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

"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

"I would recommend this course to all my colleagues or friends who are new to the pharmaceutical industry - whether they are working directly in regulatory affairs or in another area."

Sophia Feilberg, Clinical Submission Coordinator, Lundbeck Pharma 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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