Pharmaceutical Regulatory Science -Theory detailed Syllabus Scheme for Bachelor of Pharmacy (B.Pharm), 2019 regulation has been taken from the University of Mumbai official website and presented for the Pharmacy students. For Course Code, Subject Name, Continuous Mode, SE Marks, SE Duration, Total, Marks, Duration in Hours, Total Marks, and other information, do visit full semester subjects post given below.
For all other Mumbai University B.Pharm 8th Sem Syllabus 2019 Pattern, do visit B.Pharm 8th Sem 2019 Pattern Scheme. The detailed syllabus scheme for pharmaceutical regulatory science -theory is as follows.
BP804ET: Pharmaceutical Regulatory Science -Theory Syllabus for B.Pharm 8th Sem 2019 Pattern Mumbai University
Scope:
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Objectives
Upon completion of the subject student shall be able to;
- Know about the process of drug discovery and development
- Know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals
- Know the regulatory approval process and their registration in Indian and international markets
UNIT I 10
New Drug Discovery and development Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development.
UNIT -II 10
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UNIT -III 10
Registration of Indian drug product in overseas market Procedure for export of pharmaceutical products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD), electronic Common Technical Document (eCTD), ASEAN Common Technical Document (ACTD)research
UNIT -IV 8
Clinical trials Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee – formation and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance – safety monitoring in clinical trials
UNIT -V 7
For the complete Syllabus, results, class timetable, and many other features kindly download the iStudy App
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Recommended books (Latest edition):
- Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
- The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health care Publishers.
- New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.
- Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.
- FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited by Douglas J. Pisano, David Mantus.
- Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143
- Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A. Rozovsky and Rodney K. Adams
- Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick P. Ognibene
- Drugs: From Discovery to Approval, Second Edition By Rick Ng
For detail syllabus of all other subjects of Bachelor of Pharmacy (B.Pharm), 2019 regulation do visit B.Pharm 8th Sem Subjects syllabus for 2019 regulation.