Developing Safety Narratives for a CSR

Course
24 Lessons

Are you ready to master writing safety narratives? Introducing my mini-course on Developing Safety Narratives for a CSR!

In this program, I cover the art of crafting compelling safety narratives that will complement your CSR, covering both what to include in your safety narratives and the process for safety narrative development.

With my expert guidance, you'll learn how to structure safety narratives effectively using the available data, including where to pull the relevant information and how to lay out the content in a meaningful way. But I don't stop there – I also equip you with invaluable project management skills to execute large safety narrative projects with ease.

Whether you're a seasoned professional looking to refine your skills or a newcomer eager to master safety narrative writing, this mini-course has something for everyone. Don't miss this opportunity to become a safety narrative pro – enroll now and unlock your full potential!

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Introduction

Welcome.mp4

Course Objectives.mp4

Section 1: What is a Safety Narrative?

Defining the Safety Narrative.mp4

ICH E3.pdf

Section 2: Getting Started: Tools and Source Material

Tools for Safety Narrative Development Part 1.mp4

Walk-through of Example Safety Narrative Template.mp4

Safety Narrative Template.docx

Tools for Safety Narrative Development Part 2.mp4

Source Material for Safety Narratives.mp4

FDA-3500A.pdf

CIOMS Form.pdf

Section 3: Writing Effective Safety Narratives

Basics of Effective Writing.mp4

What to Include in a Safety Narrative.mp4

Example Completed CIOMS Form.pdf

Another Look at the Safety Narrative Template.mp4

Relationship of Safety Narratives to the CSR Body.mp4

Section 4: Process for Developing Safety Narratives

High-level Workflow.mp4

Document Kick-off.mp4

Authoring and Review Process.mp4

Document Finalization.mp4

Safety Narrative Timeline.mp4

Section 5: Safety Narratives in Practice

Execution of Large Safety Narrative Projects Part 1.mp4

Execution of Large Safety Narrative Projects Part 2.mp4

Summary

Final Tips for Success.mp4