Loading ...

Course / Course Details

Drug Regulation as per USFDA [US]

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 3 Hours
  • (0)

Course Requirements

B.Pharm/M.Pharm/PhD/BSc/MSc/
B.Tech/M.Tech/Pharma, Healthcare Working Professionals.

Course Curriculum

  • 2 chapters
  • 35 lectures
  • 1 quizzes
  • 3 Hours total length
Toggle all chapters
1 History of FDA and Related Regulatory Agencies
15 Min

2 FDA Organization
15 Min

3 INVESTIGATIONAL NEW DRUG
15 Min

4 New Drug Application (NDA)
15 Min

5 National Drug Code Directory
15 Min

6 Generic Drug Submissions
15 Min

7 GUIDANCE FOR INDUSTRY
15 Min

8 Over-the-Counter Drug Products
15 Min

9 Patents and Exclusivity
15 Min

10 Prescription Drug Labeling, Advertising and Promotion
15 Min

11 IMPORTANCE OF PACKAGING & LABELLING IN PHARMACEUTICAL INDUSTRY PPT
15 Min

12 Labeling-Lecture by Sunil Bankar video 1
1 Min

13 Labeling-Lecture by Sunil Bankar video 2
1 Min

14 Labeling-Lecture by Sunil Bankar video 3
1 Min

15 Video-Para IV
1 Min

16 FDA inspection video
1 Min

17 FDA Drug Approval Process
1 Min

18 ANDA ppt
15 Min

19 Drug Regulatory Submission- USFDA-Rajashri Ojha' Lecture video 1
1 Min

20 Drug Regulatory Submission- USFDA-Rajashri Ojha' Lecture video 2
1 Min

21 Drug Regulatory Submission- USFDA-Rajashri Ojha' Lecture video 3
1 Min

22 SUPAC Lecture Video 1
1 Min

23 SUPAC Lecture Video 2
1 Min

24 Regulation for OTC PPT
15 Min

25 Guidance/Articles for OTC Regulation 1
15 Min

26 Guidance/Articles for OTC Regulation 1
15 Min

27 Video-Regulation for OTC Lecture by Rajashri Ojha
1 Min

28 Basic of CMC and scientific and Regulatory Writing video 1
1 Min

29 Basic of CMC and scientific and Regulatory Writing video 2
1 Min

30 Basic of CMC and scientific and Regulatory Writing video 2
1 Min

31 Drug Regulation in US-lecture Video 1
1 Min

32 Drug Regulation in US-lecture Video 2
1 Min

33 Drug Regulation in US-lecture Video 3
1 Min

34 Drug Regulation in US-lecture Video 4
1 Min

1 MCQs [Quiz]
10 Min

Instructor

Rajashri Ojha

0 Rating
0 Reviews
39 Students
154 Courses

Course Full Rating

0

Course Rating
(0)
(0)
(0)
(0)
(0)

No Review found

Sign In or Sign Up as student to post a review

Student Feedback

Course you might like

Short Courses
Dossier preparation in CTD/eCTD format
0 (0 Rating)
3,499.00 ₹ 4,200.00 ₹
Regular Courses
Effective CMC Writing & Review Skill For DS & DP
0 (0 Rating)
This course will cover Basics of CMCs, effective technical CMC Writing skills, CTD Module 3-Quality Overall Summary,  Pu...
7,499.00 ₹ 9,000.00 ₹

You must be enrolled to ask a question

Students also bought

  • 0 (0 Rating)
  • 24,999.00 ₹
  • 30,000.00 ₹
Test Webinar 3
Short Courses
  • 0 Lectures
  • N/A
  • 0 (0 Rating)
  • Free
new webinaar
Short Courses
  • 0 Lectures
  • N/A
  • 0 (0 Rating)
  • Free
Clinical Research [CR]
Regular Courses
  • 50 Lectures
  • 10 Min
  • 0 (0 Rating)
  • 9,999.00 ₹
  • 12,000.00 ₹
  • 0 (0 Rating)
  • 24,999.00 ₹
  • 30,000.00 ₹
Medical Device Regulation in India
Short Courses
  • 20 Lectures
  • 3 Hours
  • 0 (0 Rating)
  • 3,499.00 ₹
  • 4,200.00 ₹

3,499.00 ₹

4,200.00 ₹

Add To Cart Buy Now

  • Duration 3 Hours

  • Lectures 35 lessons

  • Category: Pharmaceuticals

  • 1 Quizzes

  • Language: English

  • Skill Level Short Courses

  • Certificate of Completion

  • 7 Days Access

Remove Coupon
Coupon Applied!

More Courses by Author

Discover Additional Learning Opportunities

View All
Short Courses
Biosimilars test and quiz
0 (0 Ratings)
Introduction in BiologicsHistory of BiologicsAdvancing Biomedical ScienceComparison of development a...
7,499.00 ₹ 9,000.00 ₹
Regular Courses
Effective CMC Writing & Review Skill For DS & DP
0 (0 Ratings)
This course will cover Basics of CMCs, effective technical CMC Writing skills, CTD Module 3-Quality...
7,499.00 ₹ 9,000.00 ₹
Short Courses
Drug Regulatory System In Us
0 (0 Ratings)
This course covers History of FDA and Related Regulatory Agencies, FDA & CDER – Organization and res...
3,499.00 ₹ 4,200.00 ₹
Short Courses
Drug regulation in Europe [EU]
0 (0 Ratings)
This course will cover Pharmaceuticals in the European Union, History of Drug Regulation in European...
3,499.00 ₹ 4,200.00 ₹
Short Courses
ICH Q2 [Analytical validations]
0 (0 Ratings)
This module will cover analytical method validation procedure and its importance, ICH Q 2 guidance
1,499.00 ₹ 1,800.00 ₹
Short Courses
ICH Q3 [Impurities]
0 (0 Ratings)
This course will cover ICH Q3 Impurities guidance, element classification, risk assessment and contr...
1,499.00 ₹ 1,800.00 ₹

Shopping Cart

Loading...