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1.27 GB

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File	Size
Get Bonus Downloads Here.url	182.00 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	12.90 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	22.20 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	10.90 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	31.00 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	12.60 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	142.10 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	386.00 B

Description

[ DevCourseWeb.com ] Regulatory Medical Writing Basics

If You Need More Stuff, kindly Visit and Support Us -->> https://DevCourseWeb.com

Published 12/2023
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch
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.

If You Need More Stuff, kindly Visit and Support Us -->> https://CourseWikia.com

Get More Tutorials and Support Us -->> https://FreeCourseWeb.com

We upload these learning materials for the people from all over the world, who have the talent and motivation to sharpen their skills/ knowledge but do not have the financial support to afford the materials. If you like this content and if you are truly in a position that you can actually buy the materials, then Please, we repeat, Please, Support Authors. They Deserve it! Because always remember, without "Them", you and we won't be here having this conversation. Think about it! Peace...