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.