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Autore: | Orleans-Lindsay Justina |
Titolo: | Pharmacovigilance medical writing [[electronic resource] ] : a good practice guide / / Justina Orleans-Lindsay |
Pubblicazione: | Chichester, West Sussex, U.K., : John Wiley & Sons Inc., 2012 |
Edizione: | 2nd ed. |
Descrizione fisica: | 1 online resource (287 p.) |
Disciplina: | 615.4 |
615.7 | |
615/.4 | |
Soggetto topico: | Drug monitoring |
Communication in medicine - Methodology | |
Note generali: | Description based upon print version of record. |
Nota di bibliografia: | Includes bibliographical references and index. |
Nota di contenuto: | 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. |
Sommario/riassunto: | 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 preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the |
Titolo autorizzato: | Pharmacovigilance medical writing |
ISBN: | 1-118-30206-0 |
1-280-79269-8 | |
9786613703088 | |
1-118-30191-9 | |
1-118-30190-0 | |
1-118-30205-2 | |
Formato: | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione: | Inglese |
Record Nr.: | 9910141253603321 |
Lo trovi qui: | Univ. Federico II |
Opac: | Controlla la disponibilità qui |