Diploma in Clinical Research & Pharmacovigilance

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