Professional Experience / CV

Name: Dr. Klaus Kehne
Qualifications: Pharmacist
PhD Pharmaceutical Technology
Core Competences: 30 years of experience from the pharmaceutical and IMP contractor industry in all areas of IMP management and pharmaceutical development
Key Focus: Specialised on technological, regulatory and operational topics: application of modern technologies and IT systems, randomisation and efficient use of IVRS, creation of optimal packaging design (compliance concepts), labelling, inventory management and distribution, MES and IVRS, automation in IMP packaging, GxP compliance and transfer into best practice, specific GxP training for IMPs, coaching of clinical supply unit staff, efficient IMP project management, contractor auditing, inspection preparation, outsourcing management
Professional Experience: Head of Pharmaceutical Development Spitzner Arzneimittel GmbH (1979-81)
Head of clinical supplies and logistics at Boehringer Mannheim / Roche Diagnostics (1981-98)
Managing Director Almedica GmbH (international contract packager IMPs) (1999-2002)
Co-Founder and Partner of PharmLink Consultants, Local Office Mannheim (2002-2007)
Co-Founder and Partner of CS² - Clinical Supplies Consulting Services, Local Office Mannheim (2007-Present)
Publications: Numerous presentations, seminars and workshops at international conferences in all areas of IMP management (mostly as chairman and/or invited speaker)
Languages: German (native)
English (fluent)
Specifics: Automation in IMP packaging, application of standard software tools, IVRS and MES to support and improve the IMP supply process, IMP supply chain management
Professional Affiliations: APV, ISPE, DIA