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Regulatory Affairs > Beginner
Introduction to Regulatory Affairs (RA)
A free introduction to regulatory affairs — how medicines move through global health authorities, what the eCTD submission structure looks like, and how AI is starting to support regulatory teams with document drafting and intelligence. A practical starting point before SafeMeds Academy's full AI in Regulatory Affairs course.
Free preview lessons available — try before you buy
What you'll learn
- Describe the role of regulatory affairs across the pharmaceutical product lifecycle
- Identify major global health authorities and the purpose of ICH harmonization
- Explain the eCTD structure (Modules 1-5) used in regulatory submissions
- Understand the basics of CMC oversight and labeling documents (CCDS
- USPI
- SmPC)
- Recognise where AI and automation are being introduced into regulatory submissions
Course content
Course Roadmap and Welcome to Regulatory Affairs
Global Health Authorities and the ICH Harmonization Process
The Pharmaceutical Lifecycle - from Lab Bench to Market Approval
Understanding the eCTD Structure - Modules 1 through 5
Requirements
- No prior experience required
- No software or account needed to watch the lessons
Description
A free introduction to regulatory affairs — how medicines move through global health authorities, what the eCTD submission structure looks like, and how AI is starting to support regulatory teams with document drafting and intelligence. A practical starting point before SafeMeds Academy's full AI in Regulatory Affairs course.
This course is designed for:
- Anyone curious about a career in regulatory affairs
- Life-science graduates exploring regulated healthcare career paths
- Professionals considering SafeMeds Academy's full AI in Regulatory Affairs course
Instructor
SafeMeds Academy
Life-science curriculum specialist
Practical training for pharma, biotech, CRO, regulatory, clinical, PV, market access, medical writing, data, and AI-enabled teams across the globe.
How to earn your certificate
- Watch the lessons. Each lesson is marked complete automatically once you have watched 90% of its video — there is no button to click.
- Reach 100%. When all 8 lessons are complete, the final quiz unlocks in your course player and dashboard.
- Pass the final quiz. 20 multiple-choice questions, 70% to pass (14/20), with unlimited retries.
- Get your certificate. It is issued to your account automatically, emailed to you, and verifiable online.