Diploma in Regulatory Affairs & Medical Writing

Curriculum

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

The curriculum progresses from regulatory foundations and global regulatory frameworks through drug-development requirements, regulatory submissions and strategy before moving into medical writing, clinical and regulatory documents, publication writing and scientific communications.

 

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 – 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 3 – 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 4 – Schedule Y

• Introduction, Amendments to Schedule Y
• Clinical Trials
• Studies in Special Population, Post Marketing Surveillance and Special Studies
• Appendices

Module 5 – Indian Regulations Governing Clinical Trials

• Regulatory Authorities in India
• Guidelines and important provisions
• Indian Regulatory Approval Process and approval timelines

Module 6 – Regulatory Regime in US

• Responsibilities of US FDA
• FDA Centers
• Code of Federal Regulations
• FDA guidelines for industry

Module 7 – European Medicines Agency (EMEA)

• Introduction, Roles and Responsibilities of EMEA
• Committees of EMEA
• EU Clinical Directives
• EUDRA CT

Module 8 – Regulations in Japan

• Organization and Function of MHLW (JAPAN)
• Pharmaceutical Laws and Regulations in Japan
• Drug Development in Japan

Module 9 – 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 10 – Efficacy Topics related to Clinical Studies

• Clinical Safety
• Dose Response Studies
• Clinical Evaluation

Module 11 – Common Technical Document (CTD)

• General principles of CTD
• Modules with Diagrammatic representation
• eCTD

Module 12 – IND and NDA Requirements

• IND and NDA applications in U.S
• IND and NDA Applications in India

Module 13 – CMC Information

• CMC for Phase I
• CMC for Phase II and III

Module 14 – Overview of GHTF

• Organization
• Study Groups and Documents

Module 15 – Regulatory Processes for Medical Devices and Veterinary Products

• U.S Scenario
• Indian Scenario

Module 16 – Biosimilars EMEA Guidance and Regulations

• Guidelines and Applications of Biosimilars
• Specific Guidelines

Module 17 – Biopharmaceutical Indian Regulations and Guidelines

• Regulatory Bodies
• Guidelines for Pre-Clinical and Clinical studies

Module 18 – Regulatory Strategic Planning, Interfacing and Corporate Communications

• Regulatory Strategic Planning
• Corporate Communications

Module 19 – Basics of Good Medical Writing

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

Module 20 – Computer Skills

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

Module 21 – 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 22 – 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 23 – 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 24 – Clinical Study Report

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

Module 25 – 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 26 – Writing Flow and Cohesiveness

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

Module 27 – 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 28 – 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 29 – 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