Diploma in Pharmacovigilance & Regulatory Affairs

Curriculum

The program combines comprehensive pharmacovigilance training with specialized learning in pharmaceutical regulatory affairs and structured software training in Oracle Argus Safety.

The curriculum progresses from pharmacovigilance and drug safety processes through Oracle Argus Safety training before moving into pharmaceutical regulations, regulatory submissions, product-development requirements and regulatory strategy.

Oracle Argus Safety training provides practical exposure to drug safety software as part of the Pharmacovigilance component of the program.

 

Module 1 – General Introduction

• Pharmaceutical & CR – Industry Overview
• Introduction to Clinical Research
• Stakeholders and Roles in Clinical Research
• History and Milestones in Clinical Research
• Principles of Good Clinical Practice
• Technologies in Clinical Trial Management
• Overview of Clinical Research Regulatory Bodies

Module 2 – Epedemiology and Evidence Based Medicine (EBM)

• Epidemiology 1 – Introduction
• Epidemiology 2 – Concept of Causation
• Epidemiology 3 – Epedemiological Study Designs
• Epidemiology 4 – Statistics
• Evidence Based Medicine

Module 3 – Principles of Pharmacovigilance

• General Overview of Pharmacovigilance
• History and aim of Pharmacovigilance
• Drug dependence
• Vaccine Vigilance
• Principles of Signal Detection in Pharmacovigilance
• Communication in Pharmacovigilance
• Post-Marketing Surveillance

Module 4 – Pharmacovigilance and Selected System Organ Classes

• Dermatological ADRs
• Gastrointestinal ADRs
• Haematological ADRs
• Renal ADRs
• Ocular Side Effects of Prescription Medications
• Drug Safety in Pregnancy
• Hepatic Drug Reactions
• Anaesthetic Adverse Drug Reactions
• Pharmacovigilance in Pediatrics
• The Cardiovascular Spectrum of Adverse Drug Reactions
• Drugs and the Elderly

Module 5 – Pharmacovigilance Systems

• Audits and Inspections in Pharmacovigilance
• Pharmacovigilance Department
• Qualified Person for Pharmacovigilance
• Standard Operating Procedures in Pharmacovigilance
• Literature Review
• MedDRA
• Eudravigilance
• Assessment of Compliance
• Mergers and Acquisitions
• Softwares used in Pharmacovigilance

Module 6 – Global Pharmacovigilance and Safety Standards

• WHO & Safety Reporting
• CIOMS Groups & Functions
• Good Pharmacovigilance Practice

Module 7 – Pharmacovigilance Regulations and Guidelines

• Safety Reporting
• Individual case safety reports
• Periodic safety update reports
• Indian Regulations with specific reference to Schedule Y
• Regulatory Pharmacovigilance in EU

Module 8 – Pharmacoepedemiology

• Introduction to Pharmacoepidemiology
• Molecular Genetic Pharmacoepidemiology
• Analysis of Pharmacoepidemiological Data
• Studies of Drug Use
• Case Control Studies
• Cohort Studies
• Data Sources
• Measures of Frequency & Risk
• Advanced Issues in Pharmacoepidemiology
• Errors in Pharmacoepidemiology

Module 9 – Oracle Argus Safety Essentials

• Overview and Navigation
• Overview of Argus Menus
• Case Form Features
• Drug and Event Coding
• Case Entry and Processing
• Advanced Conditions
• Reporting and Submissions

Module 10 – Introduction to the Judicial System in India

• Introduction to Medical Ethics, Medical Malpractice
• Overview of Judicial System in India
• Legitimacy and Paternity
• Privileged Communication and Professional Secrets

Module 11 – Drugs and Cosmetic Act and Rules

• Introduction, Aims and Objectives, Definitions
• Schedules to Drug Rules
• Import, Manufacture and Sale of Drugs
• Labeling and Packaging of Drugs

Module 12 – Schedule Y

• Introduction, Amendments to Schedule Y
• Clinical Trials
• Studies in Special Population, Post Marketing Surveillance and Special Studies
• Appendices

Module 13 – Indian Regulations Governing Clinical Trials

• Regulatory Authorities in India
• Guidelines and important provisions
• Indian Regulatory Approval Process and approval timelines

Module 14 – Regulatory Regime in US

• Responsibilities of US FDA
• FDA Centers
• Code of Federal Regulations
• FDA guidelines for industry

Module 15 – European Medicines Agency (EMEA)

• Introduction, Roles and Responsibilities of EMEA
• Committees of EMEA
• EU Clinical Directives
• EUDRA CT

Module 16 – Regulations in Japan

• Organization and Function of MHLW (JAPAN)
• Pharmaceutical Laws and Regulations in Japan
• Drug Development in Japan

Module 17 – In-Vitro and In-Vivo Pre-clinical studies

• ICH Safety Guidelines related to Carcinogenicity, Genotoxicity, Reprotoxicity
• ICH safety guidelines related to pharmacology and immunotoxicology studies

Module 18 – Efficacy Topics related to Clinical Studies

• Clinical Safety
• Dose Response Studies
• Clinical Evaluation

Module 19 – Common Technical Document (CTD)

• General principles of CTD
• Modules with Diagrammatic representation
• eCTD

Module 20 – IND and NDA Requirements

• IND and NDA applications in U.S
• IND and NDA Applications in India

Module 21 – CMC Information

• CMC for Phase I
• CMC for Phase II and III

Module 22 – Overview of GHTF

• Organization
• Study Groups and Documents

Module 23 – Regulatory Processes for Medical Devices and Veterinary Products

• U.S Scenario
• Indian Scenario

Module 24 – Biosimilars EMEA Guidance and Regulations

• Guidelines and Applications of Biosimilars
• Specific Guidelines

Module 25 – Biopharmaceutical Indian Regulations and Guidelines

• Regulatory Bodies
• Guidelines for Pre-Clinical and Clinical studies

Module 26 – Regulatory Strategic Planning, Interfacing and Corporate Communications

• Regulatory Strategic Planning
• Corporate Communications

Course Completion

• Final Assessment
• Course Certification