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Course / Course Details

Drug Regulation as per USFDA [US]

  • Rajashri Ojha image

    By - Rajashri Ojha

  • (0)

Course Requirements

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

10-10-5

Installment Timeline

Upfront
1,399.60 ₹ (40%)
40
1,399.60 ₹ (40%)
20
699.80 ₹ (20%)

Capacity

10 % Capacity Fillup
Pay in Installments

Course Curriculum

  • 2 chapters
  • 1 quizzes
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1 LMS SOP for students
15 Min

2 History of FDA and Related Regulatory Agencies
15 Min

3 FDA Organization
15 Min

4 INVESTIGATIONAL NEW DRUG
15 Min

5 New Drug Application (NDA)
15 Min

6 National Drug Code Directory
15 Min

7 Generic Drug Submissions
15 Min

8 GUIDANCE FOR INDUSTRY
15 Min

9 Over-the-Counter Drug Products
15 Min

10 Patents and Exclusivity
15 Min

11 Prescription Drug Labeling, Advertising and Promotion
15 Min

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

13 Labeling-Lecture by Sunil Bankar video 1
1 Min

14 Labeling-Lecture by Sunil Bankar video 2
1 Min

15 Labeling-Lecture by Sunil Bankar video 3
1 Min

16 Video-Para IV
1 Min

17 FDA inspection video
1 Min

18 FDA Drug Approval Process
1 Min

19 ANDA ppt
15 Min

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

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

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

23 SUPAC Lecture Video 1
1 Min

24 SUPAC Lecture Video 2
1 Min

25 Regulation for OTC PPT
15 Min

26 Guidance/Articles for OTC Regulation 1
15 Min

27 Guidance/Articles for OTC Regulation 1
15 Min

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

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

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

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

32 Drug Regulation in US-lecture Video 1
1 Min

33 Drug Regulation in US-lecture Video 2
1 Min

34 Drug Regulation in US-lecture Video 3
1 Min

35 Drug Regulation in US-lecture Video 4
1 Min

1 MCQs [Quiz]
10 Min

Instructor

Rajashri Ojha

4 Rating
1 Reviews
52 Students
155 Courses

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  • Category: Pharmaceuticals

  • 1 Quizzes

  • Language: English

  • Skill Level Short Courses

  • Certificate of Completion

  • 7 Days Access

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