Introduction to Regulatory Affairs

Summary

This two day course will give you a thorough introduction to the many tasks of a regulatory affairs department throughout the product life cycle of a pharmaceutical product — from early clinical trials and submission of a marketing authorization application to the life cycle management activities. You will learn about the EU procedures for obtaining marketing authorizations for pharmaceutical products, the documentation required in support of an application and many other tasks of a regulatory affairs department as well as the regulatory legislation.

Our course will focus on the European Union (EU) and give a brief introduction to the regulatory framework in the US.

Other course participants say

"The course provided a comprehensive overview with a good level of details to introduce Regulatory Affairs and also useful practical guidance. Good speakers."

Anna-Karin Lindqvist, PhD, Director Project Management

"I gained a lot of context to my current taks and a holistic insight to Regulatory overall."

Rasmus Ploug Winchler Larsen, Senior Manager, RA CMC Products, Leo Pharma A/S

"As someone new in the field, I think the course provided a good overview. It was well-structured, and I got a great outcome in terms of knowledge of Regulatory Affairs and the different tasks and procedures involved. I liked that the course consisted of both lectures, case-work and quizzes."

Associate Global Regulatory Affairs Manager

"Skilled speakers with practical experience, Illustrations of real-world scenarios made the topics tangible, despite the course's high academic level."

Kirsten Berger, Global Labeling Strategy Lead, Swedish Orphan Biovitrum

"The course is informative, well-structured, and gives a good basic knowledge."

Stine Kiær Larsen, RA CMC Specialist, Novo Nordisk A/S

"The course provides great overall knowledge of the work within Regulatory Affairs and why this field is important."

Allan Jensen, Senior User Communication Developer, Novo Nordisk A/S

Keywords

• Regulatory Affairs
• EU Legal Framework for Medicinal Products
• Documentation and Registration
• Maintenance of a Marketing Authorization
• Clinical Trials
• eCTD
• Product Information
• Pharmacovigilance
• Quality
• Drug Registration in the US
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