Basics of Regulatory Affairs
Are you looking for broad and essential knowledge of Regulatory Affairs? Our popular 3-day course gives you a comprehensive picture and is a platform for your further development in the area.
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Chemical-Pharmaceutical Documentation
The course gives an overview of the quality content (Module 3) of the Common Technical Documents (CTD) structure and the different quality granules for small molecule drugs, as well as a highlight of the most important differences from biologics.
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Regulatory documentation, content and format guide
Get the support you need to ensure regulatory documentation compliance internally and towards authority. This course gives insights and practical advise to current requirements and tools as well as a sneak-peak into the near future solutions.
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Regulatory Strategies
This two day course gives 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.
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Regulatory Affairs Academy
Build your Regulatory Affairs and life science expertise with Läkemedelsakademin
A program of 11 courses designed for you who aspire to work within regulatory affairs in the pharmaceutical industry. Whether you are already on your regulatory affairs career path, or you currently work in another area of the life science sector ,the Academy is here to support your goals.
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Nordic Regulatory Affairs Meeting 2025
Nordic Regulatory Affairs Meeting 2025 brings the Nordic authorities and pharmaceutical industry operators together on the latest news about the hottest topics discussed within Regulatory Affairs. Welcome!
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Pharmacovigilance - Basic course
The course gives a broad and basic knowledge and understanding of the drug safety area and its current legislation. Suitable for those new to their role and those already active in the field, whishing to update their knowledge and discuss the application of current regulations.
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Boost Your Career or Make an Impact
If you work in pharmaceuticals or with medical devices, Apotekarsocieteten is your association.
Apotekarsocieteten provides a network and platform for sharing knowledge, while also giving you the opportunity to make a broader impact.
Vad är Regulatory Affairs?
Regulatory Affairs (RA) is the key function that ensures the company’s regulatory compliance, from early development to approval, further product development and maintenance. The regulator role engages with authorities and collaborates across disciplines with colleagues from research and development, product development and delivery, clinical development, medical issues, patents and trademarks, market access, and marketing and sales. Regulatory is an important strategic advisor who must understand and interpret both regulatory requirements and data from clinical development, as well as a project manager with a good sense of order.
As new and more complex pharmaceutical regulations are continuously implemented, the need for regulatory expertise in life science is growing.
Vad är Farmakovigilans?
Pharmacovigilance is the science of collecting, detecting, assessing, monitoring, and preventing side effects of drugs. Before a medicine is approved, it is tested in clinical trials under controlled conditions in order to be able to measure the effects accurately. When the drug is finally approved, many more factors play a role in the drug’s intended and unintended effects and in interactions with other drugs. That is why it is of utter importance that a medicine is continously monitored even after approval for use.