Concept Note
With the advent of more pharmaceutical companies looking at India for their pharmacovigilance activities, there is an imminent need to develop good professionals in pharmacovigilance.
ICRI, the largest clinical research institute in India and Accenture, a leader in clinical data management (CDM) and pharmacovigilance outsourcing have together developed a course titled "Post Graduate Diploma in Clinical Research & Pharmacovigilance". This course equips the students with the regulatory and industry aspects of pharmacovigilance. The modules have been designed to cover the basic topics like the biomedical basis of disease, bio-pharmaceutics and clinical research. The module additionally covers in detail topics on pharmacovigilance and its importance, end-to-end case processing basics and aggregate report writing. European, US and Indian regulations governing pharmacovigilance activities rounds off the program.
This course is designed in two different formats – a full time 6 month course and a 10 month weekend course. Both the courses aim to develop professionals in ICSR (individual case safety report) processing, aggregate report productions, signal detection and risk management plan. Each module will have theoretical sessions followed by practical classes. Practical sessions will include cases that give the student exposure to work done in the industry.
Course Duration: 6 Months Full-time / 10 Months Part-time
Eligibility: MBBS, BDS, B Pharma, M Pharma, B.Sc.(Botany), B.Sc.(Zoology) graduates
Course Offered at: Delhi, Mumbai and Bangalore campuses
| Course Modules | |
| Module I | Basics of Clinical Research, Pharmacology, Pharmacovigilance and Regulations |
| Module II | Case Processing(Introduction, Steps in Case Processing) |
| Module III | Aggregrate Report |
| Module IV | Risk Management and Signal Detection |
Contact Numbers
Delhi Campus
Email: delhi@icriindia.com
Phone: 011 - 4065 1000
Mumbai Campus
Email: mumbai@icriindia.com
Phone: 0091 022 – 42114949 / 4211 4910
Bangalore Campus
Email: bangalore@icriindia.com
Phone: 080 - 43577200 / 201 / 214 / 220 / 221
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