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

01 SEP

2019

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INTRODUCTION

Why study this program?


Introduction

Pharmacovigilance (Drug safety) is a crucial aspect in the development of new drugs as well as the continued marketing of drugs available in the market. Pharmaceutical companies are required by law to ensure that the drugs that they develop are safe for the population and thus many steps are undertaken throughout the life cycle of a drug to ensure that safety data is collected, analysed and reported appropriately. The area of drug safety is coming up in a big way in developing countries while opportunities are also growing in developed countries. People trained in pharmacovigilance can explore career opportunities in pharmaceutical and biotechnology companies, pharma IT companies, and even regulatory agencies.

Clinical Data Management on the other hand plays a very important role in managing the huge amount of data that is obtained during clinical trials. Data management professionals ensure that the data is managed by means of specialized software's such as Oracle Clinical, Medidata Rave etc. so that the data is error free, accurate and ready for analysis by biostatisticians. Data management staff also develop the data management plan before data collection begins and develop various tools used by the research staff for collecting data. The data management staff works closely with the clinical operations department, medical writers, biostatisticians, regulatory affairs teams and many other functional teams. People trained in data management can explore careers in contract research organizations, pharmaceutical companies, pharma IT companies etc.


The APGDP-DM program has been developed keeping in mind the expectations of employers who frequently hire pharmacovigilance and data management professionals. The program is completely industry oriented and provides students with a stimulating learning experience, via the online study portal.

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

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

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

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 & Data Management Course (APGDPV-DM) 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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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.


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