It can be challenging to ensure standard language is used when writing regulatory and medical documents, especially when every agency and customer has their own rules. This session explores how to establish and apply consistent style conventions and how to harness technology to automate style guides and lexicons. This session is structured in two parts to address those challenges:
- The Foundation: Style Guides and Lexicons: Explore why styles guides and lexicons are indispensable for document quality and learn how to adapt them as a standard for every document that the team writes
- Working Faster: Enforcing Style Conventions Through Automation: Certara will outline and teach how to gain efficiencies in document development through technological tools like PerfectIt that are widely used among medical writers.
What you’ll learn:
- Recognize the value of style guides and lexicons as a foundation for customized writing frameworks.
- Apply best practices for style guides/lexicons and how efficiencies are gained by their use.
- Use technology to efficiently deploy and update custom style guides and word lists.
Speakers:
- Sarah Steffin, Regulatory Services Manager, Document Quality, Certara
- Daniel Heuman, CEO & Founder, Intelligent Editing Ltd
Real Questions Answered During the Webinar:
Q: “How frequently should my style guide be updated, considering FDA may release new guidances and recommendations after my style guide is rolled out?”
A: “I recommend doing a review of your style guide once a year to assess if updates are required based on internal feedback from your teams or updated guidance released by regulatory authorities.”
Q: “What are some of the biggest challenges regulatory writers face when implementing a new lexicon across global teams, and how do you recommend overcoming inconsistencies?”
A: “Automation is the key. Every writer has their own style, but when you’re collaborating on a single document, consistency is crucial. Embedding the lexicon in a tool like PerfectIt helps ensure the entire team is aligned from the start.”
