The Advanced Diploma in Pharmacovigilance & Regulatory Affairs (ADPV-RA) is an e-learning program designed to provide students a complete understanding of Pharmacovigilance processes, regulations and documentation as well as the pharmaceutical regulatory affairs landscape. It equips you to start a career in Drug Safety or as a Regulatory Affairs specialist. The course is aligned to the requirements of the industry and includes hands-on training modules on Oracle Argus Safety for Pharmacovigilance.
This course provides 24×7 access to the Oracle Argus Safety for hands-on practical learning.
Course Stats – 26 Modules, 116 Chapters, 113 Quizzes
- Module 1 – General Introduction
- Module 2 – Epidemiology and Evidence Based Medicine
- Module 3 – Principles of Pharmacovigilance
- Module 4 – Pharmacovigilance and Selected System Organ Classes
- Module 5 – Pharmacovigilance Systems
- Module 6 – Global Pharmacovigilance and Safety Standards
- Module 7 – Pharmacovigilance Regulations and Guidelines
- Module 8 – Pharmacoepidemiology
- Module 9 – Oracle Argus Safety Essentials
- Module 10 – Introduction to the Judicial System in India
- Module 11 – Drugs and Cosmetic Act and Rules
- Module 12 – Schedule Y
- Module 13 – Indian Regulations Governing Clinical Trials
- Module 14 – Regulatory Regime in US
- Module 15 – European Medicines Agency (EMEA)
- Module 16 – Regulations in Japan
- Module 17 – In-Vitro and In-Vivo Pre-clinical studies
- Module 18 – Efficacy Topics related to Clinical Studies
- Module 19 – Common Technical Document (CTD)
- Module 20 – IND and NDA Requirements
- Module 21 – CMC Information
- Module 22 – Overview of GHTF
- Module 23 – Regulatory Processes for Medical Devices and Veterinary Products
- Module 24 – Biosimilars EMEA Guidance and Regulations
- Module 25 – Biopharmaceutical Indian Regulations and Guidelines
- Module 26 – Regulatory Strategic Planning, Interfacing and Corporate Communications
- Course Completion
At the end of the course, students will be awarded a certificate of completion.
The duration of this program is 6 months.