Diploma in Regulatory Affairs

Course Summary

The Professional Diploma in Regulatory Affairs (PDRA) is an eLearning Program that provides a thorough understanding of the various regulatory concepts and provide 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.

Key Features

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

Curriculum

• Module 1 – General Introduction
• Module 2 – Introduction to the Judicial System in India
• Module 3 – Drugs and Cosmetic Act and Rules
• Module 4 – Schedule Y
• Module 5 – Indian Regulations Governing Clinical Trials
• Module 6 – Regulatory Regime in US
• Module 7 – European Medicines Agency (EMEA)
• Module 8 – Regulations in Japan
• Module 9 – In-Vitro and In-Vivo Pre-clinical studies
• Module 10 – Efficacy Topics related to Clinical Studies
• Module 11 – Common Technical Document (CTD)
• Module 12 – IND and NDA Requirements
• Module 13 – CMC Information
• Module 14 – Overview of GHTF
• Module 15 – Regulatory Processes for Medical Devices and Veterinary Products
• Module 16 – Biosimilars EMEA Guidance and Regulations
• Module 17 – Biopharmaceutical Indian Regulations and Guidelines
• Module 18 – 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:   3 months