Regulatory Affairs Academy

– building your Regulatory Affairs expertise.

What is Regulatory Affairs Academy?

The Regulatory Affairs Academy by Läkemedelsakademin (the Swedish Academy of Pharmaceutical Sciences) gives you

  • knowledge of the regulatory requirements for the different phases of drug development, before and after product approval*, on a global level, emphasising on Europe
  • skills to plan, project manage and carry out the regulatory work to support optimized drug development, product safety and availability on the market and ensure that the companies meet the regulatory requirements set by authorities
  • competence to interpret and analyse the regulations to be able to both operate and advise during the different phases of drug development before and after product approval*.

*Medicines Agency authorisation to market a medicinal product in a specific country

Regulatory Affairs Academy consists of 11 separate courses, altogether covering the regulatory role and requirements in the different phases of drug development before and after product approval.

All included courses are found further down on this page.

Regulatory Affairs Academy – for whom?

The Academy is meant for you who aim to work within regulatory affairs for the pharmaceutical industry in Sweden. You may already have started your regulatory affairs career and need to further build and update your knowledge and skills, or perhaps you work within another part of the life science sector right now, but have your sights set on a position within the regulatory affairs area.

Your recommended prerequisites to be able to fully benefit from the education and to be an attractive future employee in the life science industry after completing the education is: a degree in for example pharmacy, biomedicine, medicine, molecular biology or chemistry, or professional experience where equivalent knowledge has been acquired.

Execution and format

The training program enables a combination with other studies or work. We want your educational journey to be agile. Therefore, all included courses can be completed online from your preferred location – whether that is from home or from your workplace, in consultation with your employer.

The courses are carried out as online live seminars with lecturers, pre-recorded seminars of lecturers or e-learnings. For some of the live seminars, there may be opportunities to participate live on site in Stockholm if you wish and if seats are available.

We recommend you to complete the included courses according to the categorisation 1-4 marked on each course:

You can choose to complete the Academy during one year at 10-15% study pace (next start: autumn 2024) or during six months at 20-25% study pace during the period: January 2024 – June 2024.

Once you have completed all included courses, you will receive your Diploma from Läkemedelsakademin – documenting your education in regulatory affairs.

If you have already completed any of the included courses at Läkemedelsakademin within the last two years (i.e. after October 2021) and hold a valid course certificate, you can apply for transfer of credits. Contact us if you have questions about credit transfer.

What is included in the Regulatory Affairs Academy?

  • 11 stand-alone courses developed by Läkemedelsakademin together with industry experts, in a package that offers a 25% discount compared to buying the courses individually.
  • 25% discount on additional courses and events offered by Läkemedelsakademin within the Regulatory Affairs area during the time of your education
  • A personal Diploma from Läkemedelsakademin showing your education in regulatory affairs
  • Possibility of free membership in Apotekarsocieteten (the Swedish Pharmaceutical Society) during the time of your education. Read more about this offer further down on this page.

Included courses

Biologics Drug Development – 3 day course
Online recording
Course language: English

Basics of Regulatory Affairs
Online recording
Course language: English

Introduction to Life Science
E-learning
Course language: English

Introduction to advanced therapies – ATMP
E-learning
Course language: English

Introduction to the EU Medical Device
Regulation for combination products
E-learning
The course will be available 2024
Course language: English

Nordic Market Access
E-learning
Course language: English

CMC
Online
Course language: English

Regulatory documentation, content and format guide
Stockholm/Online
2024-05-07
Course language: English

Regulatory strategies
Stockholm/Online
2024-05-29 – 2024-05-30
Course language: English

GDP Basic
E-learning
Course language: English. Also available in Swedish

Marketing Compliance for Dummies
E-learning
The course will be available April/May 2024
Course language: English

As a Regulatory Affairs Academy participant, You get a 25% discount on the following:

Farmakovigilans Grundkurs 

2024 – date to be communicated

Supporting your Regulatory career journey

We want to support you in your Regulatory journey. We know the importance of continuous exchange of experience and networking between industry colleagues, throughout the professional life. Therefore, we want to offer you as a participant of the Regulatory Affairs Academy a free membership in Apotekarsocieteten during the time of your studies (a maximum of 2 years whereafter you can choose to continue your membership at your own cost). As a member of Apotekarsocieteten, you get access to a unique network of professionals in the entire pharmaceutical field and the opportunity to influence both what activities the association arranges and the development in the life science field in Sweden.

Apotekarsocieteten also acts as a referral body, responding to consultations issued by the government, the parliament, and national authorities in matters concerning pharmaceuticals. As a member, you can contribute to the society’s advocacy efforts – influence what issues we focus on and how we work to inform political decision-making and shape policy.

What you get as a member

  • Membership in your local and the scientific section you select
  • Participate free of charge in our activities
  • Newsletters from Apotekarsocieteten and Lakemedelsvarlden.se (in Swedish)
  • Being a part of a professional network, that includes diverse competences and skills within the pharmaceutical field
  • Reduced price of congresses, symposiums and books
  • Priority access to our scholarships
  • Information to your e-mail about vacancies in the field of pharmaceutical
  • Exclusive networks and mentorships, e.g. younger professionals
  • Opportunity to influence political decision-making e.g. by being a part of political referrals or help shape policies
  • Electronic certificate after participation in activities
  • Influence and contribute with ideas for activities

A membership in Apotekarsocieteten is always personal and voluntary and is based on your own commitment. Your free membership will take effect upon payment of the Regulatory Affairs Academy and after your own registration of membership.

Enrollment to Regulatory Affairs Academy

Click here to be redirected to enrollment page 

  • Participation fee excl. VAT (for companies): 63 900 SEK
  • Participation fee incl. VAT (for individuals): 79 875 SEK
    Partial payment is possible. Contact us for more information.

