Diploma in Pharmacovigilance & Regulatory Affairs

Curriculum

Course Stats – 26 Modules, 116 Chapters, 113 Quizzes

 

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