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 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.
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
- 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
Eva Lilienberg, Kapitel Tre
Stefan Johnn, Kenvue
Elisabeth Augustsson, Restracom
Åsa Holmgren, Holmgren Regulatory Consulting AB
Marie Gårdmark, Reg Smart Life Science AB
Lecturer to be confirmed, AstraZeneca
More lecturers will be announced later.
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.
The registration fee is 9.900 SEK until April 29 2024 and thereafter 10.100 SEK. The fee includes digital documentation and certificate. All prices exclude VAT.
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.
Coming events: Events in English
|4th Swedish Medicinal Chemistry Symposium
|Trends in Metabolic Studies of Pharmaceutical Drugs
|17th Symposium on Pharmacokinetics and Drug Metabolism
End date: 2024-05-30
No. of days: 2
Price: 9900 SEK
Price: 10100 SEK
All prices are excl VAT.
i Stockholm AB
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11