Diploma in Pharmacovigilance & Medical Writing

Curriculum

Course Stats – 20 Modules, 124 Chapters, 123 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 – 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