Don’t miss! You can apply for a scholarship for continuing and further education at Apotekarsocieteten.  Read more here!

Läkemedelsakademin reserves the right to postpone or cancel included courses at any unforeseen event. Should this happen, participants in the Regulatory Affairs Academy program receive a voucher for the course’s regular price, to use for any course in Läkemedelsakademin total current course offering within 2 years.

Kalendarium

Datum DatumUtbildningDagarPlats
e-kurs / kostnadsfriIntroduktion till avancerade terapier – ATMP
Online
Online
e-kursGDP grundkurs
Online
Online
e-kursGDP Basic
Online
Online
web course / free of chargeIntroduction to advanced therapies – ATMP
Online
Online
e-kursGDP grundkurs – för dig inom transport
Online
Online
e-kursGDP Basic – management team
Online
Online
e-kursGDP Basic – manufacturing
Online
Online
e-kursGDP Basic – transport
Online
Online
e-kursGDP grundkurs – för dig i företagsledningen
Online
Online
e-kursGDP grundkurs – för dig inom tillverkning
Online
Online
web courseNordic Market Access
Online
Online
Jan - June 2024Regulatory Affairs Academy
Online/Stockholm
Online/Stockholm
Aug 1 2024 - June 30 2025Regulatory Affairs Academy
Online/Stockholm
Online/Stockholm
e-kursGCP och klinisk prövning – från studiestart till avslut
Online
Online
e-courseIntroduction to Life Science
Online
Online
24 apr
2024
apr
24
Chemical-Pharmaceutical Documentation: Introduction to the CMC dossier and the Common Technical Documents (CTD) structure
Online
2Online
25 apr
2024
apr
25
Kvalitetsregister för forskning
Online
1Online
25 apr
2024
apr
25
Kvalitetsregister för forskning
Stockholm
1Stockholm
7 maj
2024
maj
07
Regulatory documentation, content and format guide
Stockholm
1Stockholm
7 maj
2024
maj
07
Regulatory documentation, content and format guide
Online
1Online
14 maj
2024
maj
14
Medicintekniska produkter – grundkurs
Stockholm
2.5Stockholm
29 maj
2024
maj
29
Regulatory Strategies
Online
2Online
29 maj
2024
maj
29
Regulatory Strategies
Stockholm
2Stockholm
4 jun
2024
jun
04
Train the trainer
Stockholm
2Stockholm
10 okt
2024
okt
10
GDP Fördjupning
Stockholm
1Stockholm
22 okt
2024
okt
22
GMP i Sjukvården
Stockholm
1Stockholm
21 nov
2024
nov
21
GDP i Praktiken – Grundkurs
Stockholm
1Stockholm
26 nov
2024
nov
26
Basics of Regulatory Affairs
Online
3Online
26 nov
2024
nov
26
Basics of Regulatory Affairs
Stockholm
3Stockholm
3 dec
2024
dec
03
Farmakovigilans Grundkurs
Stockholm
3Stockholm

Se fler

Contact person

Sandra Trost
Director of Continuing Professional Development Regulatory Affairs
sandra.trost@lakemedelsakademin.se
Phone. 08-723 50 04

”The regulations for pharmaceuticals are complex, constantly changing and governed by both national and international laws, regulations and guidelines. The Regulatory Affairs role requires an understanding of the entire drug development process, both before and after product approval, as well as an ability to project manage and to communicate and collaborate both internally and externally. Our lead star developing this course package is to give the participants the best possible platform for being the “regulatory octopus” needed for a successful life science sector in Sweden!”

Initiators, sponsors and partners

Science Skills/MultiHelix
Ursula Hultkvist Bengtsson, Chairman of the Board/CEO

”Life science in Sweden needs both an addition of regulatory personnel (e.g. newly graduated students and researchers) as well as up-skilling and re-skilling of already working people in Regulatory Affairs or related areas. Several companies act globally, and the availability of expertise is often a decisive factor of where a business should be located. The availability of expertise is central to Sweden’s life science strategy, which states that Sweden should be a leading life science nation. In the current situation, companies are competing for skills and the shortage risks hampering development in the pharmaceutical field and thus delaying patients’ access to medicines.”

Apotekarsocieteten’s section for Regulatory Affairs/Kapitel Tre

Eva Lilienberg, Member of the Board/CEO

”The life science industry in Sweden is a great place to learn the regulatory work. Sweden has and has had large companies functioning as nurseries for many regulatory professionals. In addition, the Medical Products Agency takes on a lot of responsibility in the EU work and persons from their staff find their way out to pharma companies and vice versa. Sweden is also a small country where many people know each other and can share experiences on a network basis, e.g. through Apotekarsocieteten. Läkemedelsakademin also plays an important role, with courses that continuously develop people throughout working life. Skills development is needed, not only for individuals but also for the Swedish pharma industry. This is to maintain a strong position when the company structure is shifting towards a larger amount of smaller companies where it can be more difficult to build a broad expertise.”

Astra Zeneca
Anne Litzén Forsman, Executive Director Regulatory Affairs Management

“This is a very important educational initiative for AstraZeneca. We are constantly seeking academic talent with regulatory affairs experience for different areas of our business in Gothenburg, Södertälje, and Stockholm. This type of education, although available in many other countries, does not currently exist in Sweden.”

Naturvetarna
Marita Teräs, Assessor

”As a union, we have initiated this training to strengthen our members’ career opportunities. Life science is the dominant sector for our members and we want to make it possible for more people to equip themselves with the required skills.”

Aptio Group
Sandra Larsson, Vice VD

”We wish to contribute with our expertise and experience to strengthen the industry with more employees who can work and assist in Regulatory Affairs”

The Swedish Medical Products Agency participates in some of the included courses.