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Course overview
This course covers the fundamental aspects
and practical knowledge about Regulatory Affairs (RA) in detail including the academic
& industry prevalence and existence, Scope and career opportunities and the
importance of RA in pharmaceutical industry. The present modules deal with Global
Submissions and Product Life Cycle Management.
The content and methodology of our
courses are structured to complement self-directed learning. As such,
participants will be able to review course material at their own pace, however,
should complete the course within the allocated time provided for the course.
What will i learn?
- What is Regulatory Affairs
- The role of Regulatory Affairs department
- What is DMF and types of DMF
- Preparation and submission of DMF
- Organization of the common technical document for the registration of pharmaceuticals for human use
- Major Regulatory Authorities
- Registration of Drug and Dossier Preparation (CTD and eCTD submissions)
- Regulatory requirements of EU, MHRA, TGA and ROW countries
- Global submission of IND, NDA, ANDA
- Regulatory Affairs in Clinical trials
- Product Life Cycle - Regulatory Affairs Perspective
Requirements
- This course is open to all individuals, especially the graduating individuals/Freshers in Pharmacy/Science domain and Trainees seeking to obtain a general overview of the fundamentals of Regulatory Affairs and to understand the scope & opportunities exist in the industry and academics.
Curriculum for this course
11 Lessons
04:25:36 Hours
Pharmaceutical Industry: Scope and Opportunities
1 Lessons
00:36:53 Hours
-
General Module - Pharmaceutical Industry – Opportunities
Preview 00:36:53
What is Regulatory Affairs
1 Lessons
00:19:20 Hours
-
What is Regulatory Affairs
00:19:20
The role of Regulatory Affairs department
1 Lessons
00:15:54 Hours
-
The role of Regulatory Affairs department
00:15:54
Development of Generic Drug Products
1 Lessons
00:22:42 Hours
-
Development of Generic Drug Products
00:22:42
Drug Master File
1 Lessons
00:16:52 Hours
-
Drug Master File
00:16:52
Organization of the common technical document for the registration of pharmaceuticals for human use
1 Lessons
00:18:33 Hours
-
Organization of the common technical document for the registration of pharmaceuticals for human use
00:18:33
Major Regulatory Authorities
1 Lessons
00:25:50 Hours
-
Major Regulatory Authorities
00:25:50
Registration of Drug and Dossier Preparation (CTD and eCTD submissions)
1 Lessons
00:27:13 Hours
-
Registration of Drug and Dossier Preparation - CTD and eCTD submissions
00:27:13
Regulatory requirements of USFDA, EMA, MHRA, TGA and ROW countries
1 Lessons
00:41:20 Hours
-
Regulatory requirements of USFDA, EMA, MHRA, TGA and ROW countries
00:41:20
Post-approval changes and Product Life Cycle - Regulatory Affairs Perspective
1 Lessons
00:20:59 Hours
-
Post-approval changes and Product Life Cycle
00:20:59
Quiz
1 Lessons
00:20:00 Hours
-
Quiz - Multiple Choice Question
0:20:00
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Other related courses
05:54:47 Hours
Updated Sun, 11-Aug-2024
19
₹ 4999
₹ 999
About instructor
Nishita Gaiki
Ms. Nishita Gaiki has
over 16 years of rich experience in Pharmaceutical industry with key focus on
Pharmaceutical Research & Development and Regulatory Affairs. She holds Bachel...
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