• Home
  • Our Services
  • Courses
    • Courses list
    • Courses Calender
  • About us
  • Blog
  • Contact us
    • Customer Satisfaction
Login / Register
0 items SAR  0
Menu
0 items SAR  0
Home Uncategorized Common Technical Document (CTD) for Registration of Human Drugs Online Training Course
Qualified Person form Pharmacovigilance (QPPV) SAR  3,277
Back to products
Qualified Person form Pharmacovigilance (QPPV) SAR  3,277
Sold out
Click to enlarge

Common Technical Document (CTD) for Registration of Human Drugs Online Training Course

SAR  1,380

Registeration Expired

Category: Uncategorized
Share:
  • Description
  • Reviews (0)
Description
COURSE AGENDA
Introduction to the Common Technical Document (CTD)
And ICH

·Overview On Regulatory Affairs System

·Background On the ICH Guidance And CTD

·Outline & basic Structure of CTD (Modules 1-5)

MODULE 1
Administrative and Product Information

·Outline of the contents of Module 1

·Tables of contents

·The summary OF Product Characteristics (SPC)

·Packaging, Labelling and PIL regulations

·Certificates Requirements

MODULE 2
Requirements of the summaries and Overview documents

·QUALITY overall summary (QOS)

·Non-Clinical SUMMARY AND TABULATE Summaries

·Non-clinical Overview

·Clinical overview

MODULE 3
Understanding Drug Substance:

·Starting AND The material in A CHEMICAL SYNTHESIS

·Data provision options for manufacturing and control including Master Files and Certificates of Suitability

Understanding drug substance:

·Control of drug substance

·Stability

·Common deficiencies

Understanding Drug Products

·Starting and other materials in drug formulation

·Pharmaceutical development: composition, functions, optimization & bioequivalence

·Manufacturing process

·In-process and finished product control

Understanding Drug Products

·Control of drug products

·Stability

·Common deficiencies

MODULE 4

Non-Clinical Study Reports

MODULE 5
Clinical Study Reports

·Clinical data requirements for efficacy and safety

·Clinical summary

·Bioequivalence

Reviews (0)

Reviews

There are no reviews yet.

Be the first to review “Common Technical Document (CTD) for Registration of Human Drugs Online Training Course” Cancel reply

Your email address will not be published. Required fields are marked *

Related products

Sold out

Qualified Person form Pharmacovigilance (QPPV)

Uncategorized
SAR  3,277
Registration Expired
Quick view
Sold out

Qualified Person form Pharmacovigilance (QPPV)

Uncategorized
SAR  3,277
Registration Expired
Quick view
Sold out

Advanced Module 3 Content for Biologics & Biosimilars

Uncategorized
SAR  6,200
Registration Expired
Quick view
Sold out

Qualified Person form Pharmacovigilance (QPPV)

Uncategorized
SAR  3,277
Registration Expired
Quick view
  • Location: Saudi Arabia, Reyad.
  • Phone Number
    (+966)920019011
  • Email
    info@mesned.com
Recent Posts
  • WhatsApp Image 2025-02-09 at 11.32.41_b6d0b3f8
    SIPHA 2025
    09/02/2025 No Comments
  • CPHI Brochhure 2024
    CPHI Middle East 2024 in Riyadh.
    09/02/2025 No Comments
Locations
  • Saudi Arabia
  • Jordan
  • Egypt
Sisters Companies
  • Mustanier for Health Training
  • ArabMed CRO
  • CalLab
  • Contact Us
Social Media
  • Linkedin
Copyright ©2024 Mesned All rights reserved. Developed by SIMS Creation
payments
Close
  • Home
  • Our Services
  • Courses
    • Courses list
    • Courses Calender
  • About us
  • Blog
  • Contact us
    • Customer Satisfaction
  • Login / Register
Shopping cart
Close
Sign in
Close

Lost your password?

No account yet?

Create an Account
  • العربية (Arabic)
  • English