Category: Tutorials
- views: 66
- date: 27 October 2026
- posted by: AD-TEAM
Microsoft 365 Copilot – The Full Guide
Published 9/2026
Created by Nikolai Schuler, Jagger Bellagarda
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Level: All Levels | Genre: eLearning | Language: English | Duration: 73 Lectures ( 5h 41m ) | Size: 4.1 GB
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Category: Tutorials
- views: 76
- date: 27 October 2026
- posted by: 0nelove
Writing the DSUR: Development Safety Update Reports
Published 10/2026
MP4 | Video: h264, 1920x1080 | 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://rapidgator.net/file/b8c8bb61c29afc86c0dd7e91487b64bb/Writing_the_DSUR_Development_Safety_Update_Reports.part3.rar.html
https://rapidgator.net/file/390cdb8285f980ba385995df57886e33/Writing_the_DSUR_Development_Safety_Update_Reports.part2.rar.html
https://rapidgator.net/file/df3daed43faa7695fee1d34559ced534/Writing_the_DSUR_Development_Safety_Update_Reports.part1.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
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Category: Apps (SEO/Marketing/Design)
- views: 73
- date: 27 October 2026
- posted by: DrZero
Windows (x64) | File Size: 157 MB
Cisdem PDF Compressor - the smartest compressor to reduce PDF file size! Cisdem PDF Compressor can reduce PDF file size up to 90% and keep best possible quality. The preset and custom filters allow you to decide the size and quality of your PDFs.
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Category: Apps (SEO/Marketing/Design)
- views: 85
- date: 27 October 2026
- posted by: DrZero
Windwos (x64) | File Size: 108 MB
Cisdem PDF Password Remover an easy-to-use PDF password remover to help users unlock password protected PDFs, removing restrictions on opening, printing, editing and copying instantly. No quality loss of original files.
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Category: Apps (SEO/Marketing/Design)
- views: 43
- date: 27 October 2026
- posted by: DrZero
Windows (x64) | File size: 740 MB
LightBurn is layout, editing, and control software for your laser cutter.
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Category: Apps (SEO/Marketing/Design)
- views: 43
- date: 27 October 2026
- posted by: DrZero
Windows (x64) | File size: 740 MB
LightBurn is layout, editing, and control software for your laser cutter.
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Category: Apps (SEO/Marketing/Design)
- views: 35
- date: 27 October 2026
- posted by: DrZero
File Size: File Size: 3.1 GB (In Total)
The Graphics Creator 8 - Create your own graphics in minutes without ANY design skills or a big budget! Grab attention with stunning graphics... fast! Search from hundreds of thousands of high-quality stock photos and videos. And much more!
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Category: Apps (SEO/Marketing/Design)
- views: 33
- date: 27 October 2026
- posted by: DrZero
File size: 15.1 MB
A Better Finder Attributes is the ultimate file-tweaking tool for OS X. It combines photo-shooting date and file date changing along with a few unique tricks of its own.
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Category: Apps (SEO/Marketing/Design)
- views: 21
- date: 27 October 2026
- posted by: DrZero
Language: Multilingual | File Size: 38.2 MB
Cisdem PDF Compressor - the smartest compressor to reduce PDF file size! Cisdem PDF Compressor can reduce PDF file size up to 90% and keep best possible quality. The preset and custom filters allow you to decide the size and quality of your PDFs.
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Category: Apps (SEO/Marketing/Design)
- views: 41
- date: 27 October 2026
- posted by: DrZero
File Size: 29.9 MB
Cisdem PDF Password Remover an easy-to-use PDF password remover to help users unlock password protected PDFs, removing restrictions on opening, printing, editing and copying instantly. No quality loss of original files.
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Category: Apps (SEO/Marketing/Design)
- views: 32
- date: 27 October 2026
- posted by: DrZero
File size: 149 MB
There's no secret behind it – keeping your PC and OS free of clutter, temporary files and accumulated junk can go a long way in terms of maintaining it running smoothly and in a performant manner. This is where apps such as JWIZARD Cleaner can prove to be useful.
