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.

From the programme

- 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

Eva Lilienberg, Kapitel Tre AB
Stefan Johnn, Kenvue
Elisabeth Augustsson, Restracom
Åsa Holmgren, Holmgren Regulatory Consulting AB
Marie Gårdmark, RegSmart Life Science AB
Anders Juréus, RegSmart Life Science AB
Åsa By, Macanda AB
Maria Nilsson Hagberg, RegFile AB

Elisabeth Widmark, RegFile AB
Joanne Betts, AstraZeneca
Sarah Illi, AstraZeneca
Joanna Applequist, Awa Sweden AB

Time and venue

The course is held online through live streaming on May 29-30 2024.
The course is also available on site in Stockholm. If you want to attend in person, please register here.

Participation fee

The registration fee is 9.900 SEK until April 15 2024 and thereafter 12.500 SEK. The fee includes digital documentation and certificate. 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.