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Date 11-7-2021
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Time 6:00 PM -
Duration
2 hrs, 30 min
Pharmacovigilance (PV) Premium Plan
Our Pharmacovigilance training enhances career prospects by making students adept at ensuring drug safety, compliance and regulation. It open the doors for wide career oppurtunities such as Management profiles (Safety associates), Technical profiles (risk management, signal detection) and Pharmacoepidemology roles (PV scientists, risk management specilaists and Vigilance managers). Your future in the pharmacovigilance Awaits - Seize the oppurtunity and excel
Course offering
Curriculum
Introduction to Pharmacovigilance
History of Pharmacovigilance
World Health Organization Role in Pharmacovigilance
Pharmacovigilance Programme of India (PvPI)
Qualified Person for Pharmacovigilance
Definitions and Classification of ADRs
Detection and Reporting/Pharmacovigilance Reporting Methods (Sources) and Forms
Methods in Causality Assessment
Severity and Seriousness Assessment
Terminologies of Adverse Medication Related Events
Regulatory Terminologies
International Classification of Diseases (ICD)
Types of Databases in Pharmacovigilance
WHO Adverse Reaction Terminologies
MedDRA and Standardised MedDRA Queries
WHO Drug Dictionary
Eudravigilance Medicinal Product Dictionary
Pre-clinical Phase
Clinical Phase
Post approval Phase (PMS)
Investigational New Drug (IND) and New Drug Application (NDA) Program
Organization and objectives of ICH
Expedited Reporting
Individual Case Safety Report (ICSR)
Periodic Safety Update Reports (PSUR)
Post approval Expedited Reporting
Pharmacovigilance Planning
Good Clinical Practice in Pharmacovigilance Studies
Reporting Guidelines and Timelines
Periodic Adverse Drug Experience Report (PADER/PAER)
Annual Safety Report
Developmental Safety Update Report (DSUR)
Signal Detection in Pharmacovigilance
Code of Federal Regulations (CFR) - Title 21 Food and Drugs
Risk Management Process (RMP)
CIOMS Working Group
CIOMS Form
Pharmacovigilance Regulations and Guidelines
Regulatory Authorities in World
Case Scenario 1
Case Scenario 2
Case Scenario 3
Case Scenario 4
Case Scenario 5
Test Case 1
Test Case 2
Test Case 3
Test Case 4
Test Case 5
Real time Scenarios
Live Query session
Grand assessment Certificate
Description
Deep dive into Pharmacovigilance(PV) with our advanced program. Acquire enhanced knowledge on PV domain from basics to all aspects of PV with the additional add on case studies. Acquire sound professional knowledge with our advance PV course. Grow your professional potential with our wide range of programs from basics and additional add on case studies
Recorded Video
₹8000.0* /
₹16000.0
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Industry Expert:Yogesh Sharma
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LanguageEnglish
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CertificateYes