Course Summary

The Advanced Diploma in Regulatory Affairs & Medical Writing (ADRA-MW) is 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 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
• Module 19 – Basics of Good Medical Writing
• Module 20 – Computer Skills
• Module 21 – Overview of Regulatory, Marketing and Drug Promotion Process
• Module 22 – Common Technical Document
• Module 23 – Protocol, Investigator’s Brochure and CRFs
• Module 24 – Clinical Study Report
• Module 25 – Sentence Control
• Module 26 – Writing Flow and Cohesiveness
• Module 27 – Publication Writing
• Module 28 – Documents in Medico-Marketing
• Module 29 – Managing the Review Process
• Course Completion

Certification

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

Duration:   6 months