DevCourseWeb com Udemy Regulatory Medical Writing Basics | CA35D3B5998211AFDFCBCD8E1A182555E32AC4EC

DevCourseWeb com Udemy Regulatory Medical Writing Basics

Name	[ DevCourseWeb.com ] Udemy - Regulatory Medical Writing Basics	DOWNLOAD Copy Link
Total Size	1.4 GB
Total Files	51
Last Seen	2024-07-23 00:15
Hash	CA35D3B5998211AFDFCBCD8E1A182555E32AC4EC

/
Get Bonus Downloads Here.url	0.2 KB
/1. Introduction/
1. Welcome.mp4	15.0 MB
2. Breaking Down the Myths.mp4	37.1 MB
3. Course Objectives and Content.mp4	6.0 MB
/.../10. Summary and Wrap-Up/
1. Daily Life as a Regulatory Medical Writer.mp4	17.6 MB
2. Staying Up to Date as a Medical Writer and Final Tips for Success.mp4	12.6 MB
/.../2. The Role of Regulatory Medical Writers/
1. The Who, What, Where, When, and Why of Medical Writing.mp4	32.8 MB
/.../3. Tools for Successful Document Development/
1. Guidances, Templates, and Style Guides.mp4	24.7 MB
1.1 ICH E3.pdf	255.7 KB
1.2 ICH E6.pdf	705.8 KB
1.3 M4.pdf	268.1 KB
1.4 M4E(R2).pdf	481.6 KB
1.5 M4S.pdf	118.3 KB
2. Walk-Through of ICH E6 Guidance.mp4	86.8 MB
3. The Value of Templates in Medical Writing.mp4	28.0 MB
4. Walk-Through of the Transcelerate Protocol Template (Contents of a Template).mp4	75.0 MB
4.1 CPT_CoreBWE-v009.docx	313.2 KB
5. Style Guides The Medical Writer's Go-To Resource.mp4	13.5 MB
6. Other Software and Tools for Success.mp4	32.8 MB
/.../4. Document Development Process/
1. Steps for Developing a Regulatory Document - Part 1.mp4	23.3 MB
2. Steps for Developing a Regulatory Document - Part 2.mp4	58.6 MB
3. Walk-Through of Example Timeline.mp4	40.6 MB
/.../5. Becoming an Effective Medical Writer/
1. Writing Effective Regulatory Documents.mp4	26.3 MB
2. Working Collaboratively to Develop Documents.mp4	23.3 MB
3. Tips for Moving Documents Through the Development Process.mp4	42.8 MB
3.1 Example document review notification email.pdf	137.6 KB
4. Challenges in Medical Writing.mp4	42.6 MB
5. How Medical Writers Add Value to Their Teams.mp4	16.6 MB
/.../6. Documentation in Drug Development/
1. Types of Regulatory Documents and the Common Technical Document (CTD).mp4	39.9 MB
2. Regulatory Submissions and Applications.mp4	47.4 MB
3. Content of the CTD - Part 1.mp4	12.5 MB
4. Content of the CTD - Part 2.mp4	11.4 MB
5. Content of the CTD - Part 3.mp4	26.8 MB
6. Clinical Trial Documents and Other Regulatory Documentation.mp4	18.8 MB
/.../7. Clinical Trial Protocols/
1. What is a Clinical Trial Protocol.mp4	30.4 MB
2. Clinical Trial Design.mp4	17.0 MB
3. Controls and Bias Elimination.mp4	21.4 MB
4. Objectives, Endpoints, Population, and Assessments.mp4	32.5 MB
5. Process for Protocol Development.mp4	21.5 MB
6. Walk-Through of the Transcelerate Protocol Template (Sections of a Protocol).mp4	234.8 MB
7. Protocol Tips and When to Amend.mp4	17.0 MB
/8. Investigator's Brochures/
1. What is an Investigator's Brochure (IB).mp4	13.2 MB
2. Content of an IB - Sections 1 through 5.mp4	29.7 MB
3. Content of an IB - Sections 6 and 7.mp4	18.8 MB
4. IB Tips and When to Update.mp4	17.0 MB
/.../9. Clinical Study Reports/
1. What is a Clinical Study Report (CSR).mp4	22.9 MB
1.1 CSR_CoreBWE-v004.docx	145.5 KB
2. Non-Data vs Data Sections of a CSR.mp4	20.1 MB
3. Other Components of a CSR Safety Narratives, CSR Synopsis, and Appendices.mp4	25.8 MB
4. CSR Tips and Types.mp4	23.2 MB
/~Get Your Files Here !/
Bonus Resources.txt	0.4 KB
Total files 51