Regulatory Strategies

About the course

Are you ready to take your regulatory competence to the next level? This 2 day course is formed to give you the opportunity and tools to be able to contribute strategically to the company in your regulatory role – whether that is at a research or marketing company. The course is given in English.

Who should attend?

This course is recommended for senior Regulatory Affairs Managers who seek strategic competence. We recommend having knowledge or experience equivalent to Läkemedelsakademin’s Basics of Regulatory Affairs  at the least, to fully understand and benefit from the course.

Learning objectives

• Knowledge of the regulatory strategic and tactical considerations for the different phases of drug development, before and after product approval, on a global level, emphasising on Europe and US.
• Understanding of key concepts and considerations in regulatory strategies to be able to support drug development, ensure regulatory approval and optimize product label.
• Competence to contribute in building a regulatory strategy for a product and to provide regulatory support/advice during the different phases of drug development before and after product approval.

Course outline

• The Regulatory Affairs role – a strategic partner
• Global regulatory strategies, including case study
• Strategies for EU, US, Japan and China respectively, including case study
• Paediatrics
• Orphan drugs
• Patent and exclusivity – what is the difference?
• Fast track-procedures in the EU and US
• Authority consultation
• CMC strategies
• Health Technology Assessment
• Regulatory Intelligence
• Business intelligence
• The Regulatory Affairs role in a cross functional team