Regulatory Medical Writing

All levels
21 lessons
3 quizzes
491 students


  • Strong desire to learn how to write Medical Regulatory documents
  • Previous experience in Regulatory/Medical field is a bonus


  • 200 LAI credits, 3 CECs
  • Duration: Theory 3 hours and Practice 6 hours.
  • Research Scientist Title
  • Academy membership
  • Postgraduate Certificate
  • Mobile Access
  • Downloadable handy resources
  • Full lifetime access
  • Language: English + English subtitles

Target audiences

  • Regulatory Affairs Specialists
  • Regulatory Affairs Officers
  • Medical Writers
  • Clinical Trial Specialists

Regulatory Medical Writing Postgraduate Course provides a possibility to learn strategies, tricks, action plans to become confident in collaboration within a clinical and regulatory environment to create accurate, clearly worded documents.

Unlock the power of effective Regulatory Medical Writing with our comprehensive course designed for professionals aspiring to excel in the field of regulatory documents and submissions. The Regulatory Medical Writing Course at our Academy provides a unique opportunity to delve deeply into the intricacies of regulatory writing, offering a blend of theoretical knowledge, hands-on practice, and real-world examples.

Key Highlights:

  • In-Depth Understanding: Gain a profound understanding of the regulatory landscape, guidelines, and requirements governing medical writing in clinical and nonclinical contexts.
  • Document Types and Structure: Explore various regulatory documents such as Investigator’s Brochures, Clinical Study Reports, and Common Technical Documents (CTD), understanding their structure, purpose, and the critical information they convey.
  • Writing Techniques and Best Practices: Hone your writing skills through practical sessions focused on developing clear, concise, and compliant regulatory documents. Learn industry best practices and techniques to effectively communicate complex scientific information.
  • Practical Examples and Case Studies: Dive into real-world examples and case studies, dissecting successful submissions and identifying key elements that contribute to their approval.
  • Actual Submission Documents: Gain exclusive access to actual submission documents, providing a hands-on experience in working with the materials encountered in regulatory processes.
  • Tips from Industry Experts: Learn from experienced professional in the field who will share insights, tips, and strategies to navigate the regulatory writing landscape successfully.
  • Career Development: Receive guidance on advancing your career in regulatory medical writing, exploring job opportunities, and understanding the evolving role of regulatory writers in the pharmaceutical and healthcare industries.
  • Practical Application: Apply your knowledge by working on your own regulatory writing projects, whether you are a beginner crafting your first document or an experienced professional seeking to refine your skills.
  • Networking Opportunities: Connect with fellow participants, industry experts, and potential employers through networking sessions, fostering a supportive community of regulatory medical writers.

This course is tailored for professionals at various career stages, including researchers, medical writers, regulatory affairs specialists, and professionals transitioning into regulatory medical writing. Whether you’re looking to enhance your skills, explore a new career path, or stay current with industry trends, our Regulatory Medical Writing Course provides the tools and knowledge needed for success in this critical and evolving field. Join us and embark on a journey to master the art of regulatory medical writing.

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Master of Science, Trinity College Dublin, UCC, UCD. Senior Medical writer for Amgen, CSL, ICON. For more than 18 years, serving as a personal coach and consultant for C-level leadership and management in therapeutical areas: diabetes, immunology, oncology. With a commitment to embracing innovative educational technologies, Devon has seamlessly transitioned into the role of Ladavius Academy Lecturer.

Yes, beside theory, practice and review of actual medical regulatory documents (e.g. Clinical Research Protocols, Investigator's Brochures templates, guidelines) is included.
Yes, written examples from actual studies, Do's and Dont's are covered within the scope of this course.
No, online courses are receiving the same level of accreditation and verification ID within Academy, as onsite programs.