SlideShare uma empresa Scribd logo
1 de 65
Pharmacovigilance Workshop
Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is Pharmacovigilance? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Objectives of Pharmacovigilance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],? ? ? ? ? ?
From test tube to the market –  PRECLINICAL RESEARCH SYNTHESIS CANDIDATES SAFETY, TOLERABILITY & PHARMACOKINETICS Toxicity testing ,  reproductive toxicology,   carcinogenicity, genotoxicity, toxicokinetics  DRUG SCREENING activity & selectivity = Pharmacological profile
From test tube to the market –  CLINICAL RESEARCH PHASE I PHASE III PHASE II “ First-in-Man Trial” Pharmacokinetics Metabolism  Pharmacology Safety (early effectiveness) 20-80 HEALTHY VOLUNTEERS Preliminary data on efficacy for a particular indication(s)  Short-term Adverse Drug Reactions Dose range SEVERAL HUNDRED PATIENTS WITH DISEASES OR CONDITION SEVERAL HUNDRED TO THOUSAND PATIENTS Efficacy and safety for overall benefit-risk assessment Product information APPROVAL
? Limitations of Clinical Study Data ? Variable (compliance?) Fixed Dose Flexible; less information Rigorous; more information Conditions Usually present Avoided Concomitant medication and illness All Pregnant, children, elderly excluded Population Years Weeks Duration Thousands to millions Hundreds (rarely thousands) Number of patients Clinical Practice Clinical trials
Drug Safety Information Formulation (STRUCTURE ACTIVITY RELATIONSHIP) Preclinical studies  (TOXICOLOGY, PHARMACOLOGY, PHARMACOKINETICS) Clinical studies  (IDENTIFICATION OF ADRs, CHARACTERISATION, CAUSALITY, FREQUENCY, MANAGING) Pre marketing RARE ADRs? CHRONIC USE? DELAYED ADRs? INTERACTIONS? CHILDREN/ELDERLY?
From test tube to the market –  CLINICAL RESEARCH PHASE I PHASE III PHASE II “ First-in-Man Trial” Pharmacokinetics Metabolism  Pharmacology Safety (early effectiveness) 20-80 HEALTHY VOLUNTEERS Preliminary data on efficacy for a particular indication(s)  Short-term Adverse Drug Reactions Dose range SEVERAL HUNDRED PATIENTS WITH DISEASES OR CONDITION SEVERAL HUNDRED TO THOUSAND PATIENTS Efficacy and safety for overall benefit-risk assessment Product information APPROVAL POSTMARKETING SURVEILLANCE
Postmarketing surveillance ,[object Object],[object Object]
Postmarketing surveillance   TOOLS FOR COLLECTION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Withdrawals from the market as a result of spontaneous reporting 1998 1997 Serious hepatotoxic effect bromfenac 1998 1985 Fatal cardiac arrythmias terfenadine 1992 1992 Haemolytic anemia temafloxacin 1991 1987 Excessive mortality encainide 1982 1982 Onycholysis, renal, liver, bone marrow toxicity benoxaprofen 1975 1970 Blindness practolol Year of withdrawal Year of approval Reason for withdrawal INN
[object Object],! ! ! ! ! !
Histor ical Background ,[object Object],[object Object],[object Object],[object Object]
Histor ical Background ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object]
The Concept of Pharmacovigilance System
Pharmacovigilance – concerned parties Competent Authorities  (National Agencies, European Medicines Agency) Healthcare Professionals: Voluntary reporting or Mandatory reporting WHO Pharmaceutical Industry  (Marketing Authorisation Holder &  Sponsor of Clinical Trials) Patients: Complain or Complain & Report
Collect Identify Evaluate Take action INDIVIDUAL REPORTS
Reporting forms  CIOMS I form ,[object Object],[object Object]
Reporting forms National reporting forms ,[object Object],[object Object],[object Object]
Minimum information for a valid report ,[object Object],[object Object],[object Object],[object Object]
What needs to be collected? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Healthcare Professionals AGENCY National ADR Database MAH - PhV Qualified Person Individual answer to the reporter (Croatia, New Zealand…) WHO-UMC Database EudraVigilance - Database Marketing Authorisation Holder (through sales representatives) MAH -Central Office  ,[object Object],[object Object],[object Object],[object Object],European Medicines Agency How is it collected?
Collect PSUR Identify Evaluate Take action INDIVIDUAL REPORTS
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],PSUR PERIODIC SAFETY UPDATE REPORT
Collect SIGNAL DETECTION PSURs Identify Evaluate Take action INDIVIDUAL REPORTS
Signal Detection Today:  Large & Complex computerised systems Signal:  new, previously unknown safety information
Collect SIGNAL DETECTION PSURs Identify Evaluate Take action INDIVIDUAL REPORTS CLINICAL EVALUATION REGULATORY ACTION INFORMATION TO HEALTHCARE PROFESSIONALS AND THE PUBLIC
Regulatory actions  on the basis of ADR reports ,[object Object]
Product Information ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory actions  on the basis of ADR reports ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Information to Healthcare Professionals and the Public ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]
 
Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4,  Zagreb tel. 01/ 46 93 830;  fax. 01/ 46 73 275
Pharmacovigilance Unit ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Educational activities ,[object Object],[object Object],[object Object],[object Object],[object Object]
Educational activities
Educational activities - results ,[object Object],[object Object],[object Object],[object Object]
Educational activities - results ,[object Object]
 
Introduction to the Workshop
What is an Adverse Reaction? ,[object Object],[object Object],[object Object],[object Object]
Types of Adverse  Reactions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Types of Adverse  Reactions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Types of Adverse  Reactions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Serious  adverse reaction ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Unexpected  Adverse Reaction ,[object Object]
Causality Assessment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Adverse Drug Reaction!
Definite/certain ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Probable ,[object Object],[object Object],[object Object],[object Object]
Possible ,[object Object],[object Object],[object Object],[object Object]
Causality unclear (unlikely) ,[object Object],[object Object],[object Object],[object Object],[object Object]
WHO causality classification Probable Unlikely Unlikely Possible No data on dechallenge  Possible Possible Dechallenge Probable No Dechallenge i rechallenge Certain Other factors Time relationship
Time for exercise!
Case 1 ,[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case 2 ,[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Mais conteúdo relacionado

Mais procurados (20)

Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Presentation CIOMS VIII
Presentation CIOMS VIIIPresentation CIOMS VIII
Presentation CIOMS VIII
 
Detection and monitoring of ADRs
Detection and monitoring of ADRsDetection and monitoring of ADRs
Detection and monitoring of ADRs
 
History of Pharmacovigilance
History of PharmacovigilanceHistory of Pharmacovigilance
History of Pharmacovigilance
 
Drug safety evaluation in clinical trial
Drug safety evaluation in clinical trialDrug safety evaluation in clinical trial
Drug safety evaluation in clinical trial
 
Pharmacovigilance Basics
Pharmacovigilance BasicsPharmacovigilance Basics
Pharmacovigilance Basics
 
Safety monitoring in clinical trails
Safety monitoring in clinical trailsSafety monitoring in clinical trails
Safety monitoring in clinical trails
 
History and progress of pharmacovigilance
History and progress of pharmacovigilanceHistory and progress of pharmacovigilance
History and progress of pharmacovigilance
 
PSUR
PSURPSUR
PSUR
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’SSEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
 
Spontaneous Reporting System
Spontaneous Reporting SystemSpontaneous Reporting System
Spontaneous Reporting System
 
Aggregate Reporting_Pharmacovigilance_Katalyst HLS
Aggregate Reporting_Pharmacovigilance_Katalyst HLSAggregate Reporting_Pharmacovigilance_Katalyst HLS
Aggregate Reporting_Pharmacovigilance_Katalyst HLS
 
Pharmacovigilance overview
Pharmacovigilance overviewPharmacovigilance overview
Pharmacovigilance overview
 
Adverse drug reactions
Adverse drug reactionsAdverse drug reactions
Adverse drug reactions
 
CIOMS (1).pptx
CIOMS (1).pptxCIOMS (1).pptx
CIOMS (1).pptx
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Ddd talk
Ddd talkDdd talk
Ddd talk
 
GVP module VI
GVP module VIGVP module VI
GVP module VI
 
Investigator's Brochure
Investigator's BrochureInvestigator's Brochure
Investigator's Brochure
 

Destaque

Pharmacovigilance full information
Pharmacovigilance full informationPharmacovigilance full information
Pharmacovigilance full informationRavindra Kumar
 
Pharmacovigilance in real life may 12
Pharmacovigilance in real life   may 12Pharmacovigilance in real life   may 12
Pharmacovigilance in real life may 12Doctors.net.uk
 
Pharmacovigilance ppt
Pharmacovigilance pptPharmacovigilance ppt
Pharmacovigilance pptPrasad Bhat
 
Pharmacovigilance overview shraddha
Pharmacovigilance  overview shraddhaPharmacovigilance  overview shraddha
Pharmacovigilance overview shraddhaDr. Shraddha Bhange
 
What’s new in Pharmacovigilance
What’s new in PharmacovigilanceWhat’s new in Pharmacovigilance
What’s new in PharmacovigilanceMarket iT
 
Pharmacovigilance in Australia
Pharmacovigilance in AustraliaPharmacovigilance in Australia
Pharmacovigilance in AustraliaSaeeda Hasan
 
Medical informatics - Linking diseases, drugs, and adverse reactions
Medical informatics - Linking diseases, drugs, and adverse reactionsMedical informatics - Linking diseases, drugs, and adverse reactions
Medical informatics - Linking diseases, drugs, and adverse reactionsLars Juhl Jensen
 
