Advanced PG Diploma in Clinical Research & Pharmacovigilance

Key Facts

Duration
12 Months
Max. Duration
24 Months
Mode
Online
CREDITS
60 ECTS

Overview

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.

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.

Overview

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.

PROGRAM STRUCTURE

The program is comprised of 26 modules that can be completed in about 12 months. For a detailed list of modules covered in this program, please refer to the curriculum.

See Curriculum

Curriculum

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
MODULE 24: BASICS OF GOOD MEDICAL WRITING
MODULE 25: QUALITY & QUALITY MANAGEMENT
MODULE 26: THE QUALITY ASSURANCE FUNCTION

TOTAL CREDITS: 60

What is a credit?

A credit represents the amount of effort that is required to complete the program. Each module credit is equal to approximately 20 hours of study including lecture, tutorial, projects, assignment, field work etc. as may be applicable.

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 You Will Study

This program is conducted fully online.

Once you are enrolled you will be provided a username and password to login to our e-Campus. All the courses that you are supposed to study will be available in your account. You can log in and complete your courses at any time of your convenience. Study materials are provided in the form of lectures, reading materials, additional videos, research papers, and so on. The faculty can be contacted for any assistance when required. All tests and assignment submissions also take place via the e-Campus. For more information please refer to the online learning section of the website.

Important Dates

Next Start Date: 15 Aug 2022
Application Deadline: 12 Aug 2022

Assessments

  • Multiple Choice Questions

    Each lesson that you study online will be followed by a multiple choice question test. These usually comprise of 15 to 20 questions and can be attempted multiple times if needed. Pass percentage is 60%. The next unit in the sequence only unlocks once you have passed the test.

  • Project Work

    Each module is followed by a project or an assignment. This is like writing an essay in 1000 to 1500 words. The project topic and the guidelines to be followed will be available in your account.

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 can be contacted via personal messaging, emails, or phone, if required.

Towards the end of the program you will be provided placement assistance via our “Student Success Team”.

In addition, soon after enrolment, each participant registered in this 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 for career guidance.

Eligibility Requirements

The minimum eligibility criteria for this program 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, 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 this field. Please contact our admission representatives / counsellor to discuss your case.

Document Requirements
  • A passport size photo (head and shoulders only)
  • Copy of identity proof e.g. a copy of passport or any other government-issued identity card
  • Copy of bachelor’s degree or equivalent (degree/higher national diploma etc.)
  • Copy of academic transcripts/marks sheets from the bachelor’s degree
Language Requirements

This program is taught in English. Therefore, you should be comfortable in using English as a language of communication (reading, writing and speaking).

No proof is required.

 

How much does it cost?

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Career Opportunities

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..

Program FAQ's

This program can be completed in about 12 months. It is fully self-paced, so you can increase your pace or go slow based on your time availability.

The primary mode of learning is via pre-recorded lectures, videos, reading materials etc. A few live guest lectures are scheduled during the program however they are optional to attend. Whenever such sessions are scheduled they are planned in a way that is convenient for most of our students. If you are unable to attend, a reccorded version will be provided.

You will be able to interact with the faculty via the personal messaging facility available in your study account, discussion forum, or via emails. A short phone call can also be scheduled if necessary.

A discussion group is available for the program. You can post your questions in the group and other students may respond.

Generally, you do not need to purchase any books. All the resources that you need will be made available by the faculty in your account. If you do wish to have text books, then the faculty can recommend to you some, and you may purchase them on your own,

Each unit within each course will be followed by a short multiple-choice question test. Once you pass, the next unit will activate for you to study. You can take these tests as many times as you need to.

In addition, you will be required to submit assignments for each course. Assignments are like essay or paper writing, usually of 1000 – 1500 words. Guidelines on how to write them will be available in your account.

You can save the pdf study notes that will be provided for each unit. Videos and other multimedia content cannot be downloaded.

No, our degree does not mention that the program was conducted online.

At this time any graduation ceremony is not conducted for short duration programs like this one. Completion documents are sent to you by post or courier.

We recommend that you invest 10 to 15 hours per week in order to be able to complete within the prescribed program duration.

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