Pharma Drug Regulatory Affairs Certificate Course - DRA 2025
DRA, Orange book, USFDA, eCTD, CTD, INDA, NDA, ANDA, DMF, ICH, Software Demo, RA Jobs, Quiz, Pharma Skills, Updated 2024
3.87 (782 reviews)
7,740
students
7.5 hours
content
Jan 2025
last update
$64.99
regular price
What you will learn
Basic concepts Pharma Regulatory Affairs
Advanced Regulatory Affairs
How Regulatory Authorities Regulates Drug product
Career in Regulatory Affairs
Job opportunities
eCTD & CTD Structure
eCTD Modules
Dossier Preparation & Submission
Drug master file
Submission of Drug Master File
General Demonstration of eCTD Software
General demonstration of eValidator
Registration Process
ICH Guidelines
USFDA regulations: INDA
INDA concept
New drug development
FDA meetings
IND Review process
Market Approvals
Online ESG (Electronic Submission Gateway) tool
Screenshots
Related Topics
3576633
udemy ID
10/18/2020
course created date
9/7/2021
course indexed date
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course submited by