Has discount
✅
Made in
English
Last updated at
Sat, 06-May-2023
Level
Beginner
Total lessons
11
Total duration
04:25:36 Hours
Number of reviews
1
Total enrolment
40
Avg rating
Short description
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.
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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.
Outcomes
- 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
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