Pharmacovigilance at Trauma Center, AIIMS
Pharmacovigilance at Trauma Center, AIIMSPharmacovigilance at Trauma Center, AIIMS
Pharmacovigilance at Trauma Center, AIIMSDr.Sharad H. Gajuryal
 
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
 
Pharmacovigilance overview
Pharmacovigilance overviewPharmacovigilance overview
Pharmacovigilance overviewAcri India
 
Webinar pv use case 23 march2016
Webinar pv use case 23 march2016Webinar pv use case 23 march2016
Webinar pv use case 23 march2016Ann-Marie Roche
 
Pharmacovigilance Practice In
Pharmacovigilance Practice InPharmacovigilance Practice In
Pharmacovigilance Practice Inclarityeye
 
Safety reports. addendum to the clinical overview. aco
Safety reports. addendum to the clinical overview. acoSafety reports. addendum to the clinical overview. aco
Safety reports. addendum to the clinical overview. acoAzierta
 
Safety reports rmp risk management plan pharmacovigilance
Safety reports rmp risk management plan pharmacovigilanceSafety reports rmp risk management plan pharmacovigilance
Safety reports rmp risk management plan pharmacovigilanceAzierta
 
Volume 9 A Guidelines On Pharmacovigilance[1]
Volume 9 A Guidelines On Pharmacovigilance[1]Volume 9 A Guidelines On Pharmacovigilance[1]
Volume 9 A Guidelines On Pharmacovigilance[1]siddharthchachad
 

Destaque (20)

Pharmacovigilance full information
Pharmacovigilance full informationPharmacovigilance full information
Pharmacovigilance full information
 
Pharmacovigilance in real life may 12
Pharmacovigilance in real life   may 12Pharmacovigilance in real life   may 12
Pharmacovigilance in real life may 12
 
Pharmacovigilance ppt
Pharmacovigilance pptPharmacovigilance ppt
Pharmacovigilance ppt
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Pharmacovigilance overview shraddha
Pharmacovigilance  overview shraddhaPharmacovigilance  overview shraddha
Pharmacovigilance overview shraddha
 
Vaccine pharmacovigilance _ rajiv ahlawat
Vaccine pharmacovigilance _ rajiv ahlawatVaccine pharmacovigilance _ rajiv ahlawat
Vaccine pharmacovigilance _ rajiv ahlawat
 
What’s new in Pharmacovigilance
What’s new in PharmacovigilanceWhat’s new in Pharmacovigilance
What’s new in Pharmacovigilance
 
Pharmacovigilance in Australia
Pharmacovigilance in AustraliaPharmacovigilance in Australia
Pharmacovigilance in Australia
 
Medical informatics - Linking diseases, drugs, and adverse reactions
Medical informatics - Linking diseases, drugs, and adverse reactionsMedical informatics - Linking diseases, drugs, and adverse reactions
Medical informatics - Linking diseases, drugs, and adverse reactions
 
Pharmacovigilance at Trauma Center, AIIMS
Pharmacovigilance at Trauma Center, AIIMSPharmacovigilance at Trauma Center, AIIMS
Pharmacovigilance at Trauma Center, AIIMS
 
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016
 
Pharmacovigilance overview
Pharmacovigilance overviewPharmacovigilance overview
Pharmacovigilance overview
 
Adverse drug reactions
Adverse drug reactionsAdverse drug reactions
Adverse drug reactions
 
Webinar pv use case 23 march2016
Webinar pv use case 23 march2016Webinar pv use case 23 march2016
Webinar pv use case 23 march2016
 
Pharmacovigilance Practice In
Pharmacovigilance Practice InPharmacovigilance Practice In
Pharmacovigilance Practice In
 
Pharmacovigilance for ASU Drugs
Pharmacovigilance for ASU DrugsPharmacovigilance for ASU Drugs
Pharmacovigilance for ASU Drugs
 
Safety reports. addendum to the clinical overview. aco
Safety reports. addendum to the clinical overview. acoSafety reports. addendum to the clinical overview. aco
Safety reports. addendum to the clinical overview. aco
 
Safety reports rmp risk management plan pharmacovigilance
Safety reports rmp risk management plan pharmacovigilanceSafety reports rmp risk management plan pharmacovigilance
Safety reports rmp risk management plan pharmacovigilance
 
Volume 9 A Guidelines On Pharmacovigilance[1]
Volume 9 A Guidelines On Pharmacovigilance[1]Volume 9 A Guidelines On Pharmacovigilance[1]
Volume 9 A Guidelines On Pharmacovigilance[1]
 
Analgesicos
AnalgesicosAnalgesicos
Analgesicos
 

Semelhante a Pharmacovigilance Workshop

pharmacovigilance pdf (1)
pharmacovigilance pdf (1)pharmacovigilance pdf (1)
pharmacovigilance pdf (1)Prasad Bhat
 
