USFDA, ESG, eCTD, PSUR, Electronic communication, Data submission tool, Regulatory affairs,
Sub Category
- Engineering
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Objectives
- USFDA-Electronic submission gateway
- Submission of electronic information to USFDA
- Submission of eCTD through online submission tool
- Preparation activities for submission
- Application for account generation
- Regulatory affairs
- Guidance for Approval of Pharmaceutical Product
- Generic pharmaceutical product registration
- Electronic communication between USFDA and Applicant
- Procedure for submission of electronic data to FDA
Pre Requisites
- Pharmacy Profession
- Regulatory affairs associate
- Pharmaceutical industry Background
- Curiosity towards learning
- Science education
FAQ
- Q. How long do I have access to the course materials?
- A. You can view and review the lecture materials indefinitely, like an on-demand channel.
- Q. Can I take my courses with me wherever I go?
- A. Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don't have an internet connection, some instructors also let their students download course lectures. That's up to the instructor though, so make sure you get on their good side!
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Coupon Code(s)