Ingrid Schwarzenberger | Head of Global Regulatory Affairs Biopharmaceuticals
Sandoz Biopharmaceuticals Gmbh

Ingrid Schwarzenberger, Head of Global Regulatory Affairs Biopharmaceuticals, Sandoz Biopharmaceuticals Gmbh

Ingrid is Global Head Regulatory Affairs Biopharmaceuticals at Sandoz Biopharmaceuticals leading a team dedicated to biosimilar submissions handling all regulatory activities worldwide for the 3 marketed products (Omnitrope, Binocrit and Zarzio/Zarxio) and for numerous ongoing development programs.
Ingrid has been working on the biosimilar submissions of Omnitrope® (Somatropin) - the first biosimilar product approval ever - in Europe, USA, Australia, Japan, and Canada as well as in many other countries globally, and played a leading role in the establishment of the regulatory framework of Biosimilars in Europe. She was also responsible for the successful registrations of Binocrit® (Epoetin alfa), the first complex biosimilar product approved ever, and of Zarzio® (Filgrastim). These 3 products are approved in over 60 countries of the world. 
A further milestone in the history of Biosimilars which was achieved under her responsibility was the approval for the first Biosimilar product ever in the USA: Zarxio®, the Sandoz filgrastim.
Ingrid joined Sandoz in 1984, has held various positions within QA and Regulatory Affairs and became responsible for the Biopharmaceuticals regulatory affairs team in 2001. 
Ingrid is also an active member of the MfE working group dedicated to  biosimilars, named the “European Biopharmaceuticals Group” (EBG). MfE stands for “Medicines for Europe” (formerly known as the European Generics Association (EGA)).
Ingrid holds a M.Sc. in biology from the University of Innsbruck, Austria.

Appearances:



Biosimilars Day 1 - Tuesday 31st October 2017 @ 09:30

Switch studies versus demonstrating interchangeability

  • US Interchangeability requirements: analysis and feasibility
  • Industry comments
  • European perspective
  • Switch studies: design and results

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