Proceedings: International regulatory considerations on development pathways for cell therapies

Stem Cells Translational Medicine

Volumn 3, Issue 8, 2014, Pages 879-887

  Feigal, Ellen G ^a   Tsokas, Katherine ^b   Viswanathan, Sowmya ^c   Zhang, Jiwen ^d   Priest, Catherine ^a   Pearce, Jonathan ^e   Mount, Natalie ^f  

^a California Institute for Regenerative Medicine   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^c PRINCESS MARGARET HOSPITAL   (Canada)

^d GE HEALTHCARE   (United States)

^e MEDICAL RESEARCH COUNCIL   (United Kingdom)

^f GUY S HOSPITAL   (United Kingdom)

Author keywords

Cell therapy; Stem cells; U.S. food and drug administration

Indexed keywords

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; ASSAY; CANADA; CARCINOGENICITY; CELL THERAPY; CELL TYPE; CLINICAL ASSESSMENT; CLINICAL DEVELOPMENT PLAN; CLINICAL TRIAL (TOPIC); DRUG DISTRIBUTION; EMBRYONIC STEM CELL; EUROPE; FOLLOW UP; GOOD MANUFACTURING PRACTICE; HEALTH CARE ORGANIZATION; HEALTH PROGRAM; HUMAN; INTERNATIONAL REGULATORY GUIDANCE; JAPAN; KNOWLEDGE; MARKET KNOWLEDGE; NONHUMAN; ORGANOGENESIS; POTENCY ASSAY; REGENERATIVE MEDICINE; REGULATORY MECHANISM; RISK BENEFIT ANALYSIS; STANDARDIZATION; SURGICAL TECHNIQUE; TRAINING; UNITED STATES; WORKSHOP;

CELL THERAPY; STEM CELLS; U.S. FOOD AND DRUG ADMINISTRATION;

ANIMALS; CELL- AND TISSUE-BASED THERAPY; COOPERATIVE BEHAVIOR; DIFFUSION OF INNOVATION; HEALTH POLICY; HUMANS; INFORMATION DISSEMINATION; INTERNATIONAL COOPERATION; PATIENT SAFETY; POLICY MAKING; REGENERATIVE MEDICINE; RISK ASSESSMENT; RISK FACTORS; TISSUE BANKS; TRANSLATIONAL MEDICAL RESEARCH;

EID: 84905455203     PISSN: 21576564     EISSN: 21576580     Source Type: Journal    
DOI: 10.5966/sctm.2014-0122     Document Type: Article

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