates, and Style Guides.mp4 | 23.59 MB |
| ~Get Your Files Here !/3. Tools for Successful Document Development/1.1 ICH E3.pdf | 249.72 KB |
| ~Get Your Files Here !/3. Tools for Successful Document Development/1.2 ICH E6.pdf | 689.25 KB |
| ~Get Your Files Here !/3. Tools for Successful Document Development/1.3 M4.pdf | 261.85 KB |
| ~Get Your Files Here !/3. Tools for Successful Document Development/1.4 M4E(R2).pdf | 470.31 KB |
| ~Get Your Files Here !/3. Tools for Successful Document Development/1.5 M4S.pdf | 115.51 KB |
| ~Get Your Files Here !/3. Tools for Successful Document Development/2. Walk-Through of ICH E6 Guidance.mp4 | 82.76 MB |
| ~Get Your Files Here !/3. Tools for Successful Document Development/3. The Value of Templates in Medical Writing.mp4 | 26.75 MB |
| ~Get Your Files Here !/3. Tools for Successful Document Development/4. Walk-Through of the Transcelerate Protocol Template (Contents of a Template).mp4 | 71.53 MB |
| ~Get Your Files Here !/3. Tools for Successful Document Development/4.1 CPT_CoreBWE-v009.docx | 305.89 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 | 31.28 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 | 55.88 MB |
| ~Get Your Files Here !/4. Document Development Process/3. Walk-Through of Example Timeline.mp4 | 38.69 MB |
| ~Get Your Files Here !/5. Becoming an Effective Medical Writer/1. Writing Effective Regulatory Documents.mp4 | 25.11 MB |
| ~Get Your Files Here !/5. Becoming an Effective Medical Writer/2. Working Collaboratively to Develop Documents.mp4 | 22.21 MB |
| ~Get Your Files Here !/5. Becoming an Effective Medical Writer/3. Tips for Moving Documents Through the Development Process.mp4 | 40.81 MB |
| ~Get Your Files Here !/5. Becoming an Effective Medical Writer/3.1 Example document review notification email.pdf | 134.42 KB |
| ~Get Your Files Here !/5. Becoming an Effective Medical Writer/4. Challenges in Medical Writing.mp4 | 40.63 MB |
| ~Get Your Files Here !/5. Becoming an Effective Medical Writer/5. How Medical Writers Add Value to Their Teams.mp4 | 15.83 MB |
| ~Get Your Files Here !/6. Documentation in Drug Development/1. Types of Regulatory Documents and the Common Technical Document (CTD).mp4 | 38.09 MB |
| ~Get Your Files Here !/6. Documentation in Drug Development/2. Regulatory Submissions and Applications.mp4 | 45.24 MB |
| ~Get Your Files Here !/6. Documentation in Drug Development/3. Content of the CTD - Part 1.mp4 | 11.91 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 | 25.54 MB |
| ~Get Your Files Here !/6. Documentation in Drug Development/6. Clinical Trial Documents and Other Regulatory Documentation.mp4 | 17.94 MB |
| ~Get Your Files Here !/7. Clinical Trial Protocols/1. What is a Clinical Trial Protocol.mp4 | 28.97 MB |
| ~Get Your Files Here !/7. Clinical Trial Protocols/2. Clinical Trial Design.mp4 | 16.18 MB |
| ~Get Your Files Here !/7. Clinical Trial Protocols/3. Controls and Bias Elimination.mp4 | 20.38 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 | 20.48 MB |
| ~Get Your Files Here !/7. Clinical Trial Protocols/6. Walk-Through of the Transcelerate Protocol Template (Sections of a Protocol).mp4 | 223.89 MB |
| ~Get Your Files Here !/7. Clinical Trial Protocols/7. Protocol Tips and When to Amend.mp4 | 16.23 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 | 28.34 MB |
| ~Get Your Files Here !/8. Investigator's Brochures/3. Content of an IB - Sections 6 and 7.mp4 | 17.89 MB |
| ~Get Your Files Here !/8. Investigator's Brochures/4. IB Tips and When to Update.mp4 | 16.19 MB |
| ~Get Your Files Here !/9. Clinical Study Reports/1. What is a Clinical Study Report (CSR).mp4 | 21.85 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 | 19.21 MB |
| ~Get Your Files Here !/9. Clinical Study Reports/3. Other Components of a CSR Safety Narratives, CSR Synopsis, and Appendices.mp4 | 24.63 MB |
| ~Get Your Files Here !/9. Clinical Study Reports/4. CSR Tips and Types.mp4 | 22.16 MB |
| ~Get Your Files Here !/Bonus Resources.txt | 386 B |
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