Pharmacovigilance pdf (1)
Pharmacovigilance pdf (1)Pharmacovigilance pdf (1)
Pharmacovigilance pdf (1)Prasad Bhat
 
PHARMACOVIGILANCE - A Worldwide masterkey for Drug Monitoring
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringPHARMACOVIGILANCE - A Worldwide masterkey for Drug Monitoring
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringVenugopal N
 
Pharmacovigilance by bishnu koirala
Pharmacovigilance by bishnu koiralaPharmacovigilance by bishnu koirala
Pharmacovigilance by bishnu koiralaBishnu Koirala
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
PharmacovigilancePrasathP13
 
Understanding pharmacovigilance
Understanding pharmacovigilanceUnderstanding pharmacovigilance
Understanding pharmacovigilancefinenessinstitute
 
importance of pharmcovigilance
importance of pharmcovigilanceimportance of pharmcovigilance
importance of pharmcovigilancesiddemsetty nikhil
 
post marketing surveillance OF DRUG PRODUCTS
post marketing surveillance OF DRUG PRODUCTSpost marketing surveillance OF DRUG PRODUCTS
post marketing surveillance OF DRUG PRODUCTSPrakashGoudanavar
 
Drug Safety Regulations In The Us And Eu
Drug Safety Regulations In The Us And EuDrug Safety Regulations In The Us And Eu
Drug Safety Regulations In The Us And EuAngelinabarfield
 
Pharmacovigilance Overview
Pharmacovigilance OverviewPharmacovigilance Overview
Pharmacovigilance OverviewSivasankaranV
 
Pharmacovigilance AN
Pharmacovigilance ANPharmacovigilance AN
Pharmacovigilance ANAhmed Nouri
 
Introduction on Pharmacovigilance.pptx
Introduction on Pharmacovigilance.pptxIntroduction on Pharmacovigilance.pptx
Introduction on Pharmacovigilance.pptxvedanshu malviya
 

Semelhante a Pharmacovigilance Workshop (20)

pharmacovigilance pdf (1)
pharmacovigilance pdf (1)pharmacovigilance pdf (1)
pharmacovigilance pdf (1)
 
Pharmacovigilance pdf (1)
Pharmacovigilance pdf (1)Pharmacovigilance pdf (1)
Pharmacovigilance pdf (1)
 
PHARMACOVIGILANCE - A Worldwide masterkey for Drug Monitoring
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringPHARMACOVIGILANCE - A Worldwide masterkey for Drug Monitoring
PHARMACOVIGILANCE - A Worldwide masterkey for Drug Monitoring
 
Pharmacovigilance: A review
Pharmacovigilance: A reviewPharmacovigilance: A review
Pharmacovigilance: A review
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Pharmacovigilance by bishnu koirala
Pharmacovigilance by bishnu koiralaPharmacovigilance by bishnu koirala
Pharmacovigilance by bishnu koirala
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Understanding pharmacovigilance
Understanding pharmacovigilanceUnderstanding pharmacovigilance
Understanding pharmacovigilance
 
20. Dr. Shanthi Pal - World Health Organization
20. Dr. Shanthi Pal - World Health Organization 20. Dr. Shanthi Pal - World Health Organization
20. Dr. Shanthi Pal - World Health Organization
 
Dcgi adverse event
Dcgi adverse eventDcgi adverse event
Dcgi adverse event
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
importance of pharmcovigilance
importance of pharmcovigilanceimportance of pharmcovigilance
importance of pharmcovigilance
 
post marketing surveillance OF DRUG PRODUCTS
post marketing surveillance OF DRUG PRODUCTSpost marketing surveillance OF DRUG PRODUCTS
post marketing surveillance OF DRUG PRODUCTS
 
Drug Safety Regulations In The Us And Eu
Drug Safety Regulations In The Us And EuDrug Safety Regulations In The Us And Eu
Drug Safety Regulations In The Us And Eu
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Pharmacovigilance Overview
Pharmacovigilance OverviewPharmacovigilance Overview
Pharmacovigilance Overview
 
Pharmacovigilance
Pharmacovigilance Pharmacovigilance
Pharmacovigilance
 
Pharmacovigilance AN
Pharmacovigilance ANPharmacovigilance AN
Pharmacovigilance AN
 
pharmacovigilance study
pharmacovigilance studypharmacovigilance study
pharmacovigilance study
 
Introduction on Pharmacovigilance.pptx
Introduction on Pharmacovigilance.pptxIntroduction on Pharmacovigilance.pptx
Introduction on Pharmacovigilance.pptx
 

Mais de inemet

EUFEPS and European Initiatives in Pharmaceutical Sciences
EUFEPS and European Initiatives in Pharmaceutical SciencesEUFEPS and European Initiatives in Pharmaceutical Sciences
EUFEPS and European Initiatives in Pharmaceutical Sciencesinemet
 
