Certificate Course in Drug Regulatory Affairs (DRA)
4.5 /5- Offered byUDEMY
Certificate Course in Drug Regulatory Affairs (DRA) at UDEMY Overview
Certificate Course in Drug Regulatory Affairs (DRA)
at UDEMY
Professional reputation building and career success enhancement through proper understanding of Drug Regulatory Affairs and related concepts
Duration | 3 hours |
Total fee | ₹3,520 |
Mode of learning | Online |
Credential | Certificate |
Certificate Course in Drug Regulatory Affairs (DRA) at UDEMY Highlights
Certificate Course in Drug Regulatory Affairs (DRA)
at UDEMY
- Full lifetime access
- 64 downloadable resources
- Earn a Certificate of completion from Udemy
- Comes with 30 days money back guarantee and full lifetime access
Read more
Certificate Course in Drug Regulatory Affairs (DRA) at UDEMY Course details
Certificate Course in Drug Regulatory Affairs (DRA)
at UDEMY
Who should do this course?
- For employees of Pharmaceutical Industry, Pharma entrepreneurs, and Pharma Consultants
- For Graduates, Postgraduates, PhD. Students (Pharmacy, PharmD, Science, Medical)
- For Anyone who is eligible and wants to make a career in Drug Regulatory Affairs
What are the course deliverables?
- Basic understanding and terminologies related to Dug Regulatory Affairs (DRA)
- Common Technical Document (CTD), Modules, ACTD Vs ICH-CTD
- Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (cGMP)
- Biologics License Application (BLA) and Purple Book
More about this course
- Basic Understanding and Terminologies related to DRA
- This course also contains a bonus course entitled "Meeting etiquettes" which will help to shape career in which the points that must be taken into consideration while attending/conducting meetings are covered
- This course will help to develop the ability to conduct regulatory intelligence and develop a regulatory strategic plan
- Discover how to navigate important websites including ICH Guidelines to find more relevant information
Certificate Course in Drug Regulatory Affairs (DRA) at UDEMY Curriculum
Certificate Course in Drug Regulatory Affairs (DRA)
at UDEMY
Introduction
Basic Understanding And Terminologies
Why Regulatory Affairs?
RA Objectives
Types of Companies Hiring RA Professionals
Qualities of RA Professional
Historical background of US Drug Law and Regulations
Major Agencies for Drug Regulations in USA
Drug Approval Process
New Drug Development-Preclinical Steps
Process of Investigational New Drug Application (INDA)
New Drug Application (NDA) Process
Abbreviated New Drug Application (ANDA)-1
Abbreviated New Drug Application (ANDA)-2
Abbreviated New Drug Application (ANDA)-3
Generic Products
Innovator-Generics-Common and Differentiating Points-2
NDA Vs ANDA
Orange book
Orange Book-Therapeutic Equivalence Evaluations Codes_1
Orange Book-Therapeutic Equivalence Evaluations Codes_2
Drug Master File (DMF)-1
Drug Master File (DMF)-2
DMF Review Process
Final Words
Meeting etiquettes_ Part 1
Meeting etiquettes_ Part 2
Certificate Course in Drug Regulatory Affairs (DRA) at UDEMY Faculty details
Certificate Course in Drug Regulatory Affairs (DRA)
at UDEMY
Dr. Sachin Potawale
Director of Pharmasolvers Consultants LLP., Ph.D. awarded in the subject of Pharmaceutical Chemistry, under the Faculty of Pharmaceutical Sciences from Bharati Vidyapeeth Deemed University
Certificate Course in Drug Regulatory Affairs (DRA) at UDEMY Entry Requirements
Certificate Course in Drug Regulatory Affairs (DRA)
at UDEMY
Eligibility criteria
- Prerequisite: Basic level of English & Basic knowledge of Pharmaceutical/Medical field
Conditional Offer
- Not mentioned
Other courses offered by UDEMY
₹599
10 hours
– / –
View Other 2346 Courses
A
Ankur Pandey
Certificate Course in Drug Regulatory Affairs (DRA)
Offered by UDEMY
5
Learning Experience: The course gives you basic knowledge of Drug Regulatory Affairs and their job role
Faculty: It was good
The content was up-to-date, still few topics were missing
Reviewed on 1 Feb 2023Read More
V
Varun H
Certificate Course in Drug Regulatory Affairs (DRA)
Offered by UDEMY
5
Learning Experience: It's amazing and need full information and its so helpfull
Faculty: It's good and they are very kindfull
In course they planed very nice from basic to depth knowledge they given in very good flow
Reviewed on 27 Jan 2023Read More
A
Ajay Anandrao Patil
Certificate Course in Drug Regulatory Affairs (DRA)
Offered by UDEMY
5
Learning Experience: Was knowledgeable thoroughly in deep where I cleared and understand the concept properly
Faculty: Good
Very well structured with assement like MCQs after each session
Course Support: Good
Reviewed on 8 Jan 2023Read More
S
Syed Shujaatullah
Certificate Course in Drug Regulatory Affairs (DRA)
Offered by UDEMY
5
Learning Experience: The online learning experience was amazing on udemy, the course content helps very much to learn about the course.
Faculty: Great
Good
Course Support: Not
Reviewed on 18 Dec 2022Read More
A
Amandeep Singh Rawat
Certificate Course in Drug Regulatory Affairs (DRA)
Offered by UDEMY
4
Learning Experience: Course and content was very insightful and simple. Yoycan learn a lot even if you dont know much about REGULATORY AFFAIRS AND REGULATORY WRITING. The accent was a small barrier in learning.
Faculty: Single faculty was there due to her accent you may face little difficulty. Lectures were good.
Course curriculum include CTD preparation, especially module 2.5 &2.7 parallel writing etc.
Reviewed on 20 Nov 2022Read More
View All 23 Reviews
Certificate Course in Drug Regulatory Affairs (DRA)
at UDEMY
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