Clinical Development Sciences

PROGRAM DURATION

6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week

Advanced PG Diploma in Pharmacovigilance & Data Management

This comprehensive program of pharmacovigilance and clinical data management trains you on all key areas of pharmacovigilance and clinical data management with knowledge of Oracle Clinical data management software.

TOTAL CREDITS: 32

Next Commencement Date

15 DEC

2018

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INTRODUCTION

Why study this program?


Introduction

Pharmaceutical companies invest millions of dollars to develop new drugs, drugs that can help make lives of patients better and at the same time bring revenue for the company. When such big money is at stake it is only sensible to ensure at each step of development that the potential new drug is safe for human use. Further, once a drug has received regulatory approval for being marketed it is even more important for the company to keep monitoring its safety so that any reports of side effects can be evaluated and acted upon as per the applicable regulations. This is in the interest of the general population as the clinical trials that were conducted for the drug may not have been able to pick up some rare adverse events which can statistically only come to light once the drug is taken by a much larger number of individuals. Drug companies have dedicated teams of professionals working within their pharmacovigilance departments who track adverse events reported for each drug, enter the information in various databases, identify any signals and report the adverse events to regulatory agencies. This sector has grown immensely in the last decade due to the tightening of drug safety regulations by various regulatory agencies such as the US FDA and EMA; which has also resulted in a huge demand for pharmacovigilance professionals.

In the context of clinical trials, data management, simply put is the management of data generated by conducting clinical studies. Every clinical study that is conducted by a company is conducted in accordance to its study protocol and data required is collected via data collection tools such as case report forms. Once all the data is collected from the research sites it is entered in a data management system, cleaned to ensure that it is error free, and finally analysed to find out whether or not the hypotheses was correct. All this management of trial data is done by data management departments who use software's such as Oracle Clinical, Open Clinica and others to carry out the data management function. People with knowledge of clinical data management and those with training in data management software's are highly sought after in the industry. Job opportunities are plenty.

This program will give you a comprehensive understanding of both pharmacovigilance as well as clinical data management so that you can explore career opportunities in both these areas.

PROGRAM STRUCTURE

What will be taught?


Program Structure

MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 03: BASICS OF DRUG DEVELOPMENT
MODULE 04: PRINCIPLES OF PHARMACOVIGILANCE
MODULE 05: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 06: PHARMACOVIGILANCE SYSTEMS
MODULE 07: GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 08: PHARMACOVIGILANCE REGULATIONS & GUIDELINES
MODULE 09: PHARMACOEPIDEMIOLOGY
MODULE 10: BASICS OF CLINICAL DATA MANAGEMENT
MODULE 11: CLINICAL DATA MANAGEMENT PROCESSES & STANDARDS
MODULE 12: CLINICAL DATA MANAGEMENT SYSTEMS
MODULE 13: ORACLE CLINICAL

TOTAL CREDITS: 32

MODE OF STUDY: ONLINE

The curriculum for the program - The Advanced Post Graduate Diploma in Pharmacovigilance & Data Management (APGDP-DM) is extensive, has been developed and evaluated by experienced data management 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 pharmacovigilance and/or data management career, or those who wish to make a move to the pharmacovigilance or data management sector from any other related industry.

ASSESSMENT

How will I be assessed?


Assessment

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

ELIGIBILITY

Am I eligible?


Eligibility

The minimum eligibility criteria for Advanced Post Graduate Diploma in Pharmacovigilance & Data Management (APGDP-DM) 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
- Any degree in Computer Science / IT
- 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 / data management / allied areas. Please contact our admission representatives / counsellor to discuss your case.

ACADEMIC SUPPORT

What support will I receive?


Academic Support

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 Pharmacovigilance & Data Management Course is provided with a mentor who is an experienced professional from the industry. The mentor can be contacted at any time via email or phone.

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Program Fee

How much will it cost?
Please use our online fee calculator to calculate the fee applicable to you.



CAREER OPPORTUNITIES

Pharmacovigilance and Data Management are both areas that offer excellent career opportunities. Pharmaceutical companies, biotechnology companies, data management companies, CRO's, technology and IT consulting companies, all often employ data management and drug safety professionals. .


MORE INSIGHT

Both pharmacovigilance and data management have witnessed increased outsourcing year on year to developing countries that offer experienced and knowledgeable workforce and a lower operational cost. India, China, Brazil are examples of countries where data management and pharmacovigilance sectors are currently thriving. Some sponsor companies who have a large volume of work are also setting up their own operation's in these regions just to manage the backend data management and pharmacovigilance processes.


james lind institute
James Lind Institute (India) - Golden Square, 2nd floor # 579 32nd D Cross Road, 10th Main Rd, 4th Block, Jayanagar, Bengaluru 560011 | Phone: +91 40 42023318, +91-80-46473434
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