Birka Lehmann
Senior Expert, Drug Regulatory Affairs; Lecturer, Friedrich Wilhelm University
Fellow of DIA
Q&A
When did you realize you wanted to work in regulatory affairs?
When I started to work in a National Competent Authority (BfArM), the interaction of legal and scientific topics seemed challenging and very interesting.
In your opinion, what is the greatest challenge in your field?
To bring the different stakeholder/stakeholder interests together for the benefit of the individual patients and public health.
What in your opinion is the biggest gap between research and practice in your field?
The development of science in the medicinal arena and the development of new medicinal products have to be in line with legal requirements with respect to the protection of public health. It is always a challenge to bring new treatment options to the patient in a safe and timely manner.
Where do you see your field going? What is your vision of the field in 2030?
The mission of all competent authorities in the EU is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public health. Setting standards and the development of guidelines, not only for the European Union, is a great challenge. More and early cooperation with external parties, in particular with patient representatives and healthcare professionals, is key – as is informing the public on the safety of medicines.
What advice would you give your younger self about to enter the “real world?”
Be open, have no reservations. Also, it’s a greater challenge to work with patient communities at the interface between law and science rather than working with patients directly.
Imagine a day without work, the internet, and any other obligations. What would you do?
Reading and communicating face-to-face with friends.
How has DIA helped you?
DIA has helped me understand the whole system of drug regulatory affairs—bringing science to benefit patients.
What would you like to see DIA do for you in the future?
Giving me an opportunity to be involved in future, new issues.