Legal requirements for generics and abridged products and bioequivalence
Legal requirements for generics and abridged products and bioequivalenceLegal requirements for generics and abridged products and bioequivalence
Legal requirements for generics and abridged products and bioequivalenceinemet
 
Significance of BA/BE studies in drug research and evaluation of different as...
Significance of BA/BE studies in drug research and evaluation of different as...Significance of BA/BE studies in drug research and evaluation of different as...
Significance of BA/BE studies in drug research and evaluation of different as...inemet
 
The role of dissolution in the demonstration of bioequivalence
The role of dissolution in the demonstration of bioequivalenceThe role of dissolution in the demonstration of bioequivalence
The role of dissolution in the demonstration of bioequivalenceinemet
 
Future trends and perspectives in modern pharmaceutical biotechnology
Future trends and perspectives in modern pharmaceutical biotechnologyFuture trends and perspectives in modern pharmaceutical biotechnology
Future trends and perspectives in modern pharmaceutical biotechnologyinemet
 
Focussing on cytotoxic treatment alone is not enough
Focussing on cytotoxic treatment alone is not enoughFocussing on cytotoxic treatment alone is not enough
Focussing on cytotoxic treatment alone is not enoughinemet
 
Bioavailability and bioequivalence – problems and pitfalls
Bioavailability and bioequivalence – problems and pitfallsBioavailability and bioequivalence – problems and pitfalls
Bioavailability and bioequivalence – problems and pitfallsinemet
 
Quo Vadis EU Pharmacy?
Quo Vadis EU Pharmacy?Quo Vadis EU Pharmacy?
Quo Vadis EU Pharmacy?inemet
 
Education - Do we have a choice?
Education - Do we have a choice?Education - Do we have a choice?
Education - Do we have a choice?inemet
 
The truth between the lines – Community pharmacists in improving the health o...
The truth between the lines – Community pharmacists in improving the health o...The truth between the lines – Community pharmacists in improving the health o...
The truth between the lines – Community pharmacists in improving the health o...inemet
 
BY HELPING PEOPLE MY DREAM IS BECOMING TRUE
BY HELPING PEOPLE MY DREAM IS BECOMING TRUEBY HELPING PEOPLE MY DREAM IS BECOMING TRUE
BY HELPING PEOPLE MY DREAM IS BECOMING TRUEinemet
 
POSTGENETICS MEDICINE
POSTGENETICS MEDICINEPOSTGENETICS MEDICINE
POSTGENETICS MEDICINEinemet
 
SHARING VISION – TOWARDS BIOMEDICINE PARTNERS
SHARING VISION – TOWARDS BIOMEDICINE PARTNERSSHARING VISION – TOWARDS BIOMEDICINE PARTNERS
SHARING VISION – TOWARDS BIOMEDICINE PARTNERSinemet
 
Sightseeing Pharmacy practice - The way forward
Sightseeing Pharmacy practice - The way forwardSightseeing Pharmacy practice - The way forward
Sightseeing Pharmacy practice - The way forwardinemet
 
EU telematics in the regulation of pharmaceuticals
EU telematics in the regulation of pharmaceuticalsEU telematics in the regulation of pharmaceuticals
EU telematics in the regulation of pharmaceuticalsinemet
 
Generics and Biogenerics
Generics and BiogenericsGenerics and Biogenerics
Generics and Biogenericsinemet
 
ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...
ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...
ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...inemet
 
Making knowledge matter: The Skills Inventory and the Competency Maps
Making knowledge matter: The Skills Inventory and the Competency MapsMaking knowledge matter: The Skills Inventory and the Competency Maps
Making knowledge matter: The Skills Inventory and the Competency Mapsinemet
 
Trigger Point – Self-medication: Patients in white coats
Trigger Point – Self-medication: Patients in white coats Trigger Point – Self-medication: Patients in white coats
Trigger Point – Self-medication: Patients in white coats inemet
 
Pharmacy in croatia - A short overview
Pharmacy in croatia - A short overviewPharmacy in croatia - A short overview
Pharmacy in croatia - A short overviewinemet
 

Mais de inemet (20)

EUFEPS and European Initiatives in Pharmaceutical Sciences
EUFEPS and European Initiatives in Pharmaceutical SciencesEUFEPS and European Initiatives in Pharmaceutical Sciences
EUFEPS and European Initiatives in Pharmaceutical Sciences
 
Legal requirements for generics and abridged products and bioequivalence
Legal requirements for generics and abridged products and bioequivalenceLegal requirements for generics and abridged products and bioequivalence
Legal requirements for generics and abridged products and bioequivalence
 
Significance of BA/BE studies in drug research and evaluation of different as...
Significance of BA/BE studies in drug research and evaluation of different as...Significance of BA/BE studies in drug research and evaluation of different as...
Significance of BA/BE studies in drug research and evaluation of different as...
 
