Industry Program in Clinical Trials and Data Management and Pharmacovigilance

Course Overview

With the globalization of the pharmaceutical industry there is an increased demand for organizational alignment to meet the regulatory requirements and stay ahead of the competition for faster commercialization of product. Clinical data management is the process of collection, minimizing the errors and organizing the data obtained from research & development carried out in various departments and checks its compliance with the specified regulatory standards. With recent report stating 50,000 clinical professionals are needed, the time is right to avail excellent opportunities in this filed, in India and world over.

Career Opportunities

“Clinical Data Management” is a profession with increasing importance in product research and development process and is considered as an integral part of clinical trials. A career in both Pharmaco-vigilance and Data Management is bright for the sincere and diligent student and the working professional. Career opportunities in Pharmaco-vigilance includes.

  • Clinical Pharmaco-vigilance Officer.
  • Clinical Pharmaco-vigilance Associate.
  • Regulatory Affairs Associate.
  • Clinical Drug Safety Associate and Clinical CRF Designer among others. For Data Management students, careers will be as Data Entry Operator, Research associates.
  • Data Coordinators and Statisticians.
  • Database Programmer.
  • Database Designer.
  • QA/QC Executive.
  • Project Manager.

Course Objectives

The main objective of this course is to develop experts/skilled professionals to perform clinical data management tasks by having a correct spatial orientation of clinical research data management. The course will help participants to acquire a basic understanding of the concepts and practice of pharmaco-vigilance. The aim of the course is to have thorough insight on project management related to pharmaco-vigilance / clinical data management domain. The regulatory perspectives of clinical trials & Pharmaco-vigilance are the important part of the course.

The course has been framed with the following objectives:

  • To enable students to understand issues surrounding the risks and benefits of drug used in humans including the cause, manifestations and consequences of adverse drug effects (ADEs).
  • To moulds both fresher as well as experienced candidates to become exceptional professionals in the arena of clinical research and pharmaco-vigilance.
  • To enable students to modulate their invisible resources (communication-oral and written, decision-making, leadership qualities and time management skills) and stay ahead in the fiercely competitive job market.
  • To equip them with the understanding of the regulatory perspectives on clinical research activities and give an insight into the functioning of pharmaco-vigilance and medical affair teams and their dependency on data management.
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Eligibility

Any Science Graduate

Examination Fees

Every student has to pay Rs.500/- per module as examination fees. Examination fee for overseas participants is USD 30 Per Module

Course Modules

  • Module 1

    Pharmacovigilance, Risk Management & Compliance to Clinical Safety.

  • Module 2

    Pharmacovigilance Regulation to Clinical Safety.

  • Module 3

    Adverse Drug Reactions, Reporting & Signal Detection System.

  • Module 4

    Bio-statistical Analysis of Clinical Trials Data.

  • Module 5

    Clinical Trials & Regulation Analysis.

  • Module 6

    Clinical Trials Data Management.

  • Module 7

    ICH-GCP Guidelines for Clinical Trials.

  • Module 8

    Contract Research.