Info
- Utilizzare la checkbox di selezione a fianco di ciascun documento per attivare le funzionalità di stampa, invio email, download nei formati disponibili del (i) record.
Cost-contained regulatory compliance [[electronic resource] ] : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg
| Cost-contained regulatory compliance [[electronic resource] ] : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg |
| Autore | Weinberg Sandy <1950-> |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2011 |
| Descrizione fisica | 1 online resource (296 p.) |
| Disciplina | 615.1068/1 |
| Soggetto topico |
Medical instruments and apparatus industry - United States - Cost control
Medical instruments and apparatus - Inspection - United States Pharmaceutical industry - United States - Cost control Pharmaceutical industry - Inspection - United States |
| ISBN |
1-118-00227-X
1-283-02560-4 9786613025609 0-470-93350-X 0-470-93351-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Controlling regulatory costs -- Clear operation definitions of requirements -- Pre-regulatory audits -- Quality by design -- Outsourcing -- Electronic submissions -- Emea/fda coordination -- Managing FDA inspections -- Risk assessment -- Cases -- Cost containment analysis -- Managing regulation in times of chaos -- International regulation -- Cost contained regulatory compliance. |
| Record Nr. | UNINA-9910133581103321 |
Weinberg Sandy <1950->
|
||
| Hoboken, N.J., : John Wiley & Sons, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg
| Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / / Sandy Weinberg |
| Autore | Weinberg Sandy <1950-> |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2011 |
| Descrizione fisica | 1 online resource (296 p.) |
| Disciplina | 615.1068/1 |
| Soggetto topico |
Medical instruments and apparatus industry - United States - Cost control
Medical instruments and apparatus - Inspection - United States Pharmaceutical industry - United States - Cost control Pharmaceutical industry - Inspection - United States |
| ISBN |
1-118-00227-X
1-283-02560-4 9786613025609 0-470-93350-X 0-470-93351-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Controlling regulatory costs -- Clear operation definitions of requirements -- Pre-regulatory audits -- Quality by design -- Outsourcing -- Electronic submissions -- Emea/fda coordination -- Managing FDA inspections -- Risk assessment -- Cases -- Cost containment analysis -- Managing regulation in times of chaos -- International regulation -- Cost contained regulatory compliance. |
| Record Nr. | UNINA-9910827252303321 |
|
Weinberg Sandy <1950->
|
||
| Hoboken, N.J., : John Wiley & Sons, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidebook for drug regulatory submissions [[electronic resource] /] / Sandy Weinberg
| Guidebook for drug regulatory submissions [[electronic resource] /] / Sandy Weinberg |
| Autore | Weinberg Sandy <1950-> |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley, c2009 |
| Descrizione fisica | 1 online resource (392 p.) |
| Disciplina |
344.7304/233
344.7304233 |
| Soggetto topico |
Drugs - Law and legislation - United States
Drug approval - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-282-02803-0
9786612028038 0-470-45618-3 0-470-45617-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Ten rules for drug regulatory submissions -- FDA meeting requests -- Orphan-drug applications -- Investigational new drug applications (INDs) -- New drug applications (NDAs) -- 505(b)2 new drug applications (NDAs) -- Abbreviated new drug applications (ANDAs) -- Annual reports -- International submissions / Carl A. Rockburne -- Future issues in regulatory submissions. |
| Record Nr. | UNINA-9910145952203321 |
|
Weinberg Sandy <1950->
|
||
| Hoboken, N.J., : John Wiley, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidebook for drug regulatory submissions [[electronic resource] /] / Sandy Weinberg
| Guidebook for drug regulatory submissions [[electronic resource] /] / Sandy Weinberg |
| Autore | Weinberg Sandy <1950-> |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley, c2009 |
| Descrizione fisica | 1 online resource (392 p.) |
| Disciplina |
344.7304/233
344.7304233 |
| Soggetto topico |
Drugs - Law and legislation - United States
Drug approval - United States |
| ISBN |
1-282-02803-0
9786612028038 0-470-45618-3 0-470-45617-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Ten rules for drug regulatory submissions -- FDA meeting requests -- Orphan-drug applications -- Investigational new drug applications (INDs) -- New drug applications (NDAs) -- 505(b)2 new drug applications (NDAs) -- Abbreviated new drug applications (ANDAs) -- Annual reports -- International submissions / Carl A. Rockburne -- Future issues in regulatory submissions. |
| Record Nr. | UNINA-9910829813403321 |
|
Weinberg Sandy <1950->
|
||
| Hoboken, N.J., : John Wiley, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidebook for drug regulatory submissions / / Sandy Weinberg
| Guidebook for drug regulatory submissions / / Sandy Weinberg |
| Autore | Weinberg Sandy <1950-> |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley, c2009 |
| Descrizione fisica | 1 online resource (392 p.) |
| Disciplina | 344.7304/233 |
| Soggetto topico |
Drugs - Law and legislation - United States
Drug approval - United States |
| ISBN |
1-282-02803-0
9786612028038 0-470-45618-3 0-470-45617-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Ten rules for drug regulatory submissions -- FDA meeting requests -- Orphan-drug applications -- Investigational new drug applications (INDs) -- New drug applications (NDAs) -- 505(b)2 new drug applications (NDAs) -- Abbreviated new drug applications (ANDAs) -- Annual reports -- International submissions / Carl A. Rockburne -- Future issues in regulatory submissions. |
| Record Nr. | UNINA-9910876553203321 |
|
Weinberg Sandy <1950->
|
||
| Hoboken, N.J., : John Wiley, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||