Dr Franziska Huber

My main areas of practice
Our clients include national and international companies. My particular focus is on advising pharmaceutical companies and manufacturers of medical devices on regulatory matters. I also provide support in the negotiation and drafting of various types of contracts in the Life Sciences sector.

In addition, as part of the Life Science Regulatory Practice Group at Fieldfisher, I advise on market access, particularly with regard to reimbursement and pricing of medicinal products and medical devices in the inpatient and outpatient service sector of the SHI, including method assessment procedures before the G-BA as well as negotiations with statutory health insurance funds and the SHI-SV.

The regulatory advisory practice includes in particular the placing on the market of medicinal products and medical devices (conformity assessment procedures, marketing authorisation, distribution, GDP, contracts between actors in the supply chain), wholesale authorisations, compassionate use and single importation, clinical trials and good manufacturing practice.

I advise our clients in German and English.

Personal engagement  
I am involved as an editor at breakingthrough and am a member of the DJB.

I am a lecturer at the University of Augsburg for Pharmaceutical and Medical Device Law.

My background
I studied in Augsburg and worked there as the Managing Director of the Institute for Bio-, Health- and Medical Law at the University of Augsburg during my doctorate on a Medical Law topic.

After my legal clerkship, which included a stop in Washington D.C., I worked as a lawyer in an international law firm in the Life Sciences and Private Equity sector.