Diploma in Clinical Research & Pharmacovigilance

Categories: Advanced Programs
Includes 180 days access

Course Overview

Course Summary

The Advanced Diploma in Clinical Research & Pharmacovigilance (ADCR-PV) covers the core areas of the Clinical research and Pharmacovigilance processes and equips you to start a career as a Clinical Research or Drug Safety professional. The course is aligned to the requirements of the industry and imparts clinical research and pharmacovigilance process knowledge in a clear and concise manner so that you may kickstart a career in clinical research and pharmacovigilance. This program includes hands-on training modules on Oracle Siebel Clinical – CTMS for Clinical Research and Oracle Argus Safety for Pharmacovigilance.

Key Features

  • 24×7 access to the Oracle Siebel Clinical & Oracle Argus Safety software.
  • Full access to e-Learning Portal containing Multimedia Tutorials and Quizzes.
  • Course Instructor support via Discussion Forums

Curriculum

  • 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 – Principles of Pharmacovigilance
  • Module 20 – Pharmacovigilance and Selected System Organ Classes
  • Module 21 – Pharmacovigilance Systems
  • Module 22 – Global Pharmacovigilance and Safety Standards
  • Module 23 – Pharmacovigilance Regulations and Guidelines
  • Module 24 – Pharmacoepidemiology
  • Module 25 – Oracle Argus Safety Essentials
  • Course Completion

Certification

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

Duration:   6 months

Fees:  INR 49,999  (USD 899)

Submit a Comment

Your email address will not be published. Required fields are marked *