Elite Institute Pharma Skills
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Diploma in Pharmacovigilance and Clinical Research 

  • Offered byElite Institute Pharma Skills

Diploma in Pharmacovigilance and Clinical Research
 at 
Elite Institute Pharma Skills 
Overview

A deep understanding of the processes involved in the development, monitoring, and regulation of pharmaceutical products, with a focus on ensuring the safety and efficacy of drugs and treatments

Duration

6 months

Mode of learning

Online

Official Website

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Credential

Certificate

Diploma in Pharmacovigilance and Clinical Research
 at 
Elite Institute Pharma Skills 
Highlights

  • Earn a diploma upon completion of course from Elite Institute Pharma Skills
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Diploma in Pharmacovigilance and Clinical Research
 at 
Elite Institute Pharma Skills 
Course details

Who should do this course?

Those with a background in pharmacology, biotechnology, biochemistry, or related fields who wish to specialize in pharmacovigilance or clinical research

Doctors, nurses, and pharmacists looking to transition into clinical research or pharmacovigilance roles

Individuals working in or aspiring to work in regulatory affairs and drug safety monitoring

 

What are the course deliverables?

Overview of pharmacovigilance and its role in drug safety.

Introduction to clinical research, phases of clinical trials (Phase I to IV), and the lifecycle of a clinical trial

Role of clinical research coordinators (CRCs), clinical research associates (CRAs), and principal investigators

 

More about this course

The Diploma in Pharmacovigilance and Clinical Research is a specialized program designed for individuals looking to build a career in the dynamic and critical fields of drug safety, clinical trials, and pharmaceutical research

This diploma program provides students with a deep understanding of the processes involved in the development, monitoring, and regulation of pharmaceutical products, with a focus on ensuring the safety and efficacy of drugs and treatments

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems

Diploma in Pharmacovigilance and Clinical Research
 at 
Elite Institute Pharma Skills 
Curriculum

Module 1: Introduction to Clinical Research & Advancement of ICH-GCP

Clinical Research in India

Phases of Clinical Trials

History & Background of Good Clinical Practice

Introduction to ICH, ICH-GCP Guideline & its advancement

 

Module 2: Ethical & Regulatory Aspects of Clinical Trials

Ethics Committee

Indian Council of Medical Research

Declaration of Helsinki

Drug & Cosmetic Act 1940, Schedule Y & its appendices

 

Module 3: Operations Aspects of Clinical Trials

Clinical Trial Design

Conduct of the study

Data Safety Monitoring Board (DSMB)

Clinical Data Management (CDM)

 

Module 4: Pharmacovigilance at Glance

Introduction to Pharmacovigilance

Pharmacovigilance-Glossary and related terms

Pharmacovigilance Methods

Pharmacovigilance Data Management and Case Processing

 

Module 5: Signal Management, ADR Reporting System & Dictionaries

Signal Identification, Development and Analysis

Adverse Drug Reaction Reporting System

Medical Dictionary for Regulatory Activities

WHO Drug Dictionary

 

Module 6: Regulatory Aspects of Pharmacovigilance

Different ICH & Other requirements for Drug Safety

Periodic Safety Update Report (PSUR)

Good Pharmacovigilance Practice (GPP)

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Diploma in Pharmacovigilance and Clinical Research
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Elite Institute Pharma Skills 

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