We had an interview with Petra, Noor, Eva and Amr who all participate in the very first Regulatory Affairs Academy (RAA) at Läkemedelsakademin. They all agree that the RAA offers everything from the whole picture down to the details in regulatory affairs. The access to a diversity of lecturers is one important strength, and the knowledge they acquire will facilitate future contacts with the authorities such as the Medical Products Agency.

Who are these course participants, what is each one’s background and what plans do they have for using their new knowledge and insights after the program?

– I signed up to RAA because I wanted to get a better picture of the regulatory landscape all the way from idea to marketing approval of a medical product, says Petra.
– I currently work at the university hospital in Skåne, mainly within clinical trials. I will soon move on to work with new products developed by the academy with a hospital-centric production, and then I will need to master the whole process. Therefore “Biologics drug development”, ”CMC”, ”GDP” and ”Regulatory strategies” were some of the courses I was looking forward to from the start, but now I look forward to ALL courses in the package!
– After the first four courses, I have already received many valuable pieces to the overall picture, Petra concludes.

– RAA is a perfect opportunity for me to develop myself and to get access to a position in the pharmaceutical industry, says Noor. She is Bachelor in Pharmacy Science and has a trainee-education to become a pharmacy manager. Currently she works as a consultant.
– So far, the program has given me a deepened and “nuanced” knowledge of the pharma industry as a whole, she says. I really appreciate the way the RAA is built up. It works really well to follow the e-courses and the recorded courses online. I feel like I have access to the courses as a whole – and I do not miss anything by not attending a course on site. You could actually follow the course from anywhere in the world – the course package is so clear!

Eva just started her own company and needed to develop her skills and knowledge in the regulatory field.
– RAA gives me the access to information in detail in all the relevant areas. This is invaluable to me, she says.
– It is so fantastic to get the access to Sweden’s top experts in the regulatory field and to the experts at one of Sweden’s most important authorities: the Medical Products Agency, says Eva. What I learn now will help me onwards in my contact with the authorities. It will help me asking the right questions and talking to the authorities efficiently, without “wasting their time”.

Eva concludes that the amount of information you get in RAA is massive.
– You cannot learn all in detail, but you get the references and a library to return to when you are about to do specific tasks in real life.

Amr signed up for the RAA because he wanted to get the full picture of the approval process in the EU for new medicines.
– I have a background from the pharma industry in the Middle East, and we often look at the EU as a “role model” when it comes to regulatory requirements and quality assurance, says Amr.
– I think that the program is very good. He points out one important strength of the programme: the diversity of lecturers with different experiences and perspectives, for example experts from the MPA, entrepreneurs in the development of pharmaceuticals as well as consultants from different areas.

Läkemedelsakademin wishes Good Luck to all participants at the Regulatory Affairs Academy, and hope that the knowledge and insights you get will help you to the next career step that you are aiming for, and contribute to life science in Sweden.

A big thanks to the participants who shared their views and experiences:

Petra Johnels
PhD, ATMP coordinator/project lead
Cell and gene therapies
Skåne University Hospital

Noor Atashgon
Prescriptionist, Gothenburg University
Consultant, Prodigy Consulting AB

Eva Thunell
Founder and Owner, Eternal AB

Amr Kandeel
Pharmacist, Emergency Department
Hospital pharmacy unit Malmö
Department of strategic care development and safety
Skåne University Hospital.