JNTUH M.Pharm 2017-2018 (R17) Detailed Syllabus Regulatory aspects herbals and biological practical lab

Regulatory aspects herbals and biological practical lab Detailed Syllabus for Pharmaceutical Regulatory Affairs M.Pharm first year second 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 Regulatory aspects herbals and biological practical lab M.Pharm 2017-2018 (R17) first year second sem is as follows. M.Pharm. I Year II Sem

Preparation of Biologics License Applications (BLA)
Preparation of documents required for Vaccine Product Approval
Comparison of clinical trial application requirements of US, EU and India of Biologics
Preparation of Checklist for Registration of Blood and Blood Products
Registration requirement comparison study in 5 emerging markets (WHO) and preparing check list for market authorization
Registration requirement comparison study in emerging markets (BRICS) and preparing check list for market authorization
Registration requirement comparison study in emerging markets (China and South Korea) and preparing check list for market authorization
Registration requirement comparison study in emerging markets (ASEAN) and preparing check list for market authorization
Registration requirement comparison study in emerging markets (GCC) and preparing check list for market authorization
Preparation of document required for the approval of herbal products of diverse dosage forms(3products) as per regulations requirements

Practical work shall be carried out based on the theory syllabus. For all other M.Pharm 1st Year 2nd Sem syllabus go to JNTUH M.Pharm Pharmaceutical Regulatory Affairs 1st Year 2nd 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.