Diploma in Clinical Research & Regulatory Affairs

$799.00

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Description

 

The Advanced Diploma in Clinical Research & Regulatory Affairs (ADCR-RA) is an e-learning program designed to provide you a complete understanding of the core areas of clinical research and pharmaceutical regulatory affairs. It provides knowledge of global regulatory framework and develops skills required for regulatory strategy planning to ensure regulatory compliance. The course is aligned to the requirements of the industry and prepares you for the role of a regulatory affairs specialist for pre and post marketing studies. It includes hands-on training modules on Oracle Siebel Clinical – CTMS for Clinical Research and provides a comprehensive understanding of Pharmaceutical regulatory affairs.

This course provides 24×7 access to the Oracle Siebel Clinical – CTMS for hands-on practical learning.

 

Key Features

 

  • Full access to e-Learning Portal containing Multimedia Tutorials, Recorded Lectures and Quizzes.
  • 24×7 access to Oracle Siebel Clinical software
  • Course Instructor support via Discussion Forums

Curriculum

Course Stats – 35 Modules, 192 Chapters, 146 Quizzes

 

  • Module 1 – General Introduction
  • Module 2 – Epidemiology and Evidence Based Medicine
  • Module 3 – Pharmaceutical Medicine
  • Module 4 – Therapeutic Areas
  • Module 5 – Ethics in Clinical Research
  • Module 6 – Roles and Responsibilities
  • Module 7 – Clinical Trial Preparation
  • Module 8 – Essential Documents and Regulatory Submission
  • Module 9 – Study Start-up
  • Module 10 – Clinical Trial Monitoring
  • Module 11 – Compliance and Audits
  • Module 12 – Data Management and Biostatistics
  • Module 13 – Regulatory Affairs in Clinical Research
  • Module 14 – Medical Device Trials
  • Module 15 – Project and Vendor Management
  • Module 16 – Financial Management of Clinical Trials
  • Module 17 – Personality Development and Communication Skills
  • Module 18 – Oracle Siebel Clinical CTMS
  • Module 19 – Introduction to the Judicial System in India
  • Module 20 –  Drugs & Cosmetics Act and rules
  • Module 21 – Schedule Y
  • Module 22 – Indian Regulations governing Clinical Trials
  • Module 23 – Regulatory Regimen in US
  • Module 24 – European Medicines Agency (EMEA)
  • Module 25 – Regulations in Japan
  • Module 26 – In-Vitro and In-Vivo Pre-clinical studies
  • Module 27 – Efficacy Topics related to Clinical Studies
  • Module 28 – Common Technical Document (CTD)
  • Module 29 – IND and NDA requirements
  • Module 30 – CMC Information
  • Module 31 – Overview of GHTF
  • Module 32 – Regulatory processes for Medical Devices and Veterinary Products
  • Module 33 – Biosimilars EMEA Guidance and Regulations
  • Module 34 – Biopharmaceutical Indian Regulations and Guidelines
  • Module 35 – 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

 

The duration of this program is 6 months.

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