Technical Writing for Regulatory Submissions – A Step-by-Step Approach
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Speaker : CHARLES H. PAUL
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When : Thursday, September 11, 2025
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Time : 01 : 00 PM EST
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Charles H. Paul is the President of CHP Consulting Llc – a regulatory,
training, and technical documentation consulting firm. Charles has been a
regulatory consultant for over 25 years and has published numerous
white papers on the subject. The firm works with both domestic and
international clients designing solutions for complex training and
documentation issues.
Technical writing for regulatory submissions is a critical skill in ensuring that documents meet regulatory requirements while maintaining clarity, accuracy, and coherence. This webinar, "Technical Writing for Regulatory Submissions – A Step-by-Step Approach," provides a structured method for crafting high-quality submissions that align with FDA, EMA, and other global regulatory expectations. Attendees will learn the essential components of regulatory writing, from understanding submission types and document structures to applying best practices in clarity, consistency, and compliance. Through a step-by-step approach, participants will gain insights into structuring documents effectively, eliminating ambiguity, and writing in a way that facilitates regulatory review and approval.
In addition to technical writing principles, this session will cover practical aspects such as document formatting, review processes, and common pitfalls that can lead to regulatory delays. The webinar will incorporate real-world examples, interactive exercises, and expert guidance to help participants refine their writing skills. Whether you are new to regulatory writing or seeking to enhance your existing expertise, this training will provide actionable strategies to improve the quality and impact of your submissions. Attendees will leave with a deeper understanding of how to write with clarity and precision, ensuring that their regulatory documents are not only compliant but also compelling and reviewer-friendly.
Areas Covered
I. Introduction
- Welcome and Objectives
- Importance of Technical Writing in Regulatory Submissions
o Why does clear, concise, and structured writing matter?
o Consequences of poor documentation - Overview of Regulatory Submissions
o Types of regulatory submissions (FDA, EMA, Health Canada, etc.)
o Key regulatory expectations for technical documentation
II. Step-by-Step Approach to Regulatory Writing
Step 1: Understanding the Regulatory Framework
- Overview of regulations and guidelines (FDA, EMA, ICH, ISO 13485)
- Essential documents in regulatory submissions
- Key considerations before writing (audience, purpose, and requirements)
Step 2: Structuring Your Document
- Common document structures (e.g., CTD format, IDE, 510(k), PMA)
- Logical flow: Headings, subheadings, and content organization
- Using templates and style guides
Step 3: Writing with Clarity and Precision
- Principles of clear and concise writing
- Avoiding ambiguity and unnecessary complexity
- Using plain language vs. technical jargon
- Writing for different audiences (scientists, regulators, reviewers)
Step 4: Ensuring Compliance and Consistency
- Importance of regulatory language
- Avoiding common compliance pitfalls
- Citing sources and justifying claims
- Adhering to company and regulatory style guides
Step 5: Reviewing and Editing Your Document
- The review process: self-review vs. peer review
- Tools and techniques for effective editing
- Ensuring accuracy, completeness, and readability
Step 6: Submission Best Practices
- Formatting and document control
- Managing multiple contributors and reviewers
- Final quality checks before submission
III. Q&A and Wrap-Up
- Open Q&A session
- Summary of key takeaways
- Resources and further learning opportunities
Who Should Attend
- Regulatory Affairs Specialists
- Regulatory Affairs Managers
- Medical Writers
- Technical Writers
- Quality Assurance Professionals
- Clinical Research Associates
- Clinical Trial Managers
- Compliance Officers
- Documentation Specialists
- Submission Specialists
- Regulatory Consultants
- Product Development Managers
- R&D Scientists and Engineers
- Medical Device and Pharmaceutical Professionals
- Regulatory Project Managers
Why Should You Attend
Participants should attend this webinar to gain a structured and practical approach to writing clear, concise, and compliant regulatory submissions. Whether they are regulatory professionals, technical writers, or subject matter experts contributing to submissions, this session will provide essential guidance on crafting documents that meet the expectations of regulatory agencies such as the FDA and EMA. By attending, they will learn how to improve document organization, enhance readability, and avoid common writing pitfalls that can delay approvals. With expert insights, real-world examples, and interactive exercises, attendees will leave with actionable strategies to elevate the quality of their submissions, ultimately increasing their chances of regulatory success.
Topic Background
Regulatory submissions are essential documents required for the approval of medical devices, pharmaceuticals, and other healthcare products, ensuring compliance with stringent global regulations. Agencies such as the FDA, EMA, and Health Canada have specific requirements for technical documentation, making clear and precise writing a critical skill for regulatory professionals. Poorly structured or ambiguous submissions can lead to delays, additional queries, or even rejection, highlighting the need for well-organized, compliant, and reviewer-friendly documentation. This webinar is designed to provide a step-by-step guide to technical writing for regulatory submissions, equipping participants with the knowledge and tools to create high-quality documents that facilitate efficient regulatory review and approval.
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$199.00
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