Diploma in Pharmacovigilance & Data Management

Curriculum

Course Stats – 14 Modules, 125 Chapters, 121 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 – 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
• Business Process Workflow
• Case Entry and Processing
• Case Form Features
• Coding Terms and MedDRA browser
• Advanced Conditions
• Dashboards and Utilities
• 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