Regulatory Affairs: Getting a Medicine to Market in the EU and UK

Wishlist Share

About Course

Understand how medicines are developed, authorised and maintained in the EU and UK, from clinical trial approval and dossier preparation to variations and lifecycle management.

Who it’s for

Scientists leaving the lab, life-science graduates, QA and clinical professionals moving into regulatory affairs, and start-up teams who need to understand the route to market.

What you’ll be able to do

  • Explain the roles of the EMA, the European Commission, national agencies and the MHRA
  • Map regulatory milestones across drug development, including clinical trial authorisation
  • Choose between centralised, decentralised, mutual recognition and national routes
  • Describe current UK routes, including the International Recognition Procedure
  • Navigate the structure of the CTD and eCTD (Modules 1 to 5)
  • Explain key quality (CMC) and product information requirements
  • Manage variations, renewals and other lifecycle obligations

What’s included

  • 9 in-depth modules, each with a structured lesson
  • 9 module quizzes to check your understanding
  • Worked examples and a practical exercise in every module
  • About 50 hours of study, at your own pace
  • Lifetime access, on any device
  • Certificate of completion

How you study

Each module combines a structured lesson with a worked example, a practical exercise and key takeaways, followed by a short quiz. You need 70% to pass each quiz and can retake it as often as you like. Complete every module to finish the course.

Show More

What Will You Learn?

  • Explain the roles of the EMA, the European Commission, national agencies and the MHRA
  • Map regulatory milestones across drug development, including clinical trial authorisation
  • Choose between centralised, decentralised, mutual recognition and national routes
  • Describe current UK routes, including the International Recognition Procedure
  • Navigate the structure of the CTD and eCTD (Modules 1 to 5)
  • Explain key quality (CMC) and product information requirements
  • Manage variations, renewals and other lifecycle obligations

Course Content

The regulatory landscape
Who regulates medicines in the EU and UK and what RA does

  • The regulatory landscape
  • Module check: The regulatory landscape

Drug development and regulatory milestones
From the lab to the clinic: trials, advice and special designations

EU marketing authorisation routes and legal bases
Centralised, decentralised, mutual recognition and national procedures

UK routes to market
MHRA national routes, recognition and UK-wide licensing

The CTD and eCTD dossier
How a marketing authorisation dossier is structured

Quality (CMC) requirements
What regulators expect in Module 3

Product information and labelling
SmPC, patient leaflet, labels and readability testing

Lifecycle management: variations and renewals
Keeping a licence up to date after approval

Regulatory strategy and your RA career
Planning submissions, working with agencies and building a career