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Presented By
Nipun Gupta 810501
Ankush 810512
Naveen 810499
Sudhir 810486
Sumit 810509
B. Pharmacy 8th Semester
2017-2021
Under the Supervision of
Mrs. Roopal Mittal
Assistant Professor (Pharmacology)
R.K.S.D. College of Pharmacy, Kaithal (Haryana)
 Pharmacovigilance
 Pathway of PvPI
 Establishment of PV Programme in Hospital
 Data Acquisition
 Constitution and Functioning
 Role of PV in Hospital
 Establishment of PV Programme in Industry
 Aim
 Scientific Character
 Pre marketing Surveillance
 Post Marketing Surveillance
 Contract Research Organization
 Identification and Selection
 Function of CRO
 Establishment a National Programme
 Organization
 Function
 Communication Process and flow of ADR
Contents
Pharmacovigilance Science and activities relating to the
 Detection
 Assessment
 Understanding
 Prevention
of adverse drug reaction or any other possible drug related problems
HISTORY AND DEVELOPMENT
1986 Initiation of PvPI by Name of ADRs Monitoring System
(12 regional center) under supervision of DCGI
1998 India Join WHO PIDM
2005 National Programme for PV launch
2010 PvPI come in force with NCC, AIIMS as well as 22 AMC
2011 NCC, AIIMS transferred to IPC, Ghaziabad
2017 250+ ADR monitoring center
Pathway Of PvPI
Data acquisition
Dissemination
Establishment
Internal education
Database
Promotion
Networking
Manpower and the Machinery
Funding
Basic Requirement
Patient
ADE Monitoring
Suspected Medicines
Other Medicines
Risk Factors
Reporter
Data Acquisition/CRF
Reports of Suspected ADRs are taken in case report form CRF which include
minimum following Information
Constitution and Functioning
Role of PV in Hospital
Role of
PV in
Hospitals
Informatio
n Service
Reachi
ng out
Appraisal
Secondar
y
preventio
n of ADRs
Data
Processi
ng
Hypothesizi
ng
Medicine
Regulatio
n
Improve patient care and safety in relation to use of medicine
Protect patient from unnecessary harm by previously unrecognized drug
hazards
Elucidating pre disposing factors
Refuting false safety signal
To quantifying risk in relation to benefit
Aim
Scientific Characteristics
Clinical & Pre-Clinical
Pharmacology
Immunology
Toxicology
Epidemiology
Pre-Marketing Pharmacovigilance
Clinical Trials
Phase 1
• Human
Pharmacology
• Safety,
PK,Tolerability
• 20-100
Healthy
Volunteer
Phase 2
• Therapeutic
Exploratory
• Safety,
Efficacy
• 100-500
patient
Phase 3
• Therapeutic
Confirmatory
• Safety,
Efficacy
• 1000-5000
patient
Post Marketing Surveillance
Spontaneous Reporting
Unsolicited communication by healthcare professionals or consumers to a
company, regulatory authority or other organisation (e.g., WHO, CDSCO etc.)
that describes one or more adverse drug reactions in a patient who was given
one or more medicinal products
Targeted Spontaneous Reporting
To learn more about the ADR profile of specific medicine(s) in your
population Or To estimate the incidence of a known ADR to a specific
medicine in your population
Cohort Study
Cohort study of adverse events associated with one or more monitored medicines.
It is related to class of medicine that has previously caused ADRs Potentially
significant adverse event observed during post-marketing surveillance
Like Retrospective, Prospective
Ensure patient safety and
product efficacy
Part of the solution in healthcare delivery
Embrace rnulli0lJannel strategy and digital systems
Drive patient-centric approaches
A new plan for effective Implementation of Pharmacovigilance in the Industry
Future Goal
CONTRACT RESEARCH ORGANISATION
A CRO is an organisation contracted by another company to manage and lead the
company's trials, duties and functions.
CRO Identification and Selection
 Preparing study designs for each of the research studies to be outsourced.
 Determining which CROs should be considered as potential contractors.
 Soliciting cost and time proposals which include determining if the CROs understands
the study design and selecting those CRO to be consider further.
 Scheduling and conducting site visits to ensure the CROs are qualified.
 Negotiating time and cost for completion of research studies.
 Selecting the CROs and awarding the contracts for each study to be outsourced.
Function of CRO
CRO
Project
Initiation
Concept and
feasibility
Product
Development and
Pre Clinical Testing
Prototyping,
Development,
Validation,
Bench test etc.
