Diploma in Regulatory Affairs & Medical Writing

$799.00

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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.

 

Key Features

 

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

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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