Diploma in Pharmacovigilance & Data Management

Curriculum

The program combines comprehensive pharmacovigilance training with specialized clinical data management learning and software training in Oracle Argus Safety and Oracle Clinical.

The curriculum progresses from pharmacovigilance and drug safety processes through safety database training before moving into clinical data management processes, systems and clinical data management software.

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 – Pharmaceutical Medicine

• Introduction to Pharmaceutical Medicine
• Pre-clinical Development of Drugs and Biologics
• Clinical Phases of Drug development
• General Pharmacology
• BA-BE Studies
• Pharmacogenetics-Pharmacogenomics
• Toxicology
• Systemic Pharmacology
• Clinical Trial Design
• Intellectual Property Rights
• Personalized Medicine
• Clinical Trials in Pediatrics
• Drug Safety in Pregnancy
• Research Methods for Genetics Studies
• Stem Cell Research and its Applications
• Endpoints in Clinical Trials
• Clinical Trial Registries

Module 4 – 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 5 – 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 6 – 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 7 – Global Pharmacovigilance and Safety Standards

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

Module 8 – 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 9 – 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 10 – 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 11 – Basics of Clinical Data Management

• Introduction to Clinical Data Management
• Application of Computers in Pharmaceutical Research & Development
• Data Management Plan
• Case Report Form Design
• Patient Registration
• Clinical Data Acquisition
• Clinical Data Definition and Database Design
• Training, Education, and Documentation Requirements
• Safety Data Management
• CDM Documentation Overview

Module 12 – Clinical Data Management Processes and Standards

• Data Entry Methods and Processes
• Database Validation and Standards
• Database Closure
• Clinical Data Management Audits
• Measuring Performance in CDM
• Data Validation and Query Management
• Process of Drug Development
• Clinical Data Management Process
• Standard Operating Procedures

Module 13 – Clinical Data Management Systems

• Clinical Data Management Systems
• Database Migration and Archival
• Medical Coding Dictionaries and MedDRA
• Software Tools used in Management of Clinical Trials
• Laboratory Data
• Receipt and Review of Data
• Data Presentation
• Oracle Pharmaceutical Application Suite

Module 14 – Oracle Clinical Fundamentals

• Oracle Clinical Navigation
• Oracle Clinical Overview
• Oracle Clinical – Planning a study
• Oracle Clinical – Designing a study
• Oracle Clinical – Global Library (DVGs, Questions, Question Groups)
• Oracle Clinical – Definition subsystem (DCMs, DCIs, Layouts)
• Oracle Clinical – Validation and Derivation Procedures
• Oracle Clinical – Data Entry
• Oracle Clinical – Discrepancy and DCF Management

Course Completion

• Final Assessment
• Course Certification