Hirschfeld Regulatory Affairs Consulting GmbH


Hirschfeld Regulatory Affairs Consulting

business activities

  • Development and review of regulatory strategies for development projects and marketed products (line extensions, variations, repeat use procedure applications)
  • Preparation and submission of applications for clinical trials, new drugs, orphan drug desginations and variations
  • Preparation and conduct of scientific advice meetings

curriculum vitae

Dr. Jürgen Hirschfeld

Managing Partner
Education

  • 7/1990 PhD, University of Berlin
  • 12/1985 – 7/1990 Scientific assistant, Free University of Berlin
  • 11/1985 Examen as Pharmacist, Chamber of Pharmacists, Berlin
  • 11/1984-10/1985 Practice in Sedan-Apotheke, Berlin
  • 9/1984 Examen in Pharmacy , Free University of Berlin
  • 4/1981-7/1984 Study in Pharmacy, Free University of Berlin
  • 9/1980 Examen male nurse, Düsseldorf
  • 9/1977-9/1980 Education male nurse, Düsseldorf
  • 7/1976-9/1977 Military Service, Hamburg
  • 5/1976 Abitur

Work experience

Since 01/2020 Managing Partner Hirschfeld Regulatory Affairs Consulting GmbH

09/2018-03/2020 Independent Consultant for Regulatory Affairs
  • Development of regulatory strategies for products under development
  • Conduct of a successful Orphan Drug Designation procedure in the EU

01/2017-02/2020 Senior Director, Head of Global Regulatory Affairs & Pharmacovigilance Life Molecular Imaging GmbH
  •  See below


read the complete CV

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