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Advanced Post-Graduate Diploma in Clinical Research
and Pharmacovigilance

Online Pharmacovigilance Training | Pharmacovigilance Courses | Drug Safety Training Program

Online Pharmacovigilance Training | Pharmacovigilance Courses | Drug Safety Training

The pharmaceutical and biotech industry is revolutionizing in a manner where innovation and pharmacovigilance are not polarized. The business models are maturing to the next level of niche busters and towards a coexistence of novel and the age old blockbuster strategies.
Pharmacovigilance forms the backbone of the product life cycle due to a demand created by the need for new drugs and their regulation.
With the economic drift and emerging economies like India, China, Brazil and Russia, the pharmaceutical and biotech industry is shifting research and development towards these regions especially in the phases of clinical development.

A number of multinational companies like Pfizer, Novartis, Quintiles, GSK have set up pharmacovigilance centres in the major clinical research hubs worldwide, including India. In November 2004, the Indian ‘Central Drugs Standard Control Organization’ (CDSCO) launched the National Pharmacovigilance Program under the aegis of Directorate General of Health Services, Union Ministry of Health and Family Welfare.
Further, indigenous pharmaceutical and biotech companies in these regions are increasing their R&D efforts both for innovative molecules as well as the generic market. A market analysis conducted by Frost & Sullivan titled ‘World Pharmacovigilance Markets in Lifesciences’ finds that the pharmacovigilance market worldwide in 2008 was worth $1859.9 million and is estimated to reach $2252.2 million in 2015. This market report also stresses upon the evolving trend of major pharmaceutical companies to outsource/offshore their pharmacovigilance operations. There is a regular influx of this outsourcing activity in to the Indian market.
In the broader economic platform, a large number of clinical research management organizations have recently developed which include a range of full service CROs, early phase CROs, SMOs, companies with selective specialized services like data management and drug safety, clinical research consultancies, KPOs, etc
This has created a demand for skilled workforce in the clinical research industry as stressed in many business reports.

James Lind Institute is committed to developing emerging professionals for the clinical research industry who are equipped with the most relevant and latest knowledge and expertise.

The APGDCR-P course is an integrated course that will provide you with a systematic understanding of the core areas of the clinical research process and pharmacovigilance methodologies thus enhancing your skills and knowledge to the level expected of a Clinical Research and Pharmacovigilance Professional. Apart from clinical research management, this integrated course trains students to collate, analyze and archive adverse drug reaction data in order to make regulatory decisions regarding marketed drugs. Both these sectors of the industry are now creating large number of new job opportunities.

The APGDCR-P course curriculum is fully reviewed and endorsed by the Clinical Research Industry and the academia thus imparting students the edge that they require to make an entrance in the industry. It also empowers the professionals working in the clinical research industry with the skills and knowledge required to move to higher cadres of the management hierarchy.

Course Structure


    program curriculum

Course duration

Self Paced 6 - 8 months (Maximum duration 24 months)

A student enrolled for the Advanced Post Graduate Diploma in Clinical Research & Pharmacovigilance (APGDCR-P) Course is expected to study online for a minimum of fifteen hours per week.

Course Assessment

Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.

Overall academic performance in the program is measured on a 4 point Cumulative Grade Point Average (CGPA) scale. More information about this is available here: Evaluation System

Eligibility Criteria

The minimum eligibility criteria for the course would include either of the following:

  • MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.

  • Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.

  • Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).

  • Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.

  • Graduate or equivalent degree in Nursing/Allied Health.

  • Students in their final year of graduation for the above courses may also apply.

Fee Structure

Course fee for all JLI courses is very reasonable. Please use our Course Fee Calculator below to know the course fee applicable to you.

If you are not sure about the fee applicable to you for Advanced Post-Graduate Diploma in Clinical Research and Pharmacovigilance, please send an email to or chat with our online counsellor.

For more details about the admission procedure please click here.

Academic Support

Throughout the course, the students can interact with the faculty and other students via the “Online Campus Tutoring Centre” to discuss any coursework related issues.

Each student in the APGDCR-P course is assigned a mentor throughout the course who will be a senior professional from the Industry. Students are in close contact with the “Student Success Team” during the course and thereafter as alumni. To know more about the “Student Success Team”, click here

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