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Category: Apps (SEO/Marketing/Design)
- views: 20
- date: 27 October 2026
- posted by: DrZero
Languages: English | File size: 158 MB
VectorStyler is an advanced illustration and drawing software. Create illustrations, logos, icons, drawings, typography, vector art for screen, print and web.
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Category: Apps (SEO/Marketing/Design)
- views: 39
- date: 27 October 2026
- posted by: DrZero
File Size: 175 MB
Veeam Agent for Microsoft Windows provides a simple solution for backing up Windows-based desktops and laptops/notebooks. With Veeam Agent for Microsoft Windows Fee, you can easily back up your computer to an external hard drive or NAS (network-attached storage) share. And if your system crashes, hard drive fails, or a file gets corrupted or accidentally deleted, you can recover what you need in minutes - like it never even happened.
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Category: Apps (SEO/Marketing/Design)
- views: 40
- date: 27 October 2026
- posted by: DrZero
File size: 9.71 MB
Remo Repair PSD is a complete repair utility that will securely fix Photoshop PSD & PDD image files that are corrupt due to various reasons like application fault / freeze, power surge, virus attack etc. It uses highly advanced repair technique and provides useful features, which makes it the best option for fixing PSD files that refuses to open.
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Category: Apps (SEO/Marketing/Design)
- views: 16
- date: 27 October 2026
- posted by: DrZero
File size: 156 MB
WinMerge is a Windows tool for visual difference display and merging, for both files and directories. It is highly useful for determining what has changed between file versions, and then merging those changes. WinMerge has Unicode support, Flexible syntax coloring editor, Visual SourceSafe integration, and Windows Shell integration. Regexp filtering for filenames and lines. Side-by-side line difference and highlights differences inside lines. A file map shows the overall file differences in a location pane. The user interface is translated into several languages.
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Category: Apps (SEO/Marketing/Design)
- views: 20
- date: 27 October 2026
- posted by: DrZero
File size: 34 MB
There's no secret behind it – keeping your PC and OS free of clutter, temporary files and accumulated junk can go a long way in terms of maintaining it running smoothly and in a performant manner. This is where apps such as JWIZARD Cleaner can prove to be useful.
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Category: Apps (SEO/Marketing/Design)
- views: 45
- date: 27 October 2026
- posted by: DrZero
File size: 1.15 GB
Pazu All-In-One Music Converter for Windows allows you to easily download Apple Music/Spotify/amzon Music/YouTube Music/TIDAL/Deezer/Pandora to MP3/M4A/AAC/FLAC/WAV/AIFF.
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Category: Tutorials
- views: 25
- date: 27 October 2026
- posted by: AD-TEAM
Revit 2025: Essential Training for Architecture
Released: 4/19/2024
Duration: 16h 54m | .MP4 1280x720, 30 fps(r) | AAC, 48000 Hz, 2ch | 7.77 GB
Genre: eLearning | Language: English
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Category: Apps (SEO/Marketing/Design)
- views: 18
- date: 27 October 2026
- posted by: DrZero
Windows (x64) | File size: 1.82 GB
AquaSoft Stages is a tool for professionals, photographers, animators, and ambitious advanced users who require maximal functionality from their software and want to control every moment of their project precisely.
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Category: Apps (SEO/Marketing/Design)
- views: 17
- date: 27 October 2026
- posted by: DrZero
File size: 730 MB
We have long overtaken the topic of photo presentation. For years, our programs have been able to do much more than the name SlideShow could express. Along with the new version 13, the new name was changed to AquaSoft Vision. Vision is thus the direct successor to the popular AquaSoft slide show program. AquaSoft SlideShow Premium becomes AquaSoft Photo Vision.
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Category: Apps (SEO/Marketing/Design)
- views: 27
- date: 27 October 2026
- posted by: DrZero
File size: 730 MB
We have long overtaken the topic of photo presentation. For years, our programs have been able to do much more than the name SlideShow could express. Along with the new version 13, the new name was changed to AquaSoft Vision. Vision is thus the direct successor to the popular AquaSoft slide show program. AquaSoft SlideShow Premium becomes AquaSoft Photo Vision.
