Barbara Valenta-Singer
Chief Medical Officer Fresenius-Kabi SwissBioSim
Previous work experience as
- Independent Clinical Consultant Dr Barbara Valenta-Singer Consulting e.U.
- Vice President Clinical Development Operations Shire ( Baxalta Acquisition)
- Vice President Clinical Development and Operations Baxalta Innovations
- Acting Head Global Clinical Development Baxter Bioscience
- Senior Director Global Clinical Operations Baxter Bioscience
- Medical Director Technical Assessment Due Diligence Baxter Bioscience
- Regional Medical/Regulatory/Quality Director for Austria and CEE,Wyeth Whitehall Export
- Trade Law Director for Wyeth Whitehall Export and Wyeth Lederle Pharma
- Medical&/Regulatory and Pharmacovigilance Director ,Pfizer Austria
- Medical & Regulatory and Pharmacovigilance Director,Pharmacia Austria
- Head Medical and Regulatory and Department SERONO, Austria
- Fellowship – Internal and Psychiatric Ward University Hospital of Vienna
- Research Assistant Pharmacological Institute University of Vienna, Research in CNS regulation of antihypertensive drugs
- Assessor Austrian Regulatory Authorities (preclinical and clinical)
Member of the Austrian Drug Evaluation Committee (sick funds/reimbursement)
- Board of Austrian Pharmacological Society (APHAR)
- Task force Rare Disease Europa Bio and EBE
- Working Party Advanced Therapies
- July 2010 -2013: permanent industry representative EUCERD (EU Commission
- Working party for Rare Diseases
Title: Biosimilar global development: after >10years are we closer ?
- FDA - EMA: how to explain and address different expectations for Equivalence margin, Confidence Interval, clinical endpoints, Reference products
- Why has interchangeability still not taken up?
- How does the practice of settlement interfere with the proposed benefits in case of interchangeability?