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Pharmaceutical Regulatory Science Book B.Pharm 8th Semester

Click below to Buy E-Book Edition:
Buy Thakur Publication’s Pharmaceutical Regulatory Science book for B.Pharm 8th Sem as per Latest Syllabus of PCI. Pharmaceutical Regulatory Science book covered all topics.
The Pharmaceutical Regulatory Science book for B.Pharm 8th Semester is an essential guide to the regulatory requirements of the pharmaceutical industry.
EXPRESS SHIPPING · REVISED EDITION · EXAM-ORIENTED
It covers topics such as drug approval, clinical trials, pharmacovigilance, quality assurance, and intellectual property rights. The book provides practical knowledge and skills for navigating the complex regulatory landscape of the pharmaceutical industry.
AUTHOR- Dr. Vitthal Vishram Chopade, Dr. Rajinder Mann
ISBN- 978-93-90972-02-9
Tax excluded
Click below to Buy E-Book Edition:
Buy Thakur Publication’s Pharmaceutical Regulatory Science book for B.Pharm 8th Sem as per Latest Syllabus of PCI. Pharmaceutical Regulatory Science book covered all topics.
The Pharmaceutical Regulatory Science book for B.Pharm 8th Semester is an essential guide to the regulatory requirements of the pharmaceutical industry.
EXPRESS SHIPPING · REVISED EDITION · EXAM-ORIENTED
It covers topics such as drug approval, clinical trials, pharmacovigilance, quality assurance, and intellectual property rights. The book provides practical knowledge and skills for navigating the complex regulatory landscape of the pharmaceutical industry.
AUTHOR- Dr. Vitthal Vishram Chopade, Dr. Rajinder Mann
ISBN- 978-93-90972-02-9
Syllabus
Pharmaceutical Regulatory Science
(Course Code: BP804ET)
Module 01 10 Hours
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.
Module 02 10 Hours
Regulatory Approval Process
· Approval processes and timelines involved in Investigational New Drug (IND).
· New Drug Application (NDA).
· Abbreviated New Drug Application (ANDA).
· Changes to an approved NDA /ANDA.
Regulatory Authorities and Agencies
· Overview of regulatory authorities of India, United States, European Union,
Australia, Japan, Canada (Organization structure and types of applications).
Module 03 10 Hours
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.
Module 04 08 Hours
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.
Module 05 07 Hours
Regulatory Concepts
· Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple books.