[ DevCourseWeb.com ] Udemy - Regulatory Medical Writing Basics

File Name

Size

Get Bonus Downloads Here.url

182 B

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

14 MB

~Get Your Files Here !/1. Introduction/2. Breaking Down the Myths.mp4

35 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

17 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 MB

~Get Your Files Here !/3. Tools for Successful Document Development/1. Guidances, Templates, and Style Guides.mp4

24 MB

~Get Your Files Here !/3. Tools for Successful Document Development/1.1 ICH E3.pdf

250 kB

~Get Your Files Here !/3. Tools for Successful Document Development/1.2 ICH E6.pdf

689 kB

~Get Your Files Here !/3. Tools for Successful Document Development/1.3 M4.pdf

262 kB

~Get Your Files Here !/3. Tools for Successful Document Development/1.4 M4E(R2).pdf

470 kB

~Get Your Files Here !/3. Tools for Successful Document Development/1.5 M4S.pdf

116 kB

~Get Your Files Here !/3. Tools for Successful Document Development/2. Walk-Through of ICH E6 Guidance.mp4

83 MB

~Get Your Files Here !/3. Tools for Successful Document Development/3. The Value of Templates in Medical Writing.mp4

27 MB

~Get Your Files Here !/3. Tools for Successful Document Development/4. Walk-Through of the Transcelerate Protocol Template (Contents of a Template).mp4

72 MB

~Get Your Files Here !/3. Tools for Successful Document Development/4.1 CPT_CoreBWE-v009.docx

306 kB

~Get Your Files Here !/3. Tools for Successful Document Development/5. Style Guides The Medical Writer's Go-To Resource.mp4

13 MB

~Get Your Files Here !/3. Tools for Successful Document Development/6. Other Software and Tools for Success.mp4

31 MB

~Get Your Files Here !/4. Document Development Process/1. Steps for Developing a Regulatory Document - Part 1.mp4

22 MB

~Get Your Files Here !/4. Document Development Process/2. Steps for Developing a Regulatory Document - Part 2.mp4

56 MB

~Get Your Files Here !/4. Document Development Process/3. Walk-Through of Example Timeline.mp4

39 MB

~Get Your Files Here !/5. Becoming an Effective Medical Writer/1. Writing Effective Regulatory Documents.mp4

25 MB

~Get Your Files Here !/5. Becoming an Effective Medical Writer/2. Working Collaboratively to Develop Documents.mp4

22 MB

~Get Your Files Here !/5. Becoming an Effective Medical Writer/3. Tips for Moving Documents Through the Development Process.mp4

41 MB

~Get Your Files Here !/5. Becoming an Effective Medical Writer/3.1 Example document review notification email.pdf

134 kB

~Get Your Files Here !/5. Becoming an Effective Medical Writer/4. Challenges in Medical Writing.mp4

41 MB

~Get Your Files Here !/5. Becoming an Effective Medical Writer/5. How Medical Writers Add Value to Their Teams.mp4

16 MB

~Get Your Files Here !/6. Documentation in Drug Development/1. Types of Regulatory Documents and the Common Technical Document (CTD).mp4

38 MB

~Get Your Files Here !/6. Documentation in Drug Development/2. Regulatory Submissions and Applications.mp4

45 MB

~Get Your Files Here !/6. Documentation in Drug Development/3. Content of the CTD - Part 1.mp4

12 MB

~Get Your Files Here !/6. Documentation in Drug Development/4. Content of the CTD - Part 2.mp4

11 MB

~Get Your Files Here !/6. Documentation in Drug Development/5. Content of the CTD - Part 3.mp4

26 MB

~Get Your Files Here !/6. Documentation in Drug Development/6. Clinical Trial Documents and Other Regulatory Documentation.mp4

18 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 MB

~Get Your Files Here !/7. Clinical Trial Protocols/3. Controls and Bias Elimination.mp4

20 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 MB

~Get Your Files Here !/7. Clinical Trial Protocols/6. Walk-Through of the Transcelerate Protocol Template (Sections of a Protocol).mp4

224 MB

~Get Your Files Here !/7. Clinical Trial Protocols/7. Protocol Tips and When to Amend.mp4

16 MB

~Get Your Files Here !/8. Investigator's Brochures/1. What is an Investigator's Brochure (IB).mp4

13 MB

~Get Your Files Here !/8. Investigator's Brochures/2. Content of an IB - Sections 1 through 5.mp4

28 MB

~Get Your Files Here !/8. Investigator's Brochures/3. Content of an IB - Sections 6 and 7.mp4

18 MB

~Get Your Files Here !/8. Investigator's Brochures/4. IB Tips and When to Update.mp4

16 MB

~Get Your Files Here !/9. Clinical Study Reports/1. What is a Clinical Study Report (CSR).mp4

22 MB

~Get Your Files Here !/9. Clinical Study Reports/1.1 CSR_CoreBWE-v004.docx

142 kB

~Get Your Files Here !/9. Clinical Study Reports/2. Non-Data vs Data Sections of a CSR.mp4

19 MB

~Get Your Files Here !/9. Clinical Study Reports/3. Other Components of a CSR Safety Narratives, CSR Synopsis, and Appendices.mp4

25 MB

~Get Your Files Here !/9. Clinical Study Reports/4. CSR Tips and Types.mp4

22 MB

~Get Your Files Here !/Bonus Resources.txt

386 B