4.38 (32 Ratings)
Regulatory Affairs in Pharmaceutical Industry
₹199
₹499
-
LevelIntermediate
-
Total Enrolled99
-
Duration24 minutes
-
Enrollment validityEnrollment validity: 30 days
-
CertificateCertificate of completion
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Description
In an industry governed by strict global standards, Regulatory Affairs serves as the bridge between pharmaceutical innovation and market access. This comprehensive course provides a solid foundation in regulatory frameworks, compliance strategies, and dossier preparation for professionals navigating the complexities of drug development and commercialization.
Participants will gain practical insights into global regulatory guidelines (like CDSCO, USFDA, EMA, MHRA), submission pathways, and the evolving role of regulatory affairs in the product lifecycle management—from clinical trials to post-marketing surveillance.
Course Curriculum
Regulatory Affairs in Pharmaceutical Industry
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Part 1 – Introduction
00:31 -
Part 2 – Understanding R.A
01:08 -
Quiz
-
Part 3 – Importance of R.A
00:44 -
Quiz
-
Part 4 -Regulatory Agencies
01:26 -
Quiz
-
Part 5-Public Health as the Paramount Concern
01:17 -
Quiz
-
Part 6 – Ensuring Safety and Efficacy of Drugs and Medical Devices
01:05 -
Quiz
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Part 7- Regulatory Affairs Emphasis
01:54 -
Quiz
-
Part 8 – New Drug Approval
03:43 -
Quiz
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Part 9 – Abbreviated New Drug Application (ANDA)
00:46 -
Quiz
-
Part 10 – Key Components of ANDA
01:30 -
Quiz
-
Part 11 – Steps of ANDA
03:36 -
Quiz
-
Part 12 – Standardizing Regulations Globally
01:01 -
Quiz
-
Part 13 – Challenges in Regulating Innovative Therapies
00:57 -
Quiz
-
Part 14 – Career Opportunities in R.A
00:49 -
Quiz
-
Part 15 – Educational Qualifications
00:40 -
Quiz
-
Part 16 – Essential Skills to Excel in R.A
01:44 -
Quiz
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Part 17 – Role of R.A
01:47 -
Quiz
-
Part 18 – Color Coded Regulatory References
02:24 -
Quiz
-
Part 19 – Key Takeaways
01:34
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Course Ratings & Reviews
4.4
Total 32 Ratings
5
21 Ratings
4
5 Ratings
3
4 Ratings
2
1 Rating
1
1 Rating
nice cource
Its is very basics its seeming if you add some more depth information about the Regulatory Agenies and career bridge in global level it is good
Very good and informative session was it. provides basic knowledge about regulatory
Good
.
good
GOOD
nice
Course was good for a Basic Understanding of regulatory affairs, but most of the regulatory things should cover within course.
good course
It's very effective and good
Very informative
Informative
The course is well-structured and informative, covering essential regulatory affairs concepts. It provides valuable insights into pharmaceutical regulations, making it a great starting point for aspiring professionals.
its a basic subject just watching some youtube video is enough.no need to do with 200 rupees and the captions was not perfect i mean like spellings are wrong
nice explanation.
Excellent learning experience
Nice
It was a beneficial course and an excellent presentation.
Nice information
Good course but content to be improve
Good experience
It's amazing course
Good series
Clearly explained.
Very Informative Course
good
learned a lot about RA
Good course
not a lot of detail at all
₹199
₹499
-
LevelIntermediate
-
Total Enrolled99
-
Duration24 minutes
-
Enrollment validityEnrollment validity: 30 days
-
CertificateCertificate of completion
Target Audience
- Pharma professionals from manufacturing.
- QA, QC, and Regulatory Affairs.
- Students pursuing D.Pharm, B.Pharm, M.Pharm, Ph.D, & Pharm D.
Educators
Course Ratings & Reviews
4.4
Total 32 Ratings
5
21 Ratings
4
5 Ratings
3
4 Ratings
2
1 Rating
1
1 Rating
nice cource
Its is very basics its seeming if you add some more depth information about the Regulatory Agenies and career bridge in global level it is good
Very good and informative session was it. provides basic knowledge about regulatory
Good
.
good
GOOD
nice
Course was good for a Basic Understanding of regulatory affairs, but most of the regulatory things should cover within course.
good course
It's very effective and good
Very informative
Informative
The course is well-structured and informative, covering essential regulatory affairs concepts. It provides valuable insights into pharmaceutical regulations, making it a great starting point for aspiring professionals.
its a basic subject just watching some youtube video is enough.no need to do with 200 rupees and the captions was not perfect i mean like spellings are wrong
nice explanation.
Excellent learning experience
Nice
It was a beneficial course and an excellent presentation.
Nice information
Good course but content to be improve
Good experience
It's amazing course
Good series
Clearly explained.
Very Informative Course
good
learned a lot about RA
Good course
not a lot of detail at all