The role of dissolution in the demonstration of bioequivalence
The role of dissolution in the demonstration of bioequivalenceThe role of dissolution in the demonstration of bioequivalence
The role of dissolution in the demonstration of bioequivalence
 
Future trends and perspectives in modern pharmaceutical biotechnology
Future trends and perspectives in modern pharmaceutical biotechnologyFuture trends and perspectives in modern pharmaceutical biotechnology
Future trends and perspectives in modern pharmaceutical biotechnology
 
Focussing on cytotoxic treatment alone is not enough
Focussing on cytotoxic treatment alone is not enoughFocussing on cytotoxic treatment alone is not enough
Focussing on cytotoxic treatment alone is not enough
 
Bioavailability and bioequivalence – problems and pitfalls
Bioavailability and bioequivalence – problems and pitfallsBioavailability and bioequivalence – problems and pitfalls
Bioavailability and bioequivalence – problems and pitfalls
 
Quo Vadis EU Pharmacy?
Quo Vadis EU Pharmacy?Quo Vadis EU Pharmacy?
Quo Vadis EU Pharmacy?
 
Education - Do we have a choice?
Education - Do we have a choice?Education - Do we have a choice?
Education - Do we have a choice?
 
The truth between the lines – Community pharmacists in improving the health o...
The truth between the lines – Community pharmacists in improving the health o...The truth between the lines – Community pharmacists in improving the health o...
The truth between the lines – Community pharmacists in improving the health o...
 
BY HELPING PEOPLE MY DREAM IS BECOMING TRUE
BY HELPING PEOPLE MY DREAM IS BECOMING TRUEBY HELPING PEOPLE MY DREAM IS BECOMING TRUE
BY HELPING PEOPLE MY DREAM IS BECOMING TRUE
 
POSTGENETICS MEDICINE
POSTGENETICS MEDICINEPOSTGENETICS MEDICINE
POSTGENETICS MEDICINE
 
SHARING VISION – TOWARDS BIOMEDICINE PARTNERS
SHARING VISION – TOWARDS BIOMEDICINE PARTNERSSHARING VISION – TOWARDS BIOMEDICINE PARTNERS
SHARING VISION – TOWARDS BIOMEDICINE PARTNERS
 
Sightseeing Pharmacy practice - The way forward
Sightseeing Pharmacy practice - The way forwardSightseeing Pharmacy practice - The way forward
Sightseeing Pharmacy practice - The way forward
 
EU telematics in the regulation of pharmaceuticals
EU telematics in the regulation of pharmaceuticalsEU telematics in the regulation of pharmaceuticals
EU telematics in the regulation of pharmaceuticals
 
Generics and Biogenerics
Generics and BiogenericsGenerics and Biogenerics
Generics and Biogenerics
 
ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...
ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...
ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...
 
Making knowledge matter: The Skills Inventory and the Competency Maps
Making knowledge matter: The Skills Inventory and the Competency MapsMaking knowledge matter: The Skills Inventory and the Competency Maps
Making knowledge matter: The Skills Inventory and the Competency Maps
 
Trigger Point – Self-medication: Patients in white coats
Trigger Point – Self-medication: Patients in white coats Trigger Point – Self-medication: Patients in white coats
Trigger Point – Self-medication: Patients in white coats
 
Pharmacy in croatia - A short overview
Pharmacy in croatia - A short overviewPharmacy in croatia - A short overview
Pharmacy in croatia - A short overview
 

Último

Borderless Access - Global B2B Panel book-unlock 2024
Borderless Access - Global B2B Panel book-unlock 2024Borderless Access - Global B2B Panel book-unlock 2024
Borderless Access - Global B2B Panel book-unlock 2024Borderless Access
 
Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024Borderless Access
 
MoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor PresentationMoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor Presentationbaron83
 
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdf
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdfGraham and Doddsville - Issue 1 - Winter 2006 (1).pdf
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdfAnhNguyen97152
 
Slicing Work on Business Agility Meetup Berlin
Slicing Work on Business Agility Meetup BerlinSlicing Work on Business Agility Meetup Berlin
Slicing Work on Business Agility Meetup BerlinAnton Skornyakov
 
Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdf
Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdfChicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdf
Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdfSourav Sikder
 
The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003
The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003
The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003believeminhh
 
Project Brief & Information Architecture Report
Project Brief & Information Architecture ReportProject Brief & Information Architecture Report
Project Brief & Information Architecture Reportamberjiles31
 
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdfTalent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdfCharles Cotter, PhD
 
Q2 2024 APCO Geopolitical Radar - The Global Operating Environment for Business
Q2 2024 APCO Geopolitical Radar - The Global Operating Environment for BusinessQ2 2024 APCO Geopolitical Radar - The Global Operating Environment for Business
Q2 2024 APCO Geopolitical Radar - The Global Operating Environment for BusinessAPCO
 
