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  • Writer's pictureLast Bench Pharmacist

B Pharm Pharmaceutical Regulatory Sciences PDF Notes


B-Pharmers, prepare to navigate the intricate world of drug regulations in B Pharm Pharmaceutical Regulatory Sciences PDF Notes! Buckle up as we explore the science behind the rules, ensuring medications are safe, effective, and meet quality standards. Imagine understanding the rigorous journey drugs take from discovery to market approval, complying with regulatory agencies like CDSCO and USFDA. We'll delve into Good Manufacturing Practices (GMPs), ensuring quality at every step, and explore the intricate process of drug registration and approvals. Feeling curious about clinical trials? We'll unveil the ethical considerations and regulations that safeguard participant safety and data integrity. Remember, regulatory science is crucial for public health; by the end of this Course, you'll be equipped to contribute to the development of safe and effective medications that make a difference!


B Pharm Pharma Marketing Management Notes
B Pharm Pharma Marketing Management Notes

Scope


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:-


  1. Know about the process of drug discovery and development

  2. Know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals

  3. Know the regulatory approval process and their registration in Indian and international markets


B Pharm Pharmaceutical Regulatory Sciences PDF Notes


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 163 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


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