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Record Nr. |
UNINA9910830636003321 |
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Autore |
Orleans-Lindsay Justina |
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Titolo |
Pharmacovigilance medical writing [[electronic resource] ] : a good practice guide / / Justina Orleans-Lindsay |
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Pubbl/distr/stampa |
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Chichester, West Sussex, U.K., : John Wiley & Sons Inc., 2012 |
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ISBN |
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1-118-30206-0 |
1-280-79269-8 |
9786613703088 |
1-118-30191-9 |
1-118-30190-0 |
1-118-30205-2 |
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Edizione |
[2nd ed.] |
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Descrizione fisica |
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1 online resource (287 p.) |
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Disciplina |
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Soggetti |
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Drug monitoring |
Communication in medicine - Methodology |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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Pharmacovigilance medical writing : an overview across the drug development process -- Pharmacovigilance medical writing for clinical trials -- Pharmacovigilance medical writing for CTD submissions -- Pharmacovigilance medical writing in risk evaluation & management -- Pharmacovigilance medical writing for marketed products -- The Ad-Hoc safety review & response to questions document -- The rest of the world. |
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Sommario/riassunto |
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Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document |
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