Pharmaceutical Regulatory Science Book B.Pharm 8th Semester

                                                                     Syllabus

                     Pharmaceutical Regulatory Science

(Course Code: BP804ET)

Module 01                                                                                        10 Hours

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.

Module 02                                                                                        10 Hours

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).

Module 03                                                                                        10 Hours

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, Document (eCTD), ASEAN Common Technical Document (ACTD) research.

Module 04                                                                                        08 Hours

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.

Module 05                                                                                        07 Hours

Regulatory Concepts

·         Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple books.