Why is the seemingly boring topic of Regulatory Affairs so important?
We enable QIAGEN to sell its products. It’s as simple as that!
How did you get into Regulatory Affairs?
While working for a start-up supporting the clinical trials of pharma companies, we began developing companion diagnostic tests to help them obtain regulatory approval for their products in the U.S.
What exactly are companion diagnostics?
A companion diagnostic test provides information to a health care professional that is essential for the safe and effective use of a corresponding drug.
What does your job involve?
I’m responsible for a team that spends around 80 % of its time supporting projects that are developing companion diagnostics. The regulatory requirements vary from country to country and are always changing. We need to prove to regulatory authorities that our products are safe and effective. Up to now, only the U.S. and Japan required co-approval of a companion diagnostic to register a corresponding drug. But in 2017, the new EU IVD regulation will contain specific companion diagnostic requirements. Registration in the big markets can be complex, expensive and take a long time.