The Faculty of Pharmacy mobilising regulatory forces

Access to regulatory competencies: to understand and apply the regulations that surround a drug during its entire lifecycle, is a prerequisite for Sweden to consolidate a long-term position as leading life science nation. Historically, industrial giants educated their employees in the subject, but with the entry of smaller, niche companies, the need for knowledge is increasing, and now the Faculty of Pharmacy is leading an effort to train a new generation of experts.

“In dialogue with the Swedish Medical Products Agency, the industry and a number of other organisations, we have mapped the needs for competence and space to combine our strengths in the regulatory fields. We recently presented a report that identify both a desire for broad cooperation and potential ways forward,” says Anja Sandström, Deputy Dean for first and second cycle education.

Among the initiatives that have already found an efficient form is Drugs – Quality Assurance and Regulatory Requirements (Läkemedel – Kvalitetssäkring och Regulatoriska krav), a freestanding course where Uppsala University, in collaboration with experts from industry and authorities, provides knowledge about processes and control systems within drug development. The course is arousing great commitment, not least among the many pharmacy students who experience a first meeting with their future employers.

“The participants really appreciate interacting with our guest lecturers who give them both up-to-date knowledge and important networks for summer jobs and degree projects. Another highlight is the study visit to AstraZeneca's site in Östertälje, where the students see that what they learn in Uppsala is exactly what the industry is asking for. In short, this is an opportunity to both broaden perspectives and add extra weight to any CV,” say course leaders Ann-Sofie Persson and Josefina Nordström.

More joint platforms are now being prepared in Uppsala's Science Park. At a meeting arranged by the Faculty of Pharmacy, Agneta Larhed, Senior Consultant at RegSmart, highlighted the Master of Science Programme in Pharmacy as the right foundation to build on. At the same forum, Monica Lidberg of the Swedish Medical Products Agency advocated adjunct employees as an effective way to bridge academia and authorities.

“All parties agree that collaboration is the way forward, and next we will optimize the format for the journey we have already begun. The fact that we are doing this with broad commitment and a well-founded action plan gives us every reason to look optimistically at the important work that lies ahead,” states Dean Mathias Hallberg.

FACTS

• Regulatory science is a broader term encompassing the study of scientific and technical principles that underlie regulations within a specific industry.
• Regulatory affairs is the practical application of these regulations.

LEARN MORE

• Utbildning och forskning inom regulatoriska vetenskap och/eller ”regulatory affairs” vid Farmaceutiska fakulteten – Nuläge och framtid Pdf, 154 kB. (Report, in Swedish)
• Läkemedel – Kvalitetssäkring och Regulatoriska krav (7,5 hp)

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text: Magnus Alsne, photo: Mikael Wallerstedt