Diploma in Regulatory Affairs & Medical Writing

$899.00

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Description

 

The Advanced Diploma in Regulatory Affairs & Medical Writing (ADRA-MW) is an e-learning program designed to provide students a complete understanding of clinical trial regulations, regulatory documents created during the clinical trial process and tasks of performing medical writing for these documents. It equips you to start a career in Regulatory Affairs specialist or as a Medical writer. The course is aligned to the requirements of the industry.

 

Key Features

 

  • Full access to e-Learning Portal containing Multimedia Tutorials, Recorded Lectures and Quizzes.
  • Course Instructor support via Discussion Forums

Curriculum

Course Stats – 29 Modules, 111 Chapters, 110 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 – 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

Certification

 

At the end of the course, students will be awarded a certificate of completion.

Duration

 

The duration of this program is 6 months.

You will have access to the course on the learning portal, for the duration of the program.

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