Description
The Advanced Diploma in Regulatory Affairs & Medical Writing (ADRA-MW) is an e-learning program 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.
Curriculum
Course Stats – 29 Modules, 111 Chapters, 110 Quizzes
- 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
The duration of this program is 6 months.
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