Program Overview
This deep-domain program takes regulatory, medical, and scientific writing professionals through the complete lifecycle of drug development — from bench research to patient-facing labelling. Participants will explore how documents evolve across nonclinical, clinical, regulatory, and commercial stages, with a focus on regulatory frameworks, CTD structures, ICH guidelines, and global submission strategies. Real-world case studies, reverse-engineering of labels, and mock authoring exercises illustrate how evidence is translated into regulatory claims and label statements. Designed and delivered by an expert with 25+ years’ experience, the course bridges scientific rigor and regulatory clarity, equipping participants to write purpose-driven, compliant documents that directly influence drug approval and market success.
Features
- Map the document flow from discovery through submission to labelling.
- Apply ICH, GCP, and CTD guidelines to regulatory writing.
- Translate scientific data into regulatory claims and label content.
- Handle regulatory interactions, query responses, and cross-functional alignment effectively.
Target audiences
- Regulatory writers
- Medical Writers & Medical Affairs Professionals
- Scientific writers
- Early-phase regulatory strategists
Curriculum
- 8 Sections
- 28 Lessons
- 3 Days
- Drug Discovery to First-in-Human (FIH)4
- Clinical Development Phases4
- Regulatory Submissions (IND/NDA/MAA)4
- Scientific Communications vs Regulatory Documents3
- Labelling – The Final Frontier4
- Health Authority Interactions3
- Case Studies and Real-World Examples3
- Hands-on Simulation and Assessment3
Instructor
