Syllabus

GRA Syllabus _Blog

Nirma University

Institute of Pharmacy

M.Pharm. [Regulatory Affairs & Quality Assurance]

SEMESTER – II

COURSE NAME: GLOBAL REGULATORY AFFAIRS

THEORY (DETAILED SYLLABUS)  

L   P   T   C

                                                                                                          3   3   –   5

Regulatory Requirements as per US-FDA guidelines

Drug Approval Process like IND, NDA, ANDA

Regulation of Non-Prescription Healthcare Products (OTC drugs), Orphan drug Indications, and Orange Book

Regulation of Dietary Supplements, Botanicals and Nutraceuticals

Post Approval Changes (PAC) including SUPAC, BACPAC

Post market surveillance

Regulatory requirements in European Union (EU) including EU community code on medical products, EEPIA and ABPI codes.

Regulatory guidelines of Brazil (ANVISA) and Australia (TGA)

Public policy, Regulatory, Ethical and Legal issues related to vaccines

Regulations related to biotechnology derived products and biosimilars

Regulation of Medical Devices including device classification, investigational device exemption (IDE) applications and humanitarian device exemptions

Human Genetic Research and Bioethics

 

PRACTICALS

No of Practical/ assignments based on afore mentioned theory.

Case studies related to prepare dossiers of drug or formulations as per the requirement of different countries

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