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Pharmacovigilance

Module I Pharmacovigilance
  • Introduction
  • Historical Overview
  • Basic principles of Pharmacovigilance in Clinical Trials
  • Methodologies for Pharmacovigilance
Module II Regulations in Pharmacovigilance in Clinical Research
  • FDA and EU perspectives
  • Drug Regulatory Activities MedDRA
  • Regulatory Aspects in Pharmacovigilance
  • EudraVigilance
  • Regulations in Pharmacovigilance in Clinical Research
Module III Adverse Drug Reactions and Safety Reports
  • ADR Reporting
  • Causality Assessment of Suspected Adverse Drugs Reactions
  • Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)
  • Expedited Reporting Requirements
  • Individual case safety reports
  • Periodic safety update reports
  • Electronic safety reporting
  • WHO & safety monitoring
Module IV Signal Analysis
  • Definition of signal and type of signal
  • Conducting signal detection in clinical and post marketing surveillance
  • Defining signal in relation to risk/benefit
  • Signal generation to decision making
  • Signal Detection Tools
  • Understanding signals & benefit risk determinations
Module V Compliance to Clinical Safety and Pharmacovigilance Regulations
  • Review of benefit-risk assessments and management
  • Scope of Pharmacovigilance inspection and conduct of inspection
  • Internal audit of pharmacovigilance activities of a company
  • Pharmacovigilance inspection reports
  • Pharmacovigilance compliance and inspection
  • Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections
  • Scope of Pharmacovigilance inspection and conduct of inspection
  • Internal audit of pharmacovigilance activities of a company
  • Key Functionalities of the Adverse Event Systems
  • Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections
Module VI Pharmacovigilance Management and Importance
  • Pharmacovigilance Database
  • Setting up a Pharmacovigilance Centre in Industry
  • Management of Pharmacovigilance Data
  • Risk Management in Pharmacovigilance
  • Data management & software solutions
  • Effective communication in pharmacovigilance
  • Pharmacovigilance in special situations
  • Pharmacovigilance capacity building

Programs in Pharmacovigilance

S.No

Course Details

Duration

Training Fee

Additional Support

Class

Online

1

Certificate Program

3-Months

20K

25K

  • Study Material
  • Training Certificate
  • Training with software facility
  • Resume Preparation
  • Soft Skills Development
  • Communication Skills Training

2

Internship Program

5-Months

40K

40K

  • Study Material
  • Training Certificate
  • Project work for 2 Months
  • Training with software facility
  • Resume Preparation
  • Soft Skills Development
  • Communication Skills Training

3

Job Oriented Program

6-Months

70K

No

  • Study Material
  • Experience Certificate
  • Training with software facility
  • Salary : 6K from 4 to 6th Month

4

Job Oriented Program

1-Year

200K

No

  • Study Material
  • Experience Certificate
  • Training with software facility
  • Salary : 7K from 4th to 12th Month