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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.

BIOGRAPHY

Birka Lehmann, MD, was Head of Executive Department EU and International Affairs of the Federal Institute for Drugs and Medical Devices (BfArM) from 2011 to 2016. Lehmann studied Medicines at the Free University Berlin and trained at the Kinderklinik Norderney. Her working experience includes nine years of preclinical assessment in the Pharmacology and Toxicology division of BfArM. She also served as head of the Decentralised Procedure unit (1996-2002) and as deputy head of EU Division (2000-2002). From 2002 to 2006 she joined the European Commission, Directorate-General Enterprise and Industry as expert on secondment to the Pharmaceuticals unit responsible for inter alia Marketing Authorisation and implementation of the Clinical Trials Directive. From 2006 to 2011, Lehmann was head of the Division 3 Marketing Authorisation procedure at BfArM. She was also a member of the Paediatric Committee at the European Medicines Agency until the end of 2015.