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Franziska Huber

Dr Franziska Huber is a Senior Associate in Fieldfisher´s Munich office and advises on all regulatory issues in the Life Science sector. Our clients include national and international companies. Her particular focus is on advising pharmaceutical companies and manufacturers of medical devices on regulatory matters. She also provides 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, she advises 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. · Fieldfisher

GermanyLife Sciences, RegulatoryGerman, English

About

Dr Franziska Huber is a Senior Associate in Fieldfisher’s Munich office advising on regulatory matters in the life sciences sector, with a particular focus on pharmaceutical companies and medical device manufacturers. She also advises on market access (reimbursement and pricing in the SHI, including G-BA procedures and negotiations with statutory health insurance bodies), clinical trials, GMP, placing products on the market, distribution and related commercial contracts.

Practice areas

Life SciencesRegulatoryPharmaceuticalsMedical DevicesMarket AccessHealthcareClinical TrialsCommercial Contracts

Office

Expertise

Reimbursement & Pricing (SHI)G-BA method assessment proceduresNegotiations with statutory health insurance funds and SHI-SVMarketing authorisation & conformity assessmentDistribution & Wholesale authorisationsCompassionate use & single importationClinical trialsGood Manufacturing Practice (GMP)

Education

  • Doctorate (Medical Law), University of Augsburg
  • Studied in Augsburg

Languages

GermanEnglish