Clinical Trial
Protocol
Development,
Initiation &
Monitoring,
Investigation,
Data analysis,
Reporting
Regulatory
Submission
Post-
Marketing
Surveillance
Monitoring
Indian
Pharmacopoeia
Commission
NCC PvPI
CDSCO
Headquarter
New Delhi
AEFI and
ITSU
MoHFW
NIB
MoHFW
Noida
Uppsala
Monitoring
Centre,
Sweden
Adverse
Drug
Monitoring
Centre
WHO India
(Country
Office)
National
Health
Programme
MoHFW
Govt. of
India
Establishment of National Pharmacovigilance
Programme
Organization
Functions
Establishment of Pharmacovigilance Programme
Establishment of Pharmacovigilance Programme
Establishment of Pharmacovigilance Programme

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Establishment of Pharmacovigilance Programme

  • 1. Presented By Nipun Gupta 810501 Ankush 810512 Naveen 810499 Sudhir 810486 Sumit 810509 B. Pharmacy 8th Semester 2017-2021 Under the Supervision of Mrs. Roopal Mittal Assistant Professor (Pharmacology) R.K.S.D. College of Pharmacy, Kaithal (Haryana)
  • 2.  Pharmacovigilance  Pathway of PvPI  Establishment of PV Programme in Hospital  Data Acquisition  Constitution and Functioning  Role of PV in Hospital  Establishment of PV Programme in Industry  Aim  Scientific Character  Pre marketing Surveillance  Post Marketing Surveillance  Contract Research Organization  Identification and Selection  Function of CRO  Establishment a National Programme  Organization  Function  Communication Process and flow of ADR Contents
  • 3. Pharmacovigilance Science and activities relating to the  Detection  Assessment  Understanding  Prevention of adverse drug reaction or any other possible drug related problems
  • 4. HISTORY AND DEVELOPMENT 1986 Initiation of PvPI by Name of ADRs Monitoring System (12 regional center) under supervision of DCGI 1998 India Join WHO PIDM 2005 National Programme for PV launch 2010 PvPI come in force with NCC, AIIMS as well as 22 AMC 2011 NCC, AIIMS transferred to IPC, Ghaziabad 2017 250+ ADR monitoring center
  • 7. Patient ADE Monitoring Suspected Medicines Other Medicines Risk Factors Reporter Data Acquisition/CRF Reports of Suspected ADRs are taken in case report form CRF which include minimum following Information
  • 9. Role of PV in Hospital Role of PV in Hospitals Informatio n Service Reachi ng out Appraisal Secondar y preventio n of ADRs Data Processi ng Hypothesizi ng Medicine Regulatio n
  • 10. Improve patient care and safety in relation to use of medicine Protect patient from unnecessary harm by previously unrecognized drug hazards Elucidating pre disposing factors Refuting false safety signal To quantifying risk in relation to benefit Aim
  • 11. Scientific Characteristics Clinical & Pre-Clinical Pharmacology Immunology Toxicology Epidemiology
  • 12. Pre-Marketing Pharmacovigilance Clinical Trials Phase 1 • Human Pharmacology • Safety, PK,Tolerability • 20-100 Healthy Volunteer Phase 2 • Therapeutic Exploratory • Safety, Efficacy • 100-500 patient Phase 3 • Therapeutic Confirmatory • Safety, Efficacy • 1000-5000 patient
  • 13. Post Marketing Surveillance Spontaneous Reporting Unsolicited communication by healthcare professionals or consumers to a company, regulatory authority or other organisation (e.g., WHO, CDSCO etc.) that describes one or more adverse drug reactions in a patient who was given one or more medicinal products Targeted Spontaneous Reporting To learn more about the ADR profile of specific medicine(s) in your population Or To estimate the incidence of a known ADR to a specific medicine in your population Cohort Study Cohort study of adverse events associated with one or more monitored medicines. It is related to class of medicine that has previously caused ADRs Potentially significant adverse event observed during post-marketing surveillance Like Retrospective, Prospective
  • 14. Ensure patient safety and product efficacy Part of the solution in healthcare delivery Embrace rnulli0lJannel strategy and digital systems Drive patient-centric approaches A new plan for effective Implementation of Pharmacovigilance in the Industry Future Goal
  • 15. CONTRACT RESEARCH ORGANISATION A CRO is an organisation contracted by another company to manage and lead the company's trials, duties and functions. CRO Identification and Selection  Preparing study designs for each of the research studies to be outsourced.  Determining which CROs should be considered as potential contractors.  Soliciting cost and time proposals which include determining if the CROs understands the study design and selecting those CRO to be consider further.  Scheduling and conducting site visits to ensure the CROs are qualified.  Negotiating time and cost for completion of research studies.  Selecting the CROs and awarding the contracts for each study to be outsourced.
  • 16. Function of CRO CRO Project Initiation Concept and feasibility Product Development and Pre Clinical Testing Prototyping, Development, Validation, Bench test etc. Clinical Trial Protocol Development, Initiation & Monitoring, Investigation, Data analysis, Reporting Regulatory Submission Post- Marketing Surveillance Monitoring
  • 17. Indian Pharmacopoeia Commission NCC PvPI CDSCO Headquarter New Delhi AEFI and ITSU MoHFW NIB MoHFW Noida Uppsala Monitoring Centre, Sweden Adverse Drug Monitoring Centre WHO India (Country Office) National Health Programme MoHFW Govt. of India Establishment of National Pharmacovigilance Programme Organization