Syllabus

Syllabus_Blog

Nirma University

Institute of Pharmacy

 M.Pharm. [Regulatory Affairs & Quality Assurance]

SEMESTER – I

COURSE NAME

PHARMACEUTICAL REGULATORY PRACTICES

Theory Detailed Syllabus

L P T C
3   6 –   6

Drug Regulation

Objectives and Issues, Pharmaceutical Legislation

Regulatory Framework

Mission and Goals of Drug Regulation, Historical Development of Drug Regulation

Indian Regulatory Authorities, Very brief introduction regarding D&C Act, 1940 and rules there under, Guidelines for Import, Export, Manufacturing and distribution of drugs in India.

Regulatory Bodies of Different Countries like USA, UK, Brazil, Australia, Japan, China etc., Other Non-Regulatory Pharmaceutical Functions

Harmonization of Regulatory Guidelines. Guidelines given by ICH, Common Technical Document (CTD), Electronic CTD, Harmonization of Pharmacopoeial standards.

WHO guidelines and its relevance in international registration.

Basics of Clinical trials and Clinical Research, Preclinical studies, Features of Clinical Trials, Good Clinical Practices, Bioavailability studies

Introduction to drug safety and Pharmacovigilance

PRACTICALS

Practical related to the topics covered in theory

Case Studies related to import, export, manufacturing of API and dosage forms in India

Case studies to conduct clinical trials for drugs

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