Course Overview

Regulatory Affairs (RA) ensures medicines are developed, approved, and maintained in compliance with strict requirements so they can reach patients safely and effectively. For those new to RA—or professionals in marketing, commercial, clinical, or manufacturing who work alongside regulatory affairs —it can seem complex and daunting.

This short, live online course will give you a clear and accessible introduction to the fundamentals of Regulatory Affairs in both the EU/UK and the US (FDA). In just 4 hours, you will understand what RA professionals do, how approval systems work, and how regulatory decisions impact wider business functions.

By the end of the course, you will have the knowledge and confidence to engage more effectively with regulatory colleagues and to explore RA as a career path.

Learn more about how we deliver live online training

Key Learning Objectives

• Explain the purpose of Regulatory Affairs and its role across the product lifecycle
• Identify the key EU, UK, and US regulatory authorities (EMA, EC, CMDh, MHRA, FDA) and their responsibilities
• Compare EU and US authorisation pathways (Centralised, DCP/MRP, NDA, BLA, etc.)
• Understand the basics of the CTD, CTAs vs INDs, and where beginners typically contribute
• Recognise the essentials of labelling: EU SmPC/PIL vs FDA Prescribing Information
• Describe lifecycle activities including variations, renewals, and US supplemental applications
• Appreciate how RA interacts with other functions such as Marketing, Clinical, CMC, and QA
• Locate and use key regulatory resources from EMA, MHRA, and FDA
• Apply your knowledge through a simple case study on choosing an approval route and mapping an RA plan

Who Should Attend?

This beginner-level course is designed for anyone who needs a clear, accessible introduction to Regulatory Affairs:

• Newcomers to Regulatory Affairs – graduates, trainees, or professionals recently starting in an RA role who need to understand the fundamentals.
• Aspiring Regulatory Professionals – individuals considering a career in Regulatory Affairs and looking for an overview of the field.
• Colleagues working with RA teams – professionals in Marketing, Commercial, Clinical, CMC, Quality or Project Management who collaborate with Regulatory Affairs and want to understand how regulations impact their work.
• Support staff and administrators – those who provide operational or project support and need context for the documents, processes, and terminology they encounter.

No prior regulatory knowledge is required — the course is pitched at beginner level and focuses on the essentials.

Format, Dates & Times

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

12 February 2026

1-Day Live Online Training
Register at the top of the page.

2 July 2026

1-Day Live Online Training
Register at the top of the page.

On-Demand Access

Can’t wait for the next course date?

Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.

Course Times

For live online delivery, the course starts at 10:00 AM (UK time) and finishes at 3:00 PM (UK time).

Group Discount

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

For more information, complete our contact form by following the link. Get in touch.