KURSUS
Regulatory Affairs in Practice
Pharma is a regulated industry. Gain a solid introduction to regulatory affairs – from EU legislation and international procedures to documentation requirements and life cycle management.
Kursusdetaljer
København
24. november 2026
Varighed: 1 dag
5.500,00 - 6.000,00 kr.
Priser er ekskl. moms
Engelsk
About the course
This intensive one-day course provides a comprehensive introduction to regulatory affairs in the pharmaceutical and life science industries. You will gain a structured overview of the regulatory frameworks governing the development, approval, and lifecycle management of medicinal products. The course covers European regulations as well as key global perspectives, enabling you to understand how regulatory requirements shape decisions across the entire value chain.
Regulatory affairs play a central role in ensuring product quality, patient safety, and market access. Understanding these requirements is essential when working in development, production, quality, or clinical functions. This course is designed to give you a practical and cross-functional understanding, allowing you to interact more effectively with regulatory specialists and contribute to better decision-making.
This course is for you who work in or around pharmaceutical development
This course is aimed at engineers, scientists and specialists working in pharma, biotech or medical device industries who need a fundamental understanding of regulatory affairs. It is particularly relevant if you work in development, manufacturing, quality, clinical operations, or project management and want to understand how regulatory requirements influence your work.
It is particularly relevant if you are:
- New to regulatory affairs or need a structured introduction.
- Working in R&D, production, project management or QC/QA roles
- Supporting or collaborating with regulatory functions and need to understand how regulatory requirements influence product development and commercialization
- Medical Consultants
Moreover, anyone who wish to understand how regulatory requirements shape the development and commercialization of medicines, can benefit from the course.
Your learning outcomes
- Understand the role of regulatory affairs in pharma and its impact on the full product lifecycle
- Gain insight into EU regulatory frameworks and approval procedures for medicinal products
- Learn the basics of global regulatory systems (FDA, Japan, ICH and WHO)
- Understand the structure and purpose of the Common Technical Document (CTD)
- Gain insight into regulatory strategy and regulatory intelligence
- Understand the requirements for quality, non-clinical and clinical documentation
- Learn the fundamentals of pharmacovigilance and benefit–risk considerations
- Understand lifecycle management principles, including variations and maintenance
Benefits for Your Organization
Your organization will gain an employee who:
- Understands regulatory expectations and compliance requirements
- Supports accurate documentation and streamlined regulatory submissions
- Helps reduce regulatory risk during development and post-approval phases
- Contributes to efficient project execution and timely market access
A foundational understanding of regulatory affairs strengthens interdisciplinary collaboration and supports sustainable product development.
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Katharina Laungaard
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