QUALITY MANAGEMENT

 

PD Dr. Peter–J. Kramer, former global Leader of Quality Assurance in Pharme F&E — Organisation

  • Responsible Global Head (Vice-President) of Toxicology and Safety Pharmacology (> 100 employees, Chemicals and Drugs) (GLP-Good Laboratory Practice, certified quality), then
  • Responsible Global Head (Vice-President) of worldwide Quality Management-Unit (GLP, GMP, GCP) (Chemistry, Biochemistry, Pharmacology, Toxicology, DMPK, IT), incl.
  • Initiation and establishment of Quality Managements Systems (QMS) in an international Research Organisation (about  1,600 employees)

Publications (Selection)

  1. La Relazione del Esperto nella Procedura “Multi-Stato”, P.-J. Kramer, Cronache Farmaceutiche 2:50-51 (1986)
  2. Erfolgsfaktor Qualität in der Pharmaforschung, P.-J. Kramer, B. Pohl, Nachr. Chemie 54, Juli/August 2006
  3. Current experiences with a quality management system for non-clinical research and development in pharmaceutical industry, Barbara Pohl, Stephanie Simon, Peter-Jürgen Kramer, Accred Qual Assur 13:511-521 (2008)

  4. Kramer P-J, Bode G and Bass R (2024) Why CEOs need advanced education and training for optimizing decisions in the development of innovative medicinal products? Justification and recommendation. Front. Pharmacol. 15:1480338. doi: 10.3389/fphar.2024.1480338

 

  1. peter-juergen-kramer.de>>
  2. Home>>
  3. R&D MANAGEMENT = CONFLICT RESOLUTION>>
  4. QUALITY MANAGEMENT>>