Diploma in Pharmacovigilance & Regulatory Affairs

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