Course drug regulatory affairs offer various tutorials in the form of power point presentation and videos. Various tutorials starts with the understanding of various issues from the scratch i.e. Drug discovery, preclinical development, clinical development (with explanation of schedules under Drug and Cosmetic Act, INDA and NDA followed by rules and regulations industry should follow (if the drug is approved for its manufacture).
Then as we move ahead, we learn more about regulatory aspects of bulk drug/formulation manufacture, formation of standard operating procedures, quality assurance and validation, drug master files, common technical document, Traditional and E-submission.
Last but not the least, the learners would also be taught about the Patents and Copyright and would be introduced to the various international regulatory agencies i.e. USFDA, MHRA etc.
Who should take this course?
Pharma students precisely those studying for post graduate diploma in drug regulatory affairs.Secondly, those who intend to begin their career in drug regulatory affairs, Pharma KPO’S, clinical research etc. moreover, it can also be beneficial for research scholars intending to pursue research in formulation development.
What is unique about the course?
Complete and exhaustive view of the pharma related procedures which can be an eye opener to strategize oneself or the team of the pharma company in the pathway of the drug development and its regulatory issues.
Why should one enroll?
Pharma graduates must enroll in the program to have a clear view and understanding of various rules and regulations which they have to follow while working for particular post related to DRA, Clinical research, QA, QC, formulation development and management of any pharmaceutical industry.
Is there any certificate for this course?
Course completion certificate would be given at the end on the successful completion of the training on behalf of Erica institute an educational division of Chahat Pharma Pvt. Ltd.
What are the course outcomes?
Where the pharma graduation and post graduation courses gives the complete insight of the pharmaceutical or the drug molecule, this course is an icing on the cake which trains the individual or KPO on regulatory issues which may also help them in becoming good mangers in the prospective pharmaceutical company/ KPO.
Does this course prepare for any certification?
Yes, this is definitely helpful for students already pursuing post graduate diploma in drug regulatory affairs
What does the course offer?
Details of the topics and subtopics for the complete course:
1. Drug discovery and development
2. Preclinical/ Non-clinical studies
3. CDSCO Schedule Y
4.Clinical development of a new drug
5. Standard Operating Procedure
6. NDA, IND, ANDA
7.Quality assurance and validation
9. Regulatory aspects
10.Common technical document
11. Drug Master Files
12. National and International Regulatory authorities
- 03 Videos
- 01 PPT
- 02 Documents
- 01 Online Test
- 01 Assignment
NOTE:Get approximately 30+ videos, 10+ PPT's, 3 documents, 3 online tests and 3 assignments in the complete course. Check out other modules of the course here: Drug regulatory affairs module 02
Language of instruction: English