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Category: Apps (SEO/Marketing/Design)
- views: 18
- date: 27 October 2026
- posted by: DrZero
Windows (x64) | File size: 722 MB
We have long overtaken the topic of photo presentation. For years, our programs have been able to do much more than the name SlideShow could express. Along with the new version , the new name was changed to AquaSoft Vision. Vision is thus the direct successor to the popular AquaSoft slide show program. AquaSoft SlideShow Ultimate becomes AquaSoft Video Vision.
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Category: Apps (SEO/Marketing/Design)
- views: 36
- date: 27 October 2026
- posted by: DrZero
Windows (x64) | File size: 734 MB
AquaSoft Stages is a tool for professionals, photographers, animators, and ambitious advanced users who require maximal functionality from their software and want to control every moment of their project precisely.
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Category: Apps (SEO/Marketing/Design)
- views: 31
- date: 27 October 2026
- posted by: DrZero
File size: 2.19 GB
Make every photo better with Zoner Photo Studio X! Your Lightroom® and Photoshop® alternative. ZPS X is the most universal photo software there is. RAW processing. Layer support. Presets. Retouching tools. Video editing. Cataloging. It's all there.
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Category: Apps (SEO/Marketing/Design)
- views: 36
- date: 27 October 2026
- posted by: DrZero
File size: 3.82 MB
WinRAR is a powerful archive manager for Windows. This is a powerful compression tool with many integrated additional functions to help you organize your compressed archives. It can backup your data and reduce size of email attachments, decompress RAR, ZIP and other files downloaded from Internet and create new archives in RAR and ZIP file format. The archiver puts you ahead of the crowd when it comes to compression.
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Category: Apps (SEO/Marketing/Design)
- views: 27
- date: 27 October 2026
- posted by: DrZero
Windows (x64) | File size: 119 MB
In the spirit of Halloween JixiPix presents a fun way to create spooktacularly creepy scenes with your photo. Start by selecting an eerie scene from the included presets or hit the randomize button for unlimited frightful toning effects. These dark thrilling effects combined with haunted Halloween objects are sure to send shivers down your spine leaving you screaming . for more. When you're done conjuring your ghostly scenes, share your Halloween spirit with your friends. You can even add a HAPPY HAUNTING from the library of objects then send your spooky creations as an e-card. If you love Halloween as much as the folks at JixiPix, it will be a sweet addition to your bag of FX tricks.
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Category: Apps (SEO/Marketing/Design)
- views: 27
- date: 27 October 2026
- posted by: DrZero
Windows (x64) | File size: 104 MB
Hand Tint Pro supplies everything you need—color palettes, paper and smart brushes—for creating beautiful and timeless hand painted photography. Like all art forms, preparing a good base for hand coloring is like stretching a canvas for painting, so every image placed in the app is stripped of color and transformed into a classic Black & White, a dreamy Luminescent or an aged Vintage photo we call a Background Effect.
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Category: Apps (SEO/Marketing/Design)
- views: 19
- date: 27 October 2026
- posted by: DrZero
Windows (x64) | File size: 213 MB
Introducing Pastello, a brand-new companion app to JixiPix's Impresso Pro. Pastello takes you back in time to the 15th century. Away from brushes and large strokes and into the realm of dry media with color that is both brilliant and subtle. The "Dry color method" made famous by Leonardo da Vinci is so powerful in its simplicity and beauty with its black and red chalk and yellow pastel highlights. Later, artists would paint charming portraits in a smooth heavily blended fashion.
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Category: Apps (SEO/Marketing/Design)
- views: 18
- date: 27 October 2026
- posted by: DrZero
File size: 8.14 MB
Powerful USB Encryption Tool! iSumsoft USBCode is a powerful and easy-to-use USB encryption tool for encrypting, decrypting, locking and unlocking USB drives.
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Category: Apps (SEO/Marketing/Design)
- views: 21
- date: 27 October 2026
- posted by: DrZero
File size: 111 MB
Create personalized photo collages with flexible layouts, your own text, and the right size.
The ocean view, dinner together, the photo where everyone is laughing: Some memories simply won't fit into a single picture. With Ashampoo Photo Collage, you bring your photos together in a personal collage. Choose the size, customize the photo grid, and add colors, spacing, and your own text. Turn your photos into a little vacation story, a look back at a family celebration, or a collection of your favorite pictures.
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