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Benefit-Risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-Making and Effective Communication / / by James Leong, Sam Salek, Stuart Walker
| Benefit-Risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-Making and Effective Communication / / by James Leong, Sam Salek, Stuart Walker |
| Autore | Leong James |
| Edizione | [1st ed. 2015.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015 |
| Descrizione fisica | 1 online resource (326 p.) |
| Disciplina |
306
353998 610 |
| Soggetto topico |
Pharmacy
Medicine - Research Drug Safety and Pharmacovigilance Quality of Life Research |
| ISBN | 3-319-15805-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Prologue -- Preface -- Overview -- Approaches to utilising decision-making framework -- Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities -- Development of a universal benefit-risk framework and template -- Implementation of the benefit-risk assessment template by mature agencies -- Implementation of the benefit- risk summary template by a maturing agency: A case study -- Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada -- Conclusions and future directions -- References. |
| Record Nr. | UNINA-9910300234003321 |
Leong James
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| Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Pharmaceutical Regulatory Environment : Challenges and Opportunities in the Gulf Region / / by Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
| Pharmaceutical Regulatory Environment : Challenges and Opportunities in the Gulf Region / / by Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek |
| Autore | Al-Essa Reem K |
| Edizione | [1st ed. 2015.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015 |
| Descrizione fisica | 1 online resource (246 p.) |
| Disciplina |
610
613 614 615.1 |
| Soggetto topico |
Public health
Chemotherapy Public Health Pharmacotherapy |
| ISBN | 3-319-17590-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Overview of Medicines Regulatory Systems in the Gulf Region -- 2. The Regulatory Review Process in the Gulf Region -- 3. Regulatory Review Times in the Gulf Region -- 4. Quality Measures in the Gulf Regulatory Practices -- 5. The Current Status of the Common Technical Document -- 6. The Current Status of Drug Safety and Pharmacovigilance -- 7. The Centralized Regulatory Review in the Gulf Region -- 8. The Gulf States Assessment and Experience With the Centralised Procedure -- 9. The Pharmaceutical Companies Assessment and Experience With the Centralised Procedure -- 10. Proposal For an Improved Centralized Regulatory System -- 11. The Strategic Planning Process of the GCC Regulatory Authorities: Barriers And Solutions -- 12. The Regulatory Dilemma in the Gulf Region: The Way Forward. |
| Record Nr. | UNINA-9910300213903321 |
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Al-Essa Reem K
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| Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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