Diploma in Pharmacovigilance & Regulatory Affairs

Categories: Advanced Programs
Includes 180 days access

Course Overview

Course Summary

The Advanced Diploma in Pharmacovigilance & Regulatory Affairs (ADPV-RA) is designed to provide students a complete understanding of Pharmacovigilance processes, regulations and documentation as well as the pharmaceutical regulatory affairs landscape. It equips you to start a career in Drug Safety or as a Regulatory Affairs specialist. The course is aligned to the requirements of the industry and includes hands-on training modules on Oracle Argus Safety for Pharmacovigilance.

Key Features

  • 24×7 access to the Oracle Argus Safety software.
  • Full access to e-Learning Portal containing Multimedia Tutorials and Quizzes.
  • Course Instructor support via Discussion Forums

Curriculum

  • Module 1 – General Introduction
  • Module 2 – Epidemiology and Evidence Based Medicine
  • Module 3 – Principles of Pharmacovigilance
  • Module 4 – Pharmacovigilance and Selected System Organ Classes
  • Module 5 – Pharmacovigilance Systems
  • Module 6 – Global Pharmacovigilance and Safety Standards
  • Module 7 – Pharmacovigilance Regulations and Guidelines
  • Module 8 – Pharmacoepidemiology
  • Module 9 – Oracle Argus Safety Essentials
  • Module 10 – Introduction to the Judicial System in India
  • Module 11 – Drugs and Cosmetic Act and Rules
  • Module 12 – Schedule Y
  • Module 13 – Indian Regulations Governing Clinical Trials
  • Module 14 – Regulatory Regime in US
  • Module 15 – European Medicines Agency (EMEA)
  • Module 16 – Regulations in Japan
  • Module 17 – In-Vitro and In-Vivo Pre-clinical studies
  • Module 18 – Efficacy Topics related to Clinical Studies
  • Module 19 – Common Technical Document (CTD)
  • Module 20 – IND and NDA Requirements
  • Module 21 – CMC Information
  • Module 22 – Overview of GHTF
  • Module 23 – Regulatory Processes for Medical Devices and Veterinary Products
  • Module 24 – Biosimilars EMEA Guidance and Regulations
  • Module 25 – Biopharmaceutical Indian Regulations and Guidelines
  • Module 26 – Regulatory Strategic Planning, Interfacing and Corporate Communications
  • Course Completion

Certification

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

Duration:   6 months

Fees:  INR 49,999  (USD 799)

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