Diploma in Pharmacovigilance & Medical Writing

Curriculum

The program combines comprehensive pharmacovigilance training with specialized learning in scientific, clinical and regulatory medical writing.

The curriculum progresses from pharmacovigilance and drug safety processes through Oracle Argus Safety training before moving into medical writing, regulatory documentation, publication writing and scientific communications.

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 – Basics of Good Medical Writing

• Introduction & Scope of Medical Writing
• Good Versus Poor Scientific Writing – An Orientation
• Statistics in Medical Writing

Module 11 – Computer Skills

• MS Word, Excel & Other Open Source Software
• Effective Internet Literature Search

Module 12 – Overview of the Regulatory, Marketing and Drug Promotion Process

• Introduction to Regulatory Medical Writing
• Investigation New Drug & Investigational Device Exemption Application
• Protocols, Amendments & Study Reports
• Investigator Brochure & Product Labels
• NDA’s, BLA’s & PMA’s
• Annual Reports
• Product Labeling
• Abstracts & Posters for Scientific Meetings
• Manuscripts for Publication in Scientific Journals
• Legal-Copyright-IP Issues in Medical writing

Module 13 – Common Technical Document

• Introduction and overview of CTD and eCTD
• Putting it all together – CTD Module 1
• Putting it all together – Producing the CTD Modules
• Multi-region submissions & submission standards
• Interfacing with regulatory agencies and answering queries
• Aggregate safety reports

Module 14 – Protocol, Investigator’s Brochure and Case Report Forms

• Writing clinical study protocols
• Introduction to writing Investigator Brochure’s
• Writing case report forms
• Writing regulatory compliant informed consent forms
• ICSR – Patient Narratives

Module 15 – Clinical Study Report

• Parts of a Clinical Study Report
• Templates & Boilerplate Text
• Tips on writing each section of the CSR

Module 16 – Sentence Control

• Fundamentals of Sentence Construction
• Controlling Voice of Sentence for Readability
• Correct Punctuation
• Consistency in Tense Use
• Imprecise Words and Phrases
• Word Order and Pronouns
• Subject – Verb Agreement

Module 17 – Writing Flow and Cohesiveness

• Writing Effective Paragraphs
• Using Effective Data Displays
• Using Style Guides for Consistent Medical Writing
• Overcoming Writers Block

Module 18 – Publication Writing

• Structure of a Scientific Paper
• Electronic Submissions
• Abstract for Scientific Meeting
• Case Report
• Review
• Ethics of Publication
• Guidelines of Publication (e.g. CONSORT, ICMJE, GPP)
• Referencing Guidelines & Taking Software’s Help

Module 19 – Documents in Medico-Marketing

• Leave behind literature (LBL), Visual Aids and Brochure’s
• Continuing Medical Education (CME) for Doctors
• Evidence Based Medicine
• MR Training Manual
• Web Content, Audio-Visual Aids, CDs

Module 20 – Managing the Review Process

• Effective Review Practices
• Managing Incongruous Comments from Reviewers & Reaching Concurrence
• Process Flow and Metrics for Managing Regulatory Submissions

Course Completion

• Final Assessment
• Course Certification