Regulatory Strategies

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.

For whom?

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.

• 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
  

Lecturers

Will soon be available.

Time and venue

The course is held May 27-28 2025 at Apotekarsocieteten, Wallingatan 26A in Stockholm.
The course is also available as an online live-streaming course. Those who choose to attend online will have access to all streamed lectures for 1 month after the course date. To register to the online course, please follow the link here.

Participation fee

The registration fee is 10.900 SEK until April 15 2024 and thereafter 13.800 SEK. The fee includes digital documentation and certificate, lunch and coffee/refreshments. Printed documentation can be obtained for an extra cost of 950 SEK. All prices exclude VAT.

Other information

In order for us to offer all our participants the best possible quality, please register your application no later than 72 hours before the start of the activity. At short notice, please contact the project administrator for the activity via email. For information such as cancellation policy, participant list, GDPR etc – see “Registration Terms” to the right.