Basics of Regulatory Affairs

About the course

Are you looking for broad and essential knowledge of Regulatory Affairs? Our popular 3-day course in fundamental Regulatory Affairs gives a comprehensive picture and is a platform for your further development in the area. The course is given in English.

Who should attend?

This course is perfect if you are new in your role within Regulatory Affairs and need an overview of current regulations, processes and documentation. It also suits you who hold more experience within the Regulatory Affiars field and are looking to update or confirm your knowledge. In addition, it’s an opportunity to exchange experience and best practises with colleagues regarding e.g. practical application of current regulations and guidelines.

Learning objectives

The course gives a comprehensive picture of Regulatory Affairs. After the course, you will have a broad knowledge of Regulatory Affairs and a platform for further development in the area.

The engagement from the teachers was fantastic. Their passion for Regulatory affairs truly shone through, and it made the learning experience so much more enjoyable. The teacher’s extensive knowledge and experience, especially with historical contexts and the evolution of various regulations and processes, were incredibly valuable. This background information helped me close many gaps in my understanding. Additionally, the course coordinators were excellent and always ready to assist. The provision of coffee, breakfast, and fika was great, keeping us energized and able to focus. Thank you!

In depth education on navigation and strategy of regulatory affairs with really good lecturers

Fantastic presenters and a very well balanced programme. Excellent course!

To have input and lectures from both sides of RA – the MAH and the authorities

I recently completed the course Basics of Regulatory Affairs and truly appreciated the insights it provided. The course offered a clear understanding of how regulatory processes work, which will positively impact my day-to-day work and communication as part of Medical Affairs.

Whether in smaller or larger pharmaceutical companies, regulatory affairs plays a crucial role in shaping the work- even of medical scientists. This training significantly enhances mutual understanding and fosters better collaboration between Medical Affairs and Regulatory teams.

Continuous learning is key to driving impactful partnerships—and this course was a great step forward!

Katherina Zakikhany-Gilg

PhD, Sr Medical Affairs Scientist Infectious Diseases, Pfizer

Jag gick in i Basics of Regulatory Affairs-kursen med en medvetenhet om att regulatory är ett kritiskt område som jag behövde förstå bättre i min roll.

Även om jag inte arbetar direkt med regulatoriska frågor så inser jag att en grundläggande förståelse för området är avgörande för att kunna fatta välgrundade strategiska beslut.

Kursen gav mig precis den insikt jag behövde. Jag uppskattar särskilt hur den lyfte fram sambandet mellan regulatoriska processer och affärsstrategi – hur timing, resursplanering och marknadstillträde direkt påverkas av regulatory-arbetet. Det har gjort mig till en bättre samtalspartner gentemot regulatory-funktionen och gett mig verktyg att bättre förstå de utmaningar och möjligheter som regulatoriska frågor innebär.

Att förstå grunderna i området har också gett mig större trygghet i ledningsbeslut och hjälpt mig att ställa bättre och fler frågor i strategiska diskussioner. Jag kan varmt rekommendera kursen till andra i ledande roller som vill bygga en starkare grund för sitt beslutsfattande inom läkemedel och regulatory affairs.

Robert Svanström

VD och affärsutvecklare på Addeira Pharmaceuticals

Course instructors

Henrik Fant

Gedeon Richter

Helena Björkman

Avia Pharma

Reyhane Rezai

Lobsor Pharmaceuticals AB

Marianne Andersson

Former AstraZeneca R&D

Jimmy Cedervall

Läkemedelsverket/Swedish Medical Products Agency

Emelie Bergman Perland

Läkemedelsverket/Swedish Medical Products Agency

Marielle Svensson

Läkemedelsverket/Swedish Medical Products Agency

Elin Svensson-Wallin

Läkemedelsverket/Swedish Medical Products Agency

Course outline

The course days are structured around lectures and discussions – individually and in groups. From the program:

Overview of European regulations
The authority role
Regulatory Affairs role in pharmaceutical development
Development phases, from selection of substance to market authorisation approval
Approval Procedure
Product life-cycle management
Variations and line extensions
Market authorisation application: structure and content
Product information
Practical application and discussions