Plano de marketing- inglês em formato ppt
Plano de marketing- inglês  em formato pptPlano de marketing- inglês  em formato ppt
Plano de marketing- inglês em formato pptElizangelaSoaresdaCo
 
Tata Kelola Bisnis perushaan yang bergerak
Tata Kelola Bisnis perushaan yang bergerakTata Kelola Bisnis perushaan yang bergerak
Tata Kelola Bisnis perushaan yang bergerakEditores1
 
Fabric RFID Wristbands in Ireland for Events and Festivals
Fabric RFID Wristbands in Ireland for Events and FestivalsFabric RFID Wristbands in Ireland for Events and Festivals
Fabric RFID Wristbands in Ireland for Events and FestivalsWristbands Ireland
 
Building Your Personal Brand on LinkedIn - Expert Planet- 2024
 Building Your Personal Brand on LinkedIn - Expert Planet-  2024 Building Your Personal Brand on LinkedIn - Expert Planet-  2024
Building Your Personal Brand on LinkedIn - Expert Planet- 2024Stephan Koning
 
Live-Streaming in the Music Industry Webinar
Live-Streaming in the Music Industry WebinarLive-Streaming in the Music Industry Webinar
Live-Streaming in the Music Industry WebinarNathanielSchmuck
 
NASA CoCEI Scaling Strategy - November 2023
NASA CoCEI Scaling Strategy - November 2023NASA CoCEI Scaling Strategy - November 2023
NASA CoCEI Scaling Strategy - November 2023Steve Rader
 
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)tazeenaila12
 
Intellectual Property Licensing Examples
Intellectual Property Licensing ExamplesIntellectual Property Licensing Examples
Intellectual Property Licensing Examplesamberjiles31
 
7movierulz.uk
7movierulz.uk7movierulz.uk
7movierulz.ukaroemirsr
 

Último (20)

Borderless Access - Global B2B Panel book-unlock 2024
Borderless Access - Global B2B Panel book-unlock 2024Borderless Access - Global B2B Panel book-unlock 2024
Borderless Access - Global B2B Panel book-unlock 2024
 
Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024
 
MoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor PresentationMoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor Presentation
 
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdf
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdfGraham and Doddsville - Issue 1 - Winter 2006 (1).pdf
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdf
 
Slicing Work on Business Agility Meetup Berlin
Slicing Work on Business Agility Meetup BerlinSlicing Work on Business Agility Meetup Berlin
Slicing Work on Business Agility Meetup Berlin
 
Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdf
Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdfChicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdf
Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdf
 
The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003
The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003
The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003
 
Project Brief & Information Architecture Report
Project Brief & Information Architecture ReportProject Brief & Information Architecture Report
Project Brief & Information Architecture Report
 
WAM Corporate Presentation Mar 25 2024.pdf
WAM Corporate Presentation Mar 25 2024.pdfWAM Corporate Presentation Mar 25 2024.pdf
WAM Corporate Presentation Mar 25 2024.pdf
 
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdfTalent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
 
Q2 2024 APCO Geopolitical Radar - The Global Operating Environment for Business
Q2 2024 APCO Geopolitical Radar - The Global Operating Environment for BusinessQ2 2024 APCO Geopolitical Radar - The Global Operating Environment for Business
Q2 2024 APCO Geopolitical Radar - The Global Operating Environment for Business
 
Plano de marketing- inglês em formato ppt
Plano de marketing- inglês  em formato pptPlano de marketing- inglês  em formato ppt
Plano de marketing- inglês em formato ppt
 
Tata Kelola Bisnis perushaan yang bergerak
Tata Kelola Bisnis perushaan yang bergerakTata Kelola Bisnis perushaan yang bergerak
Tata Kelola Bisnis perushaan yang bergerak
 
Fabric RFID Wristbands in Ireland for Events and Festivals
Fabric RFID Wristbands in Ireland for Events and FestivalsFabric RFID Wristbands in Ireland for Events and Festivals
Fabric RFID Wristbands in Ireland for Events and Festivals
 
Building Your Personal Brand on LinkedIn - Expert Planet- 2024
 Building Your Personal Brand on LinkedIn - Expert Planet-  2024 Building Your Personal Brand on LinkedIn - Expert Planet-  2024
Building Your Personal Brand on LinkedIn - Expert Planet- 2024
 
Live-Streaming in the Music Industry Webinar
Live-Streaming in the Music Industry WebinarLive-Streaming in the Music Industry Webinar
Live-Streaming in the Music Industry Webinar
 
NASA CoCEI Scaling Strategy - November 2023
NASA CoCEI Scaling Strategy - November 2023NASA CoCEI Scaling Strategy - November 2023
NASA CoCEI Scaling Strategy - November 2023
 
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
 
Intellectual Property Licensing Examples
Intellectual Property Licensing ExamplesIntellectual Property Licensing Examples
Intellectual Property Licensing Examples
 
