Date: Wednesday, June 18, 2025
Time: 11am ET
Solutions: Regulatory
Services: Regulatory Writing, Regulatory Operations
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.
Mastering Style Guides and Lexicons for Tailored Submissions
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.
Regulatory Services Manager, Document Quality, Certara
With more than eight years on Certara’s document quality team, Sarah Steffin specializes in document management support for regulatory submissions during all document development stages. She has created and managed style guide and submission-specific lexicons, showing medical writers and editors how efficiencies are gained with the use of these tools. By leveraging her experience with regulatory documents and submissions, Sarah demonstrates best practices that streamline processes, ensuring documents meet both client demands and regulatory requirements.
CEO & Founder, Intelligent Editing Ltd
Daniel Heuman is the CEO of Intelligent Editing and the creator of PerfectIt, a leading software tool for ensuring consistency and quality in medical writing. PerfectIt is used by 15 of the top 20 global pharmaceutical companies, helping thousands of writers maintain high standards. He has presented at numerous conferences, including AMWA and EMWA, on how technology and well-designed processes can reduce editorial headaches. Daniel also launched Draftsmith, an AI-enabled writing assistant, in December 2023.
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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.
