Diploma in Regulatory Affairs

$299.00

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Description

 

The Professional Diploma in Regulatory Affairs (PDRA) is an online eLearning course that provides a thorough understanding of the various regulatory concepts and provides expertise in the field of regulatory affairs documentation and research. The course provides the knowledge you need to effectively manage the regulatory process during Innovation, Discovery, Approval and Commercialization stages of the drug.

The Diploma in Regulatory Affairs is made up of 18 modules, 55 topics and 56 Quizzes. It lays a strong foundation by covering the various regulations and guidelines across different regulatory authorities including United States, European Union, Japan and India.

The course covers in detail, the regulations governing Clinical trials, Drugs and Cosmetic Act, Schedule Y, and the regulations across different regulatory bodies. The course also covers Common technical Document, IND and NDA requirements for submission and the regulatory guidelines for Biopharmaceutical, Medical devices and Veterinary products.

On completing your enrolment for the Diploma in Regulatory Affairs program you will instantly get access to the course on our online learning portal.

Find more information about the field of Regulatory Affairs – What is Regulatory Affairs

Key Features

 

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

Curriculum

Course Stats – 18 Modules, 55 Chapters, 56 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
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 3 months.

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

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