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 2025

4.25 (810 reviews)

Udemy

platform

English

language

Science

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

Course Gallery

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Comidoc Review

Our Verdict

The Pharma Drug Regulatory Affairs Certificate Course - DRA 2025 offers extensive coverage of essential regulatory concepts and processes. However, improvements in presentation style and value-added explanations beyond mere slide readings would enhance learners' overall experience. The course may benefit from enhanced language proficiency or the addition of closed captions to ensure learners grasp complex topics seamlessly. Nevertheless, learners seeking resources on Pharma Regulatory Affairs could consider this course for its wealth of information and practical demos.

What We Liked

This course provides a comprehensive overview of various concepts critical to a career in Pharma Regulatory Affairs (DRA), including eCTD & CTD structure, dossier preparation, USFDA regulations, and ICH guidelines.
The course features valuable resources such as links, appendices, form-filling formats, and software demos that add context to the learning experience. Some learners found these resources helpful for their work.
A few reviewers appreciated the course's coverage of new terminologies and regulatory processes, enhancing their understanding and knowledge of Pharma Regulatory Affairs.
Section quizzes and a general eValidator demo have been praised for facilitating practical engagement in an otherwise text-heavy course.

Potential Drawbacks

Multiple reviewers expressed concerns about the monotonous presentation style, with slides being read word by word without adding value or engaging explanations.
The course could benefit from improved pronunciation and grammar to ensure clarity in the explanation of complex topics. Some learners struggled to comprehend certain sections due to language proficiency issues.
Some reviewers mentioned that too much information presented as text made the course less interesting, and that more examples would help illustrate core concepts better.
A few learners expressed disappointment with the instructor's failure to elaborate on important points or provide additional insights, suggesting that the content could be condensed to focus on critical topics.