Regulatory Affairs Essentials – Video Course for Career Starters

Build a solid foundation in Regulatory Affairs and understand why regulation matters, what regulatory professionals actually do, and how products are developed and authorised in Europe.

Who This Course Is For

• Graduates and young professionals exploring a first role in Regulatory Affairs.
  Career changers from R&D, Quality, Clinical, Regulatory Operations, or related fields.
  Anyone who wants to document structured Regulatory knowledge with a certificate on their CV and LinkedIn profile.

Learning Outcomes

After completing this 3:28h video course, you will be able to:

• Explain why regulation is essential for patient, consumer, and environmental protection and how it shapes innovation.
• Describe the day‑to‑day activities of Regulatory Affairs professionals across the product lifecycle.
• Outline the main stages of product development and how Regulatory Affairs contributes at each step.
• Identify key EU regulatory agencies and understand their roles in assessment, authorisation, and supervision.
• Understand how dossiers are structured, which formats are used, and what “Good Regulatory Practice” means in everyday work.
• Navigate the EU regulatory framework and find relevant laws and guidelines online.
• Explain the basics of EU marketing authorisation for new medicinal products and the concept of variations (post‑approval changes).

What You Get

• 3:28 hours of on‑demand video content, divided into focused chapters.
• Knowledge checks (“Test”) and answer reviews to consolidate learning.
• Practical case studies that connect theory with real Regulatory day‑to‑day work.
• Certificate of completion to document your skills.

Course Structure (Overview)

Chapter 1 – Introduction to Regulatory Affairs

• Why regulation exists and how it protects patients, consumers, and the environment.
• What regulatory professionals do: core tasks, interfaces, and impact on the product lifecycle.
• How product development works: from idea and early development to market launch and maintenance.
• Key activities of the Regulatory Affairs function in development, submission, and post‑marketing.
• Regulatory agencies in Europe: overview of EMA and national competent authorities.
• Test + answer discussion to check your understanding.

Chapter 2 – Regulatory Frameworks and Dossiers

• Dossiers: types, structure, and common formats used for marketing authorisation.​
• Principles of Good Regulatory Practice and how they translate into daily tasks.[
• The EU regulatory framework: how EU, EEA, and national rules interact.
• How to find laws, guidelines, and official documents on the internet (e.g. EMA, EC, national agencies).
• Short profiles of key regulations and guidelines relevant for beginners.
• Test + answers to reinforce the concepts.

Chapter 3 – Marketing Authorisation and Lifecycle Management

• How to register a new medicinal product in the EU: high‑level process and main routes.
• Variations (post‑approval changes): what they are and why they are critical for lifecycle management.
• Other activities at the stewardship stage: renewals, safety‑related updates, and ongoing compliance.
• Test + answers to apply your knowledge.

Format & Process

• 100% online video course (3:28h), accessible on demand from your computer or tablet.
• Purchase in CHF or EUR via our shop; you receive an invoice by email.
• After payment, you receive personal access to all videos and materials.
• Option to combine this video course with live Q&A or coaching sessions as an upgrade.

For Companies and Organisations

The content of this video course can be integrated into customised in‑house training programmes and combined with live workshops and case discussions for your Regulatory, R&D, or Quality teams.