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 Start Date
Why study this program?
The drug development industry is changing in a way where innovation and drug safety are not separate from one another. New business models are maturing leading to the development of new generation therapies and to a coexistence of these newer drugs and well known blockbuster treatments from the past.
Pharmacovigilance is now an essential component of the life cycle of almost all healthcare related products. This is because of a demand for safer and more effective drugs and changes in regulations applicable to their research, development and marketing.
Many global companies such as Pfizer, Quintiles, GlaxoSmithkline etc have developed their own pharmacovigilance centres in all major clinical research regions around the world including India. In addition, local drug companies in these regions are also stepping up their work in research and development for both promising new molecules as well as generics. An industry analysis carried out by Frost & Sullivan titled ‘World Pharmacovigilance Markets in Lifesciences’ has found that the while the global pharmacovigilance industry in 2008 was valued at US $1859.9 million it is estimated to touch US $2252.2 million by 2015. This business report also emphasizes the shifting focus of key drug companies towards outsourcing their pharmacovigilance functions to smaller specialized pharmacovigilance service providers. Developing regions such as India, Latin America etc are slowly becoming a hub for pharmacovigilance business.
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the aegis of Directorate General of Health Services and the Union Ministry of Health and Family Welfare which has now been replaced by the Pharmacovigilance Program of India (PvPI) introduced in 2010.
This Advanced Pharmacovigilance Training Course is an integrated program that will give you a methodical understanding of the key areas of drug development, clinical research processes, clinical trial management, and pharmacovigilance systems thus boosting your skills and knowledge to the level expected of a Clinical Research and Pharmacovigilance Professional. In addition to clinical trial management, this Advanced Pharmacovigilance Training Program trains students to put together, evaluate and organize data related to drug side effects so as to make regulatory decisions pertaining to marketed drugs. Both clinical research and pharmacovigilance are now generating a significant number of new exciting career opportunities.
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?
You will be assessed on an ongoing basis by the faculty based on the following criteria:
One is the completion of the online multiple choice question tests that follow each lesson; and second is the timely submission of assignments for each study module within the JLI e-Campus.
Your academic performance in the program will be assessed on a 4 point GPA scale. More details about our evaluation system is available in the following link: Evaluation System
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?
As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC).
Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
In addition, each participant registered in the Advanced Post-Graduate Diploma in Clinical Research & Pharmacovigilance Course is provided with a mentor who is an experienced professional from the clinical research industry. The mentor can be contacted at any time via email or phone.
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James Lind Institute offers various masters degree programs in the areas of public health, business administration etc.
- MPH (with specializations)
- M.Sc in Health Mgmt
- MBA (various specializations)
For information on available masters programs via our School of Health Sciences; & our Business School click below:
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.