Courses 4: CR + Regulatory Affairs (RA)
At Clinsquare, we are more than just an institute; we are your partners in a journey towards a thriving career in clinical research.
Course Description
What You Will Get
- Basic understanding and terminologies related to Drug Regulatory Affairs (DRA)
- Understand the role and responsibilities of a Regulatory Affairs Professional in the Pharmaceutical industry
- Regulatory agencies and their responsibilities
- Drug approval process in USA: ANDA, sNDA, and NDA and by other agencies
- Biologicals approval pathways
- Drug Master File (DMF)
- Common Technical Document (CTD)
- Important questions for written tests and interviews
- All the contents from course 1
- Certification of completion
- Course material
Course Description
- Basic understanding and terminologies related to Drug Regulatory Affairs (DRA)
- Understand the role and responsibilities of a Regulatory Affairs Professional in the Pharmaceutical industry
- Regulatory agencies and their responsibilities
- Drug approval process in USA: ANDA, sNDA, and NDA and by other agencies
- Biologicals approval pathways
- Drug Master File (DMF)
- Common Technical Document (CTD)
- Important questions for written tests and interviews
- All the contents from course 1
What You Will Get
Certificate of completion
- Course material