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Global Pharma Drug Regulatory Affairs course

9.99

Last updated on October 12, 2021 17:41

Description

What you’ll learn

  • Basic concepts Pharma Regulatory Affairs
  • Advanced Regulatory Affairs
  • How Regulatory Authorities Regulates Drug product
  • Career in Regulatory Affairs
  • Job opportunities
  • eCTD & CTD Structure
  • Dossier Preparation & Submission
  • Drug master file
  • Submission of Drug Master File
  • eCTD Modules
  • General Demonstration of eCTD Software
  • General demonstration of eValidator


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If you are looking for Pharma Regulatory affairs course to start career as Regulatory Professional without paying huge amount or money then you are on right platform.

This course is for starting career in Regulatory affairs with certificate of completion.

Complete the course as per your free time as life time access is available.

If you are paying more than 5k INR or $15 for private institute/academy then you are in loss.

Please compare the course description and amount you are paying for such course.

Course Details:

The Pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices

Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. …

Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug.

So, this online course helps Pharmacy Students and Professionals to build their knowledge and skills towards career in Regulatory Affairs.

Regulatory course prepares students to be skilled in the field of global regulatory affairs, and enables existing regulatory affairs professionals to refine and update their knowledge of global regulatory affairs statutes and practices.

Prepare to play a pivotal role in managing the regulatory activities necessary to bring drugs and medical products to market.

Contents of this course :-

1. Basic Regulatory Introduction

2. Career and opportunities in RA

3. Objectives in RA Profession

4. Websites and Usage

5. Intoduction to ICH Guidelines

6. Basic general information about DMF (Drug Master File)

7. DMF preparation and submission

CTD & eCTD

8. Module 1

9. Module 2

10. Module 3

11. Module 4

12. Module 5

13. eCTD software demo and eValidation

Announcement

In this Advanced RA course the Detailed Practical and Theriotical aspects of Regulatory affairs can be learn in this course.

Like :-

Basics of Regulatory affairs

ICH, DMF, ASMF, CTD, eCTD, CTD structure, 1-5 Modules of CTD.

Basic Demonstration of eCTD software & eValidator (Lorenz Docubridge) 21CFR complied.

Drug Product Development, Documents Required for filling.

Preperation & Submission of CTD, eCTD, DMF, Filling of Applications (IND, NDA, ANDA, BLA).

Other miscellaneous Aspects in RA.

Who this course is for:

  • Pharmaceutical industry employees
  • Pharmacy Students & Pharma Professionals
  • Chemistry students
  • Science Graduates
  • Diploma in pharmacy
  • Pharma professionals

Course content

  • Course Contents
  • Drug Master File
  • Common Technical Documents
  • New Drug Approval (NDA) & Abreviated new drug application (ANDA)

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