Free Download Pharmaceutical Regulatory Science Notes in pdf – Bpharm 8th Semester. High quality, well-structured and Standard Notes.
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In this post you can download notes of Pharmaceutical Regulatory Science (BP804ET). All units are available to download for free.
Pharmaceutical Regulatory Science Notes Unit 1 – 5
UNIT – 1
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 – 2
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)
UNIT – 3
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 – 4
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 – 5
Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book,
Federal Register, Code of Federal Regulatory, Purple book
Bpharm 8th Semester
Biostatistics & Research Methodology
Pharmaceutical Regulatory Science
Quality Control & Standardization of Herbals
Pharmacological Screening Methods
Advanced Instrumentation Techniques
Dietary Supplements & Neutraceuticals
Pharmaceutical Product Development
Scope of Pharmaceutical Regulatory Science
This course is designed to impart the fundamental knowledge on the regulatory
requirements for approval of new drugs, and drug products in regulated markets of
India & other countries like US, EU, Japan, Australia,UK etc. It prepares the students
to learn in detail on the regulatory requirements, documentation requirements, and
registration procedures for marketing the drug products.
Objectives of Pharmaceutical Regulatory Science
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