Regulatory Medical Writing

Summary

This comprehensive two-day course is designed to elevate your medical writing skills and drive success in regulatory writing within both clinical and pharmacovigilance communication (e.g. investigator brochures (IBs), protocols, clinical study reports, clinical overview, development safety update reports (DSURs), periodic safety update reports (PSURs) and risk management plans (RMPs)).

The program has been carefully planned to cover a broad range of topics within the medical writing field and industry experts will guide you through the various agenda items.
The course starts with an overall introduction to the content of the documents and how they are interlinked. It will also include the regulatory review processes and what assessors focus on when reviewing the documents. Later we will discuss general competencies that are relevant for medical writers. Selected areas within this field encompass lean writing, getting your key messages to stand out clearly and directing your writing to right target audience. Additionally, you will learn how to best handle stakeholder interactions and manage your projects, so you ensure an efficient writing and review process. Lastly, we will also touch upon key features of the future of medical writing, namely the role of artificial intelligence (AI) and structured content.

This dynamic and interactive course will feature engaging class discussions, medical writing examples, and group exercises, allowing you to put theoretical concepts into real-world practice, empowering you to enhance your regulatory communication skills.

Keywords

• Clinical medical writing
• Pharmacovigilance medical writing
• Industry guidance and resources
• The regulatory reviewer
• Effective communication
• Artificial intelligence in medical writing