7movierulz.uk
7movierulz.uk7movierulz.uk
7movierulz.uk
 

Pharmacovigilance Workshop

  • 2.
  • 3.
  • 4.
  • 5.
  • 6. From test tube to the market – PRECLINICAL RESEARCH SYNTHESIS CANDIDATES SAFETY, TOLERABILITY & PHARMACOKINETICS Toxicity testing , reproductive toxicology, carcinogenicity, genotoxicity, toxicokinetics DRUG SCREENING activity & selectivity = Pharmacological profile
  • 7. From test tube to the market – CLINICAL RESEARCH PHASE I PHASE III PHASE II “ First-in-Man Trial” Pharmacokinetics Metabolism Pharmacology Safety (early effectiveness) 20-80 HEALTHY VOLUNTEERS Preliminary data on efficacy for a particular indication(s) Short-term Adverse Drug Reactions Dose range SEVERAL HUNDRED PATIENTS WITH DISEASES OR CONDITION SEVERAL HUNDRED TO THOUSAND PATIENTS Efficacy and safety for overall benefit-risk assessment Product information APPROVAL
  • 8. ? Limitations of Clinical Study Data ? Variable (compliance?) Fixed Dose Flexible; less information Rigorous; more information Conditions Usually present Avoided Concomitant medication and illness All Pregnant, children, elderly excluded Population Years Weeks Duration Thousands to millions Hundreds (rarely thousands) Number of patients Clinical Practice Clinical trials
  • 9. Drug Safety Information Formulation (STRUCTURE ACTIVITY RELATIONSHIP) Preclinical studies (TOXICOLOGY, PHARMACOLOGY, PHARMACOKINETICS) Clinical studies (IDENTIFICATION OF ADRs, CHARACTERISATION, CAUSALITY, FREQUENCY, MANAGING) Pre marketing RARE ADRs? CHRONIC USE? DELAYED ADRs? INTERACTIONS? CHILDREN/ELDERLY?
  • 10. From test tube to the market – CLINICAL RESEARCH PHASE I PHASE III PHASE II “ First-in-Man Trial” Pharmacokinetics Metabolism Pharmacology Safety (early effectiveness) 20-80 HEALTHY VOLUNTEERS Preliminary data on efficacy for a particular indication(s) Short-term Adverse Drug Reactions Dose range SEVERAL HUNDRED PATIENTS WITH DISEASES OR CONDITION SEVERAL HUNDRED TO THOUSAND PATIENTS Efficacy and safety for overall benefit-risk assessment Product information APPROVAL POSTMARKETING SURVEILLANCE
  • 11.
  • 12.
  • 13. Withdrawals from the market as a result of spontaneous reporting 1998 1997 Serious hepatotoxic effect bromfenac 1998 1985 Fatal cardiac arrythmias terfenadine 1992 1992 Haemolytic anemia temafloxacin 1991 1987 Excessive mortality encainide 1982 1982 Onycholysis, renal, liver, bone marrow toxicity benoxaprofen 1975 1970 Blindness practolol Year of withdrawal Year of approval Reason for withdrawal INN
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19. The Concept of Pharmacovigilance System
  • 20. Pharmacovigilance – concerned parties Competent Authorities (National Agencies, European Medicines Agency) Healthcare Professionals: Voluntary reporting or Mandatory reporting WHO Pharmaceutical Industry (Marketing Authorisation Holder & Sponsor of Clinical Trials) Patients: Complain or Complain & Report
  • 21. Collect Identify Evaluate Take action INDIVIDUAL REPORTS
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27. Collect PSUR Identify Evaluate Take action INDIVIDUAL REPORTS
  • 28.
  • 29. Collect SIGNAL DETECTION PSURs Identify Evaluate Take action INDIVIDUAL REPORTS
  • 30. Signal Detection Today: Large & Complex computerised systems Signal: new, previously unknown safety information
  • 31. Collect SIGNAL DETECTION PSURs Identify Evaluate Take action INDIVIDUAL REPORTS CLINICAL EVALUATION REGULATORY ACTION INFORMATION TO HEALTHCARE PROFESSIONALS AND THE PUBLIC
  • 32.
  • 33.
  • 34.
  • 35.
  • 36.
  • 37.
  • 38.  
  • 39. Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, Zagreb tel. 01/ 46 93 830; fax. 01/ 46 73 275
  • 40.
  • 41.
  • 43.
  • 44.
  • 45.  
  • 47.
  • 48.
  • 49.
  • 50.
  • 51.
  • 52.
  • 53.
  • 54.
  • 55.
  • 56.
  • 57.
  • 58. WHO causality classification Probable Unlikely Unlikely Possible No data on dechallenge Possible Possible Dechallenge Probable No Dechallenge i rechallenge Certain Other factors Time relationship
  • 60.
  • 61.
  • 62.
  • 63.
  • 64.
  • 65.