Writing the DSUR - Couverture souple

Selim, Hafez

Couverture souple

ISBN 13 : 9798235528840

Editeur : Selim Medical Press, 2026

Synopsis

Every investigational drug in clinical development produces one document a year that asks a single question: given everything learned this year, is it still reasonable to expose people to this drug in trials? That document is the Development Safety Update Report (DSUR), and the judgment it depends on is usually learned the slow way.

Writing the DSUR is a practical, section-by-section manual for writing ICH E2F Development Safety Update Reports that regulators can trust. It goes beyond what the guideline requires to teach the judgment behind a strong report: deciding what the reporting period actually changed, reading imbalances in blinded data without unblinding, writing an overall safety assessment that interprets rather than repeats, keeping the summary of important risks honest from year to year, and running the process so the report lands inside the 60-day window.

Inside you will find:

• Seventeen chapters in four parts: Foundations, the Data Layer, the Judgment Layer, and Craft and Delivery
• Section blueprints showing the logic, messaging and level of detail each DSUR section needs at each stage of development
• Practical guidance on reference safety information and expectedness, exposure estimates, and SAE listings and tabulations
• Regional requirements and submission, quality control, inspection readiness and responding to regulator questions
• A dedicated chapter for executive reviewers who sign off the report
• Fictional case files with an answer key, a section-level QC checklist, a timeline planner and RACI template, a glossary, and do's and don'ts at a glance
• Free companion templates and a fully worked mock DSUR

Written by Dr. Hafez Selim, MD, PhD, a physician-scientist with long experience in drug and medical device safety, for safety physicians, safety scientists, clinical development leads, medical writers and regulatory affairs professionals in pharma and biotech.

Détails de l'édition

• Éditeur: Selim Medical Press
• Date d'édition: 2026
• Langue: anglais
• ISBN 13: 9798235528840
• Reliure: Tapa blanda
• Nombre de pages: 294
• Coordonnées du fabricant: non disponible
• Personne responsable: gpsr@libri.de; gpsr@libri.de; ; Europaallee 1; Bad Hersfeld; 36244; Allemagne