Writing the DSUR: Development Safety Update Reports
Published 10/2026
MP4 | Video: h264, 1920×1080 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 8h 48m | Size: 2.98 GB
Master ICH E2F like a safety physician: scope, exposure, the Section 18 assessment, important risks, QC and sign-off
What you’ll learn
Set the DIBD, reporting period and data lock point, and plan a DSUR backward from day 60 so that most of the work is done before the lock
Choose and document the correct reference safety information and reconcile expedited reports against the DSUR listings
Estimate cumulative exposure in blinded trials without unblinding, with a method another reader can reproduce
Build SAR line listings and cumulative SAE tabulations that reconcile with the clinical database
Write a Section 18 overall safety assessment that interprets instead of repeating, using a five-step method for every issue
Keep the Summary of Important Risks honest and aligned with the IB, protocols, consent forms and any RMP
Write a benefit-risk statement, conclusions and an Executive Summary that tell one consistent story
Run two-layer QC, keep an inspection-ready DSUR file and answer regulator questions with confidence
Handle the first and final DSUR, programs on hold, pediatric and advanced therapy programs, and DSUR-PBRER alignment
Review and sign off a DSUR as an executive reviewer in about 30 minutes, focusing on the judgment rather than the data
Requirements
A working knowledge of clinical trials and of individual case safety reporting (what an SAE and a SUSAR are). The course does not teach MedDRA or ICSR processing.
No previous DSUR experience is needed. If you have written one, you will learn why reviewers made the comments they made.
Recommended: keep a copy of the ICH E2F guideline at hand (free from the ICH website).
Description
Every investigational drug produces one document a year that answers a single question: given everything we learned this year, is it still reasonable to expose people to this drug in clinical trials? That document is the Development Safety Update Report (DSUR).
ICH E2F tells you what goes into each of the twenty sections. It does not teach the judgment the report depends on: how to decide what the reporting period actually changed, how to read an imbalance in blinded data without unblinding it, how to write an overall safety assessment that interprets instead of repeating, how to keep a list of important risks honest from year to year, and how to land the whole report inside sixty days without the review cycle collapsing.
This course teaches that judgment. It is built on my book Writing the DSUR and on years of writing and reviewing periodic safety reports as a safety physician. It follows the life of a DSUR in four parts
-Foundations: what the DSUR is for, who reads it, scope decisions, and a process that finishes on time.
-The data layer: reference safety information and expectedness, exposure, SAE listings and tabulations, and sources beyond your own trials.
-The judgment layer: actions taken, late-breaking information, significant trial findings, the Section 18 overall safety assessment, the summary of important risks, benefit-risk, conclusions and the Executive Summary.
-Craft and delivery: writing craft, regional overlays and submission, quality control, inspection readiness, regulator questions, special situations, and executive review and sign-off.
You will learn through six fictional programs that recur throughout the course, each chosen to expose a different DSUR problem: a first-in-human kinase inhibitor, a blinded Phase 3 antibody, a marketed anticoagulant in a new indication, an adjuvanted vaccine in healthy adults, a gene therapy in long-term follow-up, and a partnered small molecule. You will see weak paragraphs rewritten into strong ones, and you will practice the decisions yourself.
What’s included: 72 narrated video lectures (about 9 hours), a quiz at the end of every section, a hands-on assignment per section with an instructor model answer, a 30-question final practice test, and downloadable slides. Free templates and tools (scope record, timeline back-planner, review card, case files and an annotated mock DSUR) are available free in the companion repository, linked inside the course.
By the end you will be able to write a DSUR that takes less effort to produce, fewer rounds to review, and says something clear about the drug you are developing.
Disclaimer: this course is educational. It does not replace ICH E2F, regional regulations, regulator guidance or your organization’s procedures, and it is not legal or regulatory advice. All products, trials, subjects and data in the examples are fictional. Regional requirements are stated as of the dates given in the course; check the companion repository’s Updates page for later changes.
Lecture scripts and practice questions were drafted with AI assistance from the instructor’s own book, and the lecture narration uses a synthetic (AI-generated) voice.
Who this course is for
Safety physicians and drug safety scientists who write or own DSURs
Medical writers who assemble periodic safety reports and keep their sections consistent
Clinical development leads who contribute trial status and efficacy context and sign the report
Regulatory affairs professionals who submit DSURs and answer the questions they raise
Heads of safety, therapeutic area leads and safety committee members who review and sign DSURs
Pharmacovigilance professionals moving from post-marketing work into clinical development safety
Homepage
https://www.udemy.com/course/writing-the-dsur-development-safety-update-reports/
https://rapidgator.net/file/37a8cd81645f8814ab848fa685a177ee/Writing_the_DSUR_Development_Safety_Update_Reports.part4.rar.html
https://nitroflare.com/view/8D966A514477381/Writing_the_DSUR_Development_Safety_Update_Reports.part4.rar
https://nitroflare.com/view/38A72A2CFE9E760/Writing_the_DSUR_Development_Safety_Update_Reports.part3.rar
https://nitroflare.com/view/E6B3B737F7482DF/Writing_the_DSUR_Development_Safety_Update_Reports.part2.rar
https://nitroflare.com/view/73FAA32E1A4F368/Writing_the_DSUR_Development_Safety_Update_Reports.part1.rar