Marketing regulatory oversight of advanced therapy medicinal products (ATMPs) in europe: The EMA/CAT perspective

Advances in Experimental Medicine and Biology

Volumn 871, Issue , 2015, Pages 103-130

  Salmikangas, Paula ^a,b   Schuessler Lenz, Martina ^a,c   Ruiz, Sol ^a,d   Celis, Patrick ^a   Reischl, Ilona ^a,e   Menezes Ferreira, Margarida ^a,f   Flory, Egbert ^a,c   Renner, Matthias ^c   Ferry, Nicolas ^a,g  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b Finnish Medicines Agency   (Finland)

^c PAUL EHRLICH INSTITUT   (Germany)

^d Laboratory of Microbiological Control Biological Products and Biotechnology Division Agencia Española de Medicamentos y Productos Sanitarios   (Spain)

^e AUSTRIAN AGENCY FOR HEALTH AND FOOD SAFETY   (Austria)

^f INFARMED)   (Portugal)

^g French National Agency for Medicines and Health Products Safety   (France)

Author keywords

ATMP; Cell therapy; Gene therapy; Regulation; Risk based approach; Tissue engineering

Indexed keywords

ADVANCED THERAPY MEDICINAL PRODUCT; BIOLOGICAL PRODUCT; CELL BASED MEDICINAL PRODUCT; EXCIPIENT; GENE THERAPY MEDICINAL PRODUCT; SOMATIC CELL THERAPY MEDICINAL PRODUCT; TISSUE ENGINEERED PRODUCT; UNCLASSIFIED DRUG; NEW DRUG;

CELL THERAPY; CELLULAR DISTRIBUTION; CERTIFICATION; CLINICAL EFFECTIVENESS; DOSE RESPONSE; DRUG DISTRIBUTION; DRUG MANUFACTURE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPE; EUROPEAN MEDICINES AGENCY; EXPERIMENTAL ANIMAL; GENE DELIVERY SYSTEM; GENE THERAPY; GENETIC MANIPULATION; GOOD MANUFACTURING PRACTICE; HUMAN; LAW; LEGAL ASPECT; MARKETING; NONHUMAN; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; QUALITY CONTROL; RISK BENEFIT ANALYSIS; TISSUE ENGINEERING; TOXICITY TESTING; TRANSGENIC ORGANISM; ANIMAL; BIOLOGICAL THERAPY; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG CONTROL; DRUG SCREENING; ETHICS; LEGISLATION AND JURISPRUDENCE; METHODOLOGY; PATIENT SAFETY; PRACTICE GUIDELINE; PROCEDURES; TRANSLATIONAL RESEARCH;

ANIMALS; CELL- AND TISSUE-BASED THERAPY; CLINICAL TRIALS AS TOPIC; DRUG AND NARCOTIC CONTROL; DRUG EVALUATION, PRECLINICAL; DRUGS, INVESTIGATIONAL; EUROPE; GENETIC THERAPY; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; MARKETING; PATIENT SAFETY; PRACTICE GUIDELINES AS TOPIC; QUALITY CONTROL; RESEARCH DESIGN; TRANSLATIONAL MEDICAL RESEARCH;

EID: 84941890402     PISSN: 00652598     EISSN: 22148019     Source Type: Book Series    
DOI: 10.1007/978-3-319-18618-4_6     Document Type: Chapter

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