• Zulassung und Qualitätsmanagement
    für biopharmazeutische Arzneimittel

  • Zulassung und Qualitätsmanagement
    für biopharmazeutische Arzneimittel

Veröffentlichungen

2024

  • Quality Standards for the international plasma product industry (IQPP)

2016

  • GMP Requirements: EU versus WHO
  • GMP Requirements for Raw Materials
  • How to compile an IMP Dossier

2014

  • Training of internal Auditors

2012

  • Future role of biomarkers and personalised medicine in development of new medicines

2011

  • Regulatory requirements for the characterisation of proteins during clinical trials
  • From Bench to Clinic: the value chain for biopharmaceuticals

2010

  • Challenges to nonclinical development of biotherapeutics

2009

  • Pitfalls during development of biotherapeutics

2005

  • European regulatory environment for medicinal products with a focus on medicinal products manufactured from human blood or plasma
  • European legal framework for licensing of medicinal products

BioReg Consultancy gibt gerne weitere Auskünfte an Interessierte. Bitte kontaktieren Sie BioReg Consultancy direkt.