Regulatory Affairs

Shree Sai Prakashan is writing a full set of B.Pharm titles to this new NEP 2020 syllabus. Get notified the moment the book for this subject is released, or pre-book sets for your college.

Unit 1 · Fundamentals of Regulatory Affairs 6 hrs

An introduction to drug regulatory affairs; an overview of the principal regulatory agencies including the CDSCO, US FDA, EMA and PMDA; the organizational structure of regulatory bodies; and the role and responsibilities of the regulatory-affairs professional.

Unit 2 · Regulations, Laws and Acts 6 hrs

The regulations, laws and acts governing pharmaceuticals; and the principal regulatory references including the Orange Book, the Purple Book, the Federal Register and the Code of Federal Regulations.

Unit 3 · Regulatory Requirements in Drug Development 6 hrs

The regulatory requirements at each stage of drug development — preclinical studies, the Investigational New Drug application, the phases of clinical trials, and Good Clinical Practice; together with the ICH guidelines that apply.

Unit 4 · Dossier Preparation and the Common Technical Document 6 hrs

The structure and modules of the Common Technical Document (CTD) and electronic CTD; the preparation and compilation of a registration dossier; and the New Drug Application and Abbreviated New Drug Application routes.

Unit 5 · Global Registration and Post-Approval Activities 6 hrs

Registration requirements in the major and emerging markets; post-approval changes, variations and supplements; labelling and packaging requirements; and regulatory inspections and compliance.