6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
This integrated program will give you a methodical understanding of the key areas of clinical research processes, management and pharmacovigilance systems thus boosting your skills to the level expected in the industry.
TOTAL CREDITS: 34
Next Commencement Date
Why study this program?
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.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY & EVIDENCE BASED MEDICINE
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: THERAPEUTIC AREAS
MODULE 05: ETHICS IN CLINICAL RESEARCH
MODULE 06: ROLES AND RESPONSIBILITIES
MODULE 07: CLINICAL TRIAL PREPARATION
MODULE 08: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 09: STUDY START-UP
MODULE 10: CLINICAL TRIALS 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: PRINCIPLES OF PHARMACOVIGILANCE
MODULE 19: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 20: PHARMACOVIGILANCE SYSTEMS
MODULE 21: GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 22: PHARMACOVIGILANCE REGULATIONS AND GUIDELINES
MODULE 23: PHARMACOEPIDEMIOLOGY
TOTAL CREDITS: 34
MODE OF STUDY: ONLINE
The curriculum for the program - Advanced Post Graduate Diploma in Clinical Research & Pharmacovigilance (APGDCR-P) is extensive, has been developed and evaluated by experienced industry professionals and is fully endorsed by the clinical research industry. Not only is this program suitable for new graduates but also for working professionals who either wish to grow further in their clinical research and/or pharmacovigilance career, or those who wish to make a move to the clinical research or pharmacovigilance sector from any other related industry.
How will I be assessed?
Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.
Am I eligible?
The minimum eligibility criteria for Advanced Post-Graduate Diploma in Clinical Research & Pharmacovigilance (APGDCR-P) would include either of the following:
- Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
- Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
- Any degree in Pharmacy / Pharmaceutical Sciences
- Any degree in Chemistry / Biostatistics / Bioinformatics
- Any degree in Nursing / Allied Health.
- Students in their final year of graduation for the above courses are also eligible to apply.
If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.
What support will I receive?
Throughout the course, the students can interact with the faculty and other students via the e-Campus to discuss any coursework related issues.
Each student enrolled in the Advanced Post-Graduate Diploma in Clinical Research & Pharmacovigilance Course (APGDCR-P) is also assigned a mentor throughout the course who will be a senior professional from the industry. Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
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This combination program of clinical research and pharmacovigilance will allow you explore career opportunities both related to clinical trials as well as those related to drug safety. Positions that can be explored include Clinical Research Associate, Clinical Research Coordinator, Drug Safety Associate, Case Processing Expert, Pharmacovigilance Executive etc..
At JLI we endeavor to develop clinical research and pharmacovigilance professionals who are equipped with the most relevant and up-to-date knowledge and skills. We achieve this goal through the diversity of our innovative and unique high quality online clinical research and pharmacovigilance training programs.