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.
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.
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
8. Module 1
9. Module 2
10. Module 3
11. Module 4
12. Module 5
13. eCTD software demo and eValidation
In this Advanced RA course the Detailed Practical and Theriotical aspects of Regulatory affairs can be learn in this course.
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.
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