4.38 (32 Ratings)

Regulatory Affairs in Pharmaceutical Industry

199 499

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

  • 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
  • Part 7- Regulatory Affairs Emphasis
    01:54
  • Quiz
  • Part 8 – New Drug Approval
    03:43
  • Quiz
  • 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
  • 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
SM
2 months ago
nice cource
IP
4 months ago
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
DK
4 months ago
Very good and informative session was it. provides basic knowledge about regulatory
VS
4 months ago
Good
KK
5 months ago
.
good
DS
5 months ago
GOOD
AK
5 months ago
nice
BN
6 months ago
Course was good for a Basic Understanding of regulatory affairs, but most of the regulatory things should cover within course.
NA
6 months ago
good course
SB
7 months ago
It's very effective and good
DM
8 months ago
Very informative
VM
8 months ago
Informative
PA
10 months ago
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
KC
11 months ago
nice explanation.
AD
1 year ago
Excellent learning experience
VK
1 year ago
Nice
SK
1 year ago
It was a beneficial course and an excellent presentation.
Nice information
YS
1 year ago
Good course but content to be improve
AG
1 year ago
Good experience
S
1 year ago
It's amazing course
PC
2 years ago
Good series
NS
2 years ago
Clearly explained.
PC
2 years ago
Very Informative Course
AS
2 years ago
good
KS
2 years ago
learned a lot about RA
SC
2 years ago
Good course
RF
2 years ago
not a lot of detail at all
199 499

Target Audience

  • Pharma professionals from manufacturing.
  • QA, QC, and Regulatory Affairs.
  • Students pursuing D.Pharm, B.Pharm, M.Pharm, Ph.D, & Pharm D.

Course Ratings & Reviews

4.4
Total 32 Ratings
5
21 Ratings
4
5 Ratings
3
4 Ratings
2
1 Rating
1
1 Rating
SM
2 months ago
nice cource
IP
4 months ago
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
DK
4 months ago
Very good and informative session was it. provides basic knowledge about regulatory
VS
4 months ago
Good
KK
5 months ago
.
good
DS
5 months ago
GOOD
AK
5 months ago
nice
BN
6 months ago
Course was good for a Basic Understanding of regulatory affairs, but most of the regulatory things should cover within course.
NA
6 months ago
good course
SB
7 months ago
It's very effective and good
DM
8 months ago
Very informative
VM
8 months ago
Informative
PA
10 months ago
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
KC
11 months ago
nice explanation.
AD
1 year ago
Excellent learning experience
VK
1 year ago
Nice
SK
1 year ago
It was a beneficial course and an excellent presentation.
Nice information
YS
1 year ago
Good course but content to be improve
AG
1 year ago
Good experience
S
1 year ago
It's amazing course
PC
2 years ago
Good series
NS
2 years ago
Clearly explained.
PC
2 years ago
Very Informative Course
AS
2 years ago
good
KS
2 years ago
learned a lot about RA
SC
2 years ago
Good course
RF
2 years ago
not a lot of detail at all

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