Online Regulatory Affairs Courses in India with Placement | Global Pharma Part 2

Learn Regulatory Affairs Courses Online from industry experts with 24+ years of experience in Clinical Research & Pharmaceutical Regulatory Affairs. Our online Regulatory Affairs Courses cover all the aspects like understanding clinical research, design of trials, Safety Reporting, ETC.

Beginner 5(1 Ratings) 10 Students enrolled English
Created by Vaishali Deshpande
Last updated Mon, 01-Apr-2024
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Course overview


You want to upgrade your skills and start career in ever growing regulatory affairs industry then this course is perfect for you!

Start learning Regulatory Affairs to start your career in most growing field of Pharma & life-Science Industry!

Either you're completely brand new to Regulatory Affairs, or you've played around it but want to get more comfortable with Regulatory Affairs. Either way, this course will be great for you.

Regulatory Affairs is the #1 field of Pharma & life-Science Industry. This full course is the best way to learn how to implement it.

What makes me qualified to teach you?

My name is Mrs Deshpande and I've been in the Regulatory Affairs for over a Two decade. Plus I'm the creator of some of the most popular online courses - with over 2000+ students like these ones:

Awesome course, easy to follow! – Radha Jaiswal

Your course is amazing, so I can say that I am learning a lot. Your English is very easy to understand ( I'm from Brazil). Thanks for sharing your amazing knowledge. – Santosh Chame

My Promise to You

I'll be here for you every step of the way. If you have any questions about the course content or anything related to this topic, you can always post a question in the course or send me a direct message. 

I want to make this the best course on Regulatory Affairs. So if there is any way I can improve this course, just tell me and I'll make it happen.

What is this Regulatory Affairs course all about?

In this complete guide to Regulatory Affairs, you'll not only learn all of the topics and segments of Regulatory Affairs, but also how to implement in real Industry so that you can crack any interview and start your career with a bang.

This course will cover everything you need to know to start your career, including:

·         Basics in Clinical Research

·         Drug Development Process

·         Good Clinical Practice (GCP) – ICH E6

·         Protocol Designing

·         Introduction to Regulatory Affairs

·         Regulatory Bodies

·         Design of trials

·         Application and Approvals

·         Safety Reporting 

By the end of this course, your confidence as a Clinical Researcher  will soar. You'll have a thorough understanding of Regulatory Affairs  domain for fun or as a career opportunity.

Go ahead and click the enroll button, and I'll see you in lesson 1!

What will i learn?

  • Knowledge of Regulatory Affairs industry
  • You will be job ready for Regulatory Affairs domain
  • Basics of Clinical Research and its Terminologies
  • Stake holders of Clinical Research
  • What is the career pathway in Regulatory Affairs
  • Process of drug development and understand different clinical trials phases
  • In depth study of how clinical trial are conducted along with some case studies.
  • Study of Good Clinical Practices
  • Will be gaining profound knowledge of informed consent
  • Will look at the purpose of essential document requirements
  • Clinical Data Management
Requirements
  • Ideally who has completed their graduation in science, pharmacy or ailed branch also who are interested in medicine field
Curriculum for this course
32 Lessons 06:25:14 Hours
Design of Trials
8 Lessons 02:25:49 Hours
  • CRF_Design_2
    00:26:16
  • Introduction Medical Writting
    00:14:01
  • Drafting a study protocol
    00:30:56
  • Study Design
    00:27:58
  • Informed Consent
    00:31:53
  • Trial Master File
    00:08:01
  • E Trial Master File
    00:06:44
  • Design of Trial- Notes
    .
Application and Approvals
5 Lessons 01:32:24 Hours
  • Purpose of QA Documentation
    00:26:59
  • Responsibilities of Quality Functions
    00:13:24
  • Application of Permission
    00:15:29
  • Approval of Clinical Trial
    00:13:13
  • Medical Devices
    00:23:19
Safety Reporting
12 Lessons 01:15:23 Hours
  • Adverse Event Reporting
    00:22:38
  • Recording of Event
    00:11:15
  • Medical Management of Adverse Events
    00:09:43
  • Handling Death
    00:04:22
  • Unblinding of Drug
    00:02:47
  • Clinical Safety and Pharmacovigilance
    00:24:38
  • E2A- Clinical Safety and Data Management
    .
  • Media 436
    .
  • Naranjo Assessment
    .
  • Order and Formulate to Determine the Quantum
    .
  • SAE Reporting
    .
  • Safety Reporting- Quiz
    00:00:00
Privacy and Confidentiality
7 Lessons 01:11:38 Hours
  • Privacy and Confedentiality
    00:14:44
  • HIPPA
    00:17:30
  • Informed Consent Privacy
    00:04:04
  • IRB's Role in Protecting Privacy
    00:09:06
  • Data Protection
    00:26:14
  • References Privacy and confidentiality
    .
  • MCQs Privacy and confidentiality
    .
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About instructor

Vaishali Deshpande

90 Reviews | 780 Students | 15 Courses
Student feedback
5
1 Reviews
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Reviews

  • Minal Sonule
    Great learning platform & live sessions are also helpful for interview preparation.
22000 Rs 16000 Rs
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