Institute of Pharmacy
M.Pharm. [Regulatory Affairs & Quality Assurance]
SEMESTER – I
PHARMACEUTICAL REGULATORY PRACTICES
Theory Detailed Syllabus
L P T C
3 6 – 6
Objectives and Issues, Pharmaceutical Legislation
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
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