Summary

This 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:

“Not knowing anything about Regulatory Affairs when the course started, I now have a very good overview of how it all works.”

“The course was very informative, well-organised, and I even had fun! It contained valuable background information and practicable experience. Thank you very much for a great course! I have no further comments; it was really almost perfect!"
Angela Rödel, Associate Global Regulatory Affaris, medac GmbH, Germany

“Professional and warm attitude from the course leader, Atrium staff and all speakers. Your passion for what you do was showing through the screen. That is inspiring! ”
Anna-Karin Lindqvist, PhD, Director Project Management, Camurus AB, Sweden

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