Introduction to Regulatory Affairs - Copenhagen

Introduction to the Role of Regulatory Affairs in Pharma

This two-day course provides a comprehensive introduction to the broad field of regulatory affairs.

As a participant you will learn about the regulatory framework that governs pharmaceutical products across their entire life cycle – from early development and clinical trials to marketing authorization and post-approval changes.

The course highlights the role of regulatory affairs as key in bridging science, quality, compliance, market access and patient safety

Key Regulatory Topics You Will Learn - Regulatory frameworks with emphasis on EU

• Marketing Authorization Applications (MAA) and procedures
• Non-clinical and clinical documentation requirements
• Pharmaceutical quality, specifications, and dossiers
• Regulatory strategies and intelligence
• Life Cycle Management and variations

This course is for you who work in or around pharmaceutical development

This course is designed for engineers, scientists, and professionals working in the pharmaceutical industry, a regulatory setting or a consulting firm

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.

Learning outcomes: What you gain from the Regulatory Affairs course

After participating in this course, you will:

• Understand the role and scope of regulatory affairs in pharmaceutical development and commercializationGain knowledge of EU and international regulatory frameworksBe able to navigate documentation requirementsHave acquired insights into regulatory strategies and life cycle management
• Collaborate better with regulatory professionals and ensure compliance in your projects

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.

Course Programme: 2 Days of Structured Regulatory TrainingDay 1 – Regulatory Foundations

• Welcome and introduction
• Introduction to Regulatory Affairs and its role in pharma and product labelling
• EU legislation and marketing authorization procedures
• Overview of US, Japan, WHO and ICH guidelines (CTD)
• Regulatory strategies and intelligence
• Pharmaceutical quality requirements for drug substance and drug product
• IMPD structure for clinical trials and biologics

Day 2 – Development & Life Cycle Management

• Special regulatory procedures (scientific advice, orphan drugs, advanced therapies, expedited pathways)
• Non-clinical documentation basics
• Clinical studies: proof of concept, confirmatory phases, endpoints & data requirements
• Clinical Trial Applications, benefit-risk assessment, pharmacovigilance & real-world evidence
• Life Cycle Management: variations, safety, and quality updates
• Market access considerations and dossier management
• Wrap-up and Q&A

Please note: This course can be delivered in either Danish or English depending on the participants. However, all course materials are provided in English.

Practical Information About the CourseBefore the course:

Reading materials will be provided in advance. No mandatory preparation.

During the course:

Duration: 2 days, 9:00–16:00.

Lunch and refreshments included.

The course is structured in an informal classroom setting with plenty of opportunities to ask questions. 

After the course:

Participants receive a certificate of completion

Instructor:

Jesper Kihl

Jesper has over 40 years of experience in Life Science, including leading Global Regulatory Affairs at LEO Pharma for 14 years and holding multiple roles across manufacturing, quality, development, logistics, sales and regulatory at Novo Nordisk.

He now advises life science and medtech start-ups, collaborates with universities and funds, and lectures at IDA.