Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Volumn 53, Issue 1, 2010, Pages 24-29

  Salmikangas, P ^a   Flory, E ^b   Reinhardt, J ^b   Hinz, T ^b   MacIulaitis, R ^c  

^a NATIONAL AGENCY FOR MEDICINES   (Finland)

^b PAUL EHRLICH INSTITUT   (Germany)

^c KAUNAS UNIVERSITY OF MEDICINE   (Lithuania)

Author keywords

ATMP; Cell based therapy; Regenerative; Regulatory

Indexed keywords

ARTICLE; CELL TRANSPLANTATION; CLINICAL TRIAL; EUROPE; FINANCIAL MANAGEMENT; GENE THERAPY; GENE TRANSFER; HEALTH CARE QUALITY; HUMAN; LEGAL ASPECT; PRACTICE GUIDELINE; TISSUE ENGINEERING;

CELL TRANSPLANTATION; CLINICAL TRIALS AS TOPIC; EUROPE; GENE THERAPY; GENE TRANSFER TECHNIQUES; GUIDELINES AS TOPIC; HUMANS; MARKETING OF HEALTH SERVICES; QUALITY ASSURANCE, HEALTH CARE; TISSUE ENGINEERING;

EID: 77249106993     PISSN: 14369990     EISSN: 14371588     Source Type: Journal    
DOI: 10.1007/s00103-009-0991-5     Document Type: Article

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