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Clinical & Nonclinical Studies (M4, M5 & M2 of CTD) for Regulatory Personnel Training Course

The course goal is to provide you with the right skills to handle properly pharmaceutical CTD files in Modules 4, ... Show more

Instructor

Dr. Samer Sowidan

On Individual or Group Purchases to This Course, You Get Lifetime Access

Clinical & Nonclinical Studies (M4, M5 & M2 of CTD) Course

Dive into the world of regulatory science with “Clinical & Nonclinical Studies: Mastering M4, M5, & M2 of CTD”, an engaging self-paced course offered exclusively by Upbeat Consult on YouLearnMe.com.

This course unravels the complexities of the Common Technical Document (CTD), focusing on its critical modules:

M4 (Nonclinical Study Reports): Learn how to present pharmacology, toxicology, and other preclinical data effectively to support drug safety and efficacy.
M5 (Clinical Study Reports): Understand the structure and significance of clinical study reports, including trial design, statistical analyses, and patient safety evaluations.
M2 (Common Technical Document Summaries): Master the art of summarizing nonclinical and clinical data to create compelling and compliant dossiers for global submissions.

Course Objectives:

· Participants will learn how to go through & review Module 4 for Originators.

· Participants will be able to understand the drug non-clinical studies requirements with examples according to the CTD guidelines

· Participants will learn how to go through & review Module 5 for Originators.

· Participants will be able to understand the drug clinical studies requirements with examples according to the CTD guidelines

· Participants will go through Model 2 for the clinical and nonclinical summaries and will understand what they contain and how they are written

The passing Mark to get a Certificate is 50 / 100

· After you complete the course, go to my certificate section to download your certificate

· In order to get your first name and last name on the certificate, please add or include those in your profile with correct spelling and as you want them to appear on the certificate. i.e. go to my profile to add your first or last name. if you already included them from the initial log-in, then no need.

Clinical & Nonclinical Studies (M4, M5 & M2 of CTD) Training Course Overview

tudies (M4, M5 & M2 of CTD) Training Course Overview

Course materials

References & Recommended Reading.pdf

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نموذج تقييم المحتوى العلمي عربي.pdf

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Why the course contains no separate lessons?

The course is designed with a technology called scorm package where all the lessons are contained in the same course screen. You press the menu button at the top right section of the screen where a drop menu pop up and all the lessons with the case studies and tests will appear and you can select directly to go a specific lesson if you don't want to watch the lessons sequentially

Will there be a Certificate at the end of the course?

YES. there will be after getting at least 50 marks in all tests of the modules

What about the assessment questions of the course?

Every course is composed of different Modules. All the modules have assessment questions. You must answer all of them and get a cumulative grade of at least 50% to get the Certificate of completion. The assessment questions are on the sort of multiple choices. Each module has 10 questions

This is the latest updated version of the course. Any updates on the course or specific announcements (e.g., Tasks, Assignments, …etc.) will be placed here

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