Pharmacovigilance medical writing [[electronic resource] ] : a good practice guide / / Justina Orleans-Lindsay

• Autore: Orleans-Lindsay Justina
• 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.: 9910830636003321
• Lo trovi qui: Univ. Federico II