Essentials Series

Regulatory Affairs Essentials

The core submission types a regulatory affairs function manages, and how it works day to day with quality, manufacturing and CMC.

What this course covers

This course covers the core submission types a regulatory affairs function manages across a product's lifecycle, how regulatory affairs interacts with quality, manufacturing and CMC functions day to day, the relationship between a regulatory filing and the established conditions concept in ICH Q12, and how to work effectively with health authorities during review and post-approval.

Who this course is for

New regulatory affairs staff building foundational knowledge
Cross-functional staff who work with regulatory affairs without formal training in the function

What you'll learn

The core submission types a regulatory affairs function manages across a product's lifecycle
How regulatory affairs interacts with quality, manufacturing and CMC functions day to day
The relationship between a regulatory filing and the established conditions concept in ICH Q12
How to work effectively with health authorities during review and post-approval
Where regulatory affairs essentials connect to GMPify's dedicated CMC and change control courses

Why it matters

Regulatory affairs decisions touch nearly every other function in a pharmaceutical company, but staff outside the function often don't understand why a seemingly small manufacturing change can trigger a significant filing obligation. This course builds that shared understanding.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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