6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
This program provides you with a thorough understanding of the core concepts of drug safety such as signal detection, post marketing surveillance, adverse event reporting and also introduces you to clinical research quality assurance.
TOTAL CREDITS: 32
Next Commencement Date
Why study this program?
Pharmacovigilance is a field of science that primarily deals with determining, verifying, quantifying, analyzing and reducing the ill effects of medical drugs, devices or biologicals, thus increasing their safety.
Pharmacovigilance is an anchor throughout the life cycle of new drugs and devices due to a demand created by the requirement of new medical treatments and their legislation.
With the global financial drift and the promise shown by emerging nations such as India, China, Brazil and Russia, the drug development industry is moving its R & D and pharmacovigilance activities towards these regions for better efficiency and cost savings.
At the core of the drug development process is the area of quality assurance. Maintaining Quality throughout the clinical study is a continual dynamic process. Quality Assurance system encompasses all quality control activity and acts as a link between the monitoring activities and the regulatory inspection. Quality assurance helps achieving standardization and maintaining reliability at every stage of clinical trial process. Quality Assurance (QA) activities include planning, scheduling conducting audits and evaluation of quality level & compliance with GCP guidelines and applicable regulations.
Advanced Postgraduate Diploma in Pharmacovigilance and Quality Assurance (APGDP-QA) program is devised to meet increasing demand by industry for drug safety and quality assurance professionals. APGDP+QA program is carefully designed by the experienced faculty from the industry, especially to provide understanding of core quality assurance methods, process and practices. The program enables the professional to develop a solid foundation in pharmacovigilance and helps to cultivate advance skills and competence to manage and deliver quality systems and quality results. The Advanced Postgraduate Diploma in Pharmacovigilance and Quality Assurance program will give you a broad range of choice for your next steps, right from advancing your career to pursuing further research and professional development activities and to become a skilled Quality Assurance Auditor & Professional.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 03: PRINCIPLES OF PHARMACOVIGILANCE
MODULE 04: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 05: PHARMACOVIGILANCE SYSTEMS
MODULE 06: GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 07: PHARMACOVIGILANCE REGULATIONS & GUIDELINES
MODULE 08: PHARMACOEPIDEMIOLOGY
MODULE 09: QUALITY & QUALITY MANAGEMENT
MODULE 10: THE QUALITY ASSURANCE FUNCTION
MODULE 11: AUDITS
MODULE 12: QUALITY GUIDELINES
MODULE 13: GCP/GMP/GLP
TOTAL CREDITS: 32
MODE OF STUDY: ONLINE
The curriculum for the program - The Advanced Post Graduate Diploma in Pharmacovigilance & Quality Assurance (APGDP-QA) is extensive, has been developed and evaluated by experienced pharmacovigilance and quality assurance professionals and is fully endorsed by the industry. Not only is this program suitable for new graduates but also for working professionals who either wish to grow further in their pharmacovigilance or quality assurance career, or those who wish to make a move to these sectors 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 Pharmacovigilance & Quality Assurance (APGDP-QA) 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 / quality assurance / 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 Pharmacovigilance & Quality Assurance Course (APGDPV-QA) 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 is a perfect program those who are inclined towards both drug safety as well as clinical quality assurance. This unique program allows students to study both these areas in detail and explore career opportunities related to both. Participants can find opportunities with pharmaceutical companies, CRO's, pharmacovigilance companies, consulting agencies, auditing firms and many similar organizations. Positions related to pharmacovigilance that can be explored include Drug Safety Associate, Drug Safety Coordinator, Drug Safety Scientist, Case Processing Expert etc. Positions related to QA are Quality Assurance Executive, Quality Assurance Associate, Quality Assurance Manager among many others..
Both pharmacovigilance and quality assurance offer excellent career growth. With a few years of work experience people who perform well can move to managerial and senior managerial roles such as Team Leader or Head of Department. People with good people management skills can also move to senior management to roles such as Director and Senior Director.