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Advanced PG Diploma in Clinical Research & Pharmacovigilance

PROGRAM DURATION

6 Months 
Maximum Allowed Duration:  6 Months

This comprehensive training will give you a methodical understanding of the key areas of the procedures, management and pharmacovigilance structures in clinical research, thereby upgrading your skills to the level expected in the industry.

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Fee: 19999/-

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Introduction

Advanced PG Diploma in Clinical Research & Pharmacovigilance

Introduction

The drug development industry is changing in a way where innovation and drug safety are not separate from one another. New business models are maturing leading to the development of new generation therapies and to a coexistence of these newer drugs and well known blockbuster treatments from the past.

Pharmacovigilance is now an essential component of the life cycle of almost all healthcare related products. This is because of a demand for safer and more effective drugs and changes in regulations applicable to their research, development and marketing

Several global companies have established their own pharmacovigilance centers in all major clinical research regions around the world, including India, such as Pfizer, Quintiles, GlaxoSmithkline etc. In addition, local drug firms are also stepping up their research and development work in these regions for both promising new molecules as well as generic ones.

An market study conducted by Frost & Sullivan entitled’ Global Pharmacovigilance Markets in Lifesciences’ found that while the global pharmacovigilance industry was valued at US$ 1859.9 million in 2008, it is projected that it will hit US$ 2252.2 million in 2015.

The market study further underlines main drug companies ‘ shifting focus on outsourcing their pharmacovigilance functions to smaller specialist pharmacovigilance service providers. Developing regions like India, Latin America and so on are slowly becoming a center for pharmacovigilance companies.

The Indian’ Central Drugs Standard Control Organization’ (CDSCO) initiated the National Pharmacovigilance Program in November 2004, under the auspices of the Directorate-General for Health Services and the Union Ministry of Health and Family Welfare, which was now replaced by India’s Pharmacovigilance Program (PvPI) launched in 2010.

This Advanced Pharmacovigilance Training Course is an interactive curriculum that will provide you with a methodical understanding of the key areas of drug development, clinical research methods, clinical trial management, and pharmacovigilance programs, thus improving your skills and knowledge to the level expected of a Clinical Research and Pharmacovigilance Professional.

In addition to the administration of clinical trials, this Advanced Pharmacovigilance Training Program trains students to collect, analyze and coordinate data related to drug side effects in order to make legal decisions regarding branded drugs. Both clinical research and pharmacovigilance today create a considerable number of exciting new career opportunities.

Course Objectives :

  • To provide a comprehensive introduction to the clinical research process.
  • Learn the skills, knowledge and competencies of a candidate for the Clinical Research Associate and Pharmacovigilance jobs.
  • Become more familiar with roles/jobs as part of the study team.
  • Basic concepts, importance of Pharmacovigilance and Global Pharmacovigilance regulations.
  • Practical aspects of important Pharmacovigilance activities as per the global standards
    like medical evaluation, casualty assessment, expectedness assessment, case narratives,MedDRA, case processing preparation of safety report etc.

Program Structure

Advanced PG Diploma in Clinical Research & Pharmacovigilance

MODULE -1

  1. Introduction to Clinical Research & Good Clinical Practice
  2. Overview ICH GCP
  3. Good Clinical practice
  4. Clinical Trails
  5. Institutional Reviews board
  6. Investigation Responsibilities in clinical trails
  7. Roles and Responsibilities of Sponsor & Clinical Trial Monitor
  8. Informed Consent Process
  9. Serious Adverse Event (SAE), Adverse event reporting
  10. Site Initiation visit
  11. Site close visit
  12. Test Your Self
  13. Apply Your Certificate

MODULE -2

  1. Introduction to Pharmacoviginalce
  2. The history of PV
  3.  The Burden Of Adrs And The Need For Pv
  4. Aims Of Pv
  5. The Scope Of Pv Part 1,2,3
  6. What Is A Signal, When Does Signal Detection Start & Why Do We Need Signal Detection
  7. Where Can We Find Signals, What Triggers A Signal, How Do We Assess A Signal
  8. Statistical Reasoning And Algorithms In Pv, Dis-proportionality, Relative Reporting Ratio (Rr)
  9.  Random Variability, Decision Rules,Aspects Of Strength Of Evidence, A Cautionary Note
  10.  Medical Dictionary for Drug Regulatory Activities (MedDRA)
  11.  Individual Case Safety Reports (Icsrs)
  12.  Periodic safety update report (PSUR)
  13. Dsur Vs Psur in Pharmacovigilance

MODE OF STUDY

Advanced PG Diploma in Clinical Research & Pharmacovigilance

MODE OF STUDY: ONLINE / E-LEARNING

The program curriculum-Advanced Postgraduate Diploma in Clinical Research & Pharmacovigilance (APGDCR-P) is comprehensive, has been developed and validated by seasoned industry professionals, and has been fully endorsed by the clinical research community. The curriculum is ideal not only for new graduates, but also for working professionals who either wish to grow further in their clinical research and/or pharmacovigilance field or who wish to move from any other related industry into the clinical research or pharmacovigilance market.

Assessment

Assessment

The faculty will judge you on an ongoing basis on the basis of the following criteria: one is completing the electronic multiple choice query assessments that accompany each lesson; and the second is the prompt submission of assignments within the PHARMA RESEARCH e-Campus for each research class.

Your academic performance at the school will be measured on a GPA scale of 4 grades.

Eligibility

Advanced PG Diploma in Clinical Research & Pharmacovigilance

Eligibility

The minimum eligibility criteria for Advanced Post-Graduate Diploma in Clinical Research & Pharmacovigilance (APGDCR-P) 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 / allied areas. Please contact our admission representatives / counsellor to discuss your case.

Academic Support

Academic Support

You can connect online as a student to network with faculty members and fellow students and discuss important topics through your e-campus. The staff reacts promptly to all study-related questions within the Online Campus Tutoring Center (OCTC). 

You will be provided with placement assistance and career development support via the “Student Success Group” by the end of the program as necessary. 
Furthermore, each participant enrolled in the Advanced Post-Graduate Diploma in Clinical Research & Pharmacovigilance Course receives a mentor who is an accomplished clinical research industry specialist. The tutor can be reached by e-mail or by phone at any time.

QUALITY PROGRAM

At PHARMA RESEARCH we strive to develop clinical research and pharmacovigilance professionals who are equipped with the most up-to-date and relevant knowledge and skills. This goal is accomplished through the breadth of our innovative and unique online high-quality clinical research and pharmacovigilance training programs.