JNTUH M.Pharm 2017-2018 (R17) Detailed Syllabus Drug regulations and registration lab

Drug regulations and registration lab Detailed Syllabus for Pharmaceutical Regulatory Affairs M.Pharm first year first sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course. The detailed syllabus for Drug regulations and registration lab M.Pharm 2017-2018 (R17) first year first sem is as follows. M.Pharm. I Year I Sem

Case studies on Change Management/ Change control. Deviations and Corrective & Preventive Actions (CAPA)
Import of drugs for research and developmental activities
GMP Audit Requirements as per CDSCO
Preparation of checklist for registration of IND as per ICH CTD format.
Preparation of checklist for registration of NDA as per ICH CTD format.
Preparation of checklist for registration of ANDA as per ICH CTD format.
Comparative study of DMF system in US, EU and Japan
Preparation of regulatory submission using eCTD software
Documentation of raw materials analysis as per official monographs
Preparation of audit checklist for various agencies
Preparation of submission to FDA using eCTD software
Preparation of submission to EMA using eCTD software
Preparation of submission to MHRA using eCTD software

For all other M.Pharm 1st Year 1st Sem syllabus go to JNTUH M.Pharm Pharmaceutical Regulatory Affairs 1st Year 1st Sem Course Structure for (R17) Batch. All details and yearly new syllabus will be updated here time to time. Subscribe, like us on facebook and follow us on google plus for all updates. Do share with friends and in case of questions please feel free drop a comment.