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Workshop Syllabus

Congratulations for taking the first step in learning how GenAI can greatly improve your medical writing workflow. Our team will be in touch soon with more details, but in the meantime, check out the course syllabus below. 

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Workshop Syllabus

  1. Introduction (10 minutes) 

    1. Welcome and introduction to the workshop

      • Brief team introduction

    2. Overview of the workshop objectives and goals

  2. Regulatory Medical Writing for Clinical Trials (30 minutes) 

    1. Overview of regulatory medical writing for clinical trials

      • Regulatory medical writing function in pharma - not just writing clinical protocols 

      • Importance of regulatory medical writing as a core function in pharma

    2. Best practices for regulatory medical writing

      • Key elements of effective regulatory medical writing

      • Following best practices

    3. Common challenges in regulatory medical writing

      • Common challenges faced by regulatory medical writers

      • How do we overcome these challenges

  3. GenAI/LLM Tooling for Regulatory Medical Writing (690 minutes) 

    1. Introduction to GenAI/LLM tooling

      • What is GenAI/LLM ?

      • Features and capabilities of GenAI/LLM 

      • Where are we seeing life science (broadly) start to incorporate GenAI

    2. How can we use GenAI/LLM tooling for regulatory medical writing

      • Some use cases and examples

      • Benefits of using GenAI/LLM tooling for regulatory medical writing

    3. Best practices for using GenAI/LLM tooling

      • Key best practices for using GenAI/LLM tooling for regulatory medical writing

      • Why do these best practices matter for you? 

  4. Live Demo (30 minutes) 

    1. Interactive demo using ChatGPT that shows use of GenAI/LLM tooling in developing patient narratives

  5. Workshop (90 min)

    1. What are your current MW pain points where new tools like GenAI can help? Discuss and prioritize top 5 (30 min)

    2. What are realistic goals for us in bringing Gen AI into our org wihtin 3 months? 6 months? 12 months? Where do we want to be as an organization? (15 min)

    3. What are the barriers today for us to implement Gen AI solutions? Identify top 3 (30 min)

    4. What are the next steps we’ll commit to take as an organization? Owners and timelines (15 min)

  6. Conclusion (15 minutes) 

    1. Summary of the workshop

      • Key points covered in the workshop

      • The benefits of using GenAI/LLM tooling for regulatory medical writing

    2. Key takeaways and learnings

      • Highlight the key takeaways and learnings from the workshop

      • Workshop participants share their own takeaways and learnings

  7. Final Q&A session and follow up actions ​​

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