Regulatory Strategies
10,900 kr
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 be available soon.
Time and venue
The course is held online through live streaming on May 27-28 2025.
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 10.900 SEK until April 15 2025 and thereafter 13.800 SEK. The fee includes digital documentation and certificate. All prices exclude VAT.
Coming events: Events in English
Date | Date | Event | Days | Location |
12 nov 2024 | nov 12 | 17th Symposium on Pharmacokinetics and Drug Metabolism Pepparedsleden 5 Mölndal | 2 | Pepparedsleden 5 Mölndal |
18 mar 2025 | mar 18 | 2nd Nordic Conference on Computational Chemistry Göteborg | 2 | Göteborg |
Details
Regulatory Strategies
Date: 2025-05-27
End date: 2025-05-28
No. of days: 2
Venue: Online
Town/City: Online
Participation fee
Price: 10900 SEK
Early registration
Price: 13800 SEK
Late registration
All prices are excl VAT.
Registration
Contact
Project administrator
Jenny Hagberg
Project manager
Sandra Trost
Kontakt
i Stockholm AB
Box 1136
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11
E-post: info@lakemedelsakademin.se
Org.nr: 556005-7043
Utbildningar
Kongresser/symposier
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