prev
next
out of 18

Post Marketing Surveillance Ppt

  • Upload
    nashmia

  • View
    236

  • Download
    0

Embed Size (px)

Citation preview

  • 8/9/2019 Post Marketing Surveillance Ppt

    1/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    2/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    3/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    4/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    5/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    6/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    7/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    8/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    9/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    10/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    11/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    12/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    13/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    14/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    15/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    16/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    17/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    18/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    19/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    20/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    21/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    22/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    23/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    24/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    25/46

    http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htmhttp://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm

  • 8/9/2019 Post Marketing Surveillance Ppt

    26/46

    http://www.fda.gov/medwatch/)http://www.fda.gov/medwatch/)http://www.fda.gov/medwatch/)

  • 8/9/2019 Post Marketing Surveillance Ppt

    27/46

    https://www.safetyreporting.hhs.gov/fpsr/WorkflowLoginIO.aspx?metinstance=F3364E33E164EBA7A4FE95252FEC184FCC304D42https://www.safetyreporting.hhs.gov/fpsr/WorkflowLoginIO.aspx?metinstance=F3364E33E164EBA7A4FE95252FEC184FCC304D42

  • 8/9/2019 Post Marketing Surveillance Ppt

    28/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    29/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    30/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    31/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    32/46

    http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/ucm2007229.htm

  • 8/9/2019 Post Marketing Surveillance Ppt

    33/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    34/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    35/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    36/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    37/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    38/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    39/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    40/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    41/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    42/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    43/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    44/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    45/46

  • 8/9/2019 Post Marketing Surveillance Ppt

    46/46

    http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffechttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffechttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffechttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffechttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffechttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffechttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffechttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmhttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/defahttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/defahttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/defahttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/defahttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/defahttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/defahttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/defahttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/defahttp://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xmlhttp://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xmlhttp://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xmlhttp://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xmlhttp://www.fda.gov/Safety/MedWatch/ucm287881.htmhttp://www.fda.gov/Safety/MedWatch/ucm287881.htmhttp://www.fda.gov/Safety/MedWatch/ucm287881.htmhttp://www.fda.gov/Safety/MedWatch/ucm287881.htmhttp://www.fda.gov/Safety/MedWatch/ucm287881.htmhttp://www.fda.gov/Safety/MedWatch/ucm287881.htmhttp://www.fda.gov/Safety/MedWatch/ucm287881.htmhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htmhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htmhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htmhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htmhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htmhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htmhttp://www.fda.gov/Safety/MedWatch/default.htmhttp://www.fda.gov/Safety/MedWatch/default.htmhttp://www.fda.gov/Safety/MedWatch/default.htmhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdfhttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfmhttp://www.fda.gov/Drugs/DrugSafety/ucm199082.htmhttp://www.fda.gov/Drugs/DrugSafety/ucm199082.htmhttp://www.fda.gov/Drugs/DrugSafety/ucm199082.htmhttp://www.fda.gov/Drugs/DrugSafety/ucm199082.htmhttp://www.fda.gov/Drugs/DrugSafety/ucm199082.htmhttp://www.fda.gov/Drugs/DrugSafety/ucm199082.htm

Effective post-market surveillance - BSI Group post-market surveillance Understanding and conducting vigilance and post-market clinical follow-up Ibim Tariah, Technical Expert, BSI

Effective post-market surveillance - BSI Group post-market surveillance Understanding and conducting vigilance and post-market clinical follow-up Ibim Tariah, Technical Expert, BSI

Documents
to Post-Marketing Surveillance - Fujitsu€¦ · Feasibility Study on Applying CDISC SDTM to Post-Marketing Surveillance ... • Applying SDTM to Post-Marketing Surveillance What

to Post-Marketing Surveillance - Fujitsu€¦ · Feasibility Study on Applying CDISC SDTM to Post-Marketing Surveillance ... • Applying SDTM to Post-Marketing Surveillance What

Documents
Post -Marketing Drug Safety Surveillance

Post -Marketing Drug Safety Surveillance

Healthcare
FDA Post-Marketing Surveillance

FDA Post-Marketing Surveillance

Documents
POST MARKETING SURVEILLANCE (PMS) REPORT FOR …

POST MARKETING SURVEILLANCE (PMS) REPORT FOR …

Documents
POST-MARKET QUALITY SURVEILLANCE PROJECT MATERNAL

POST-MARKET QUALITY SURVEILLANCE PROJECT MATERNAL

Documents
Surveillance médicale post-exposition et post ... · Surveillance médicale post-exposition et post-professionnelle après exposition à l’amiante JC Pairon Institut Santé -Travail

Surveillance médicale post-exposition et post ... · Surveillance médicale post-exposition et post-professionnelle après exposition à l’amiante JC Pairon Institut Santé -Travail

Documents
Drug safety and Post-marketing surveillance

Drug safety and Post-marketing surveillance

Health & Medicine
Post-authorization Surveillance of Medical Products during

Post-authorization Surveillance of Medical Products during

Documents
Chapter 4. Post-marketing Surveillance of Drugs

Chapter 4. Post-marketing Surveillance of Drugs

Documents
POST-MARKETING SURVEILLANCE: ONE DIVISION DIRECTOR’S VIEW

POST-MARKETING SURVEILLANCE: ONE DIVISION DIRECTOR’S VIEW

Documents
Global Post market Surveillance - cbinet.com Post Market Surveillance 3. Post market Clinical Follow-up 4 Comprehensive set of Activities: Passive (Reactive) PMS; • Always required

Global Post market Surveillance - cbinet.com Post Market Surveillance 3. Post market Clinical Follow-up 4 Comprehensive set of Activities: Passive (Reactive) PMS; • Always required

Documents
Post Market Surveillance (PMS) - Erwartungen Die … · ... Clinical evaluation and clinical ... Post-market clinical follow-up ... POST-MARKET SURVEILLANCE PMS-Bericht PMS-Report

Post Market Surveillance (PMS) - Erwartungen Die … · ... Clinical evaluation and clinical ... Post-market clinical follow-up ... POST-MARKET SURVEILLANCE PMS-Bericht PMS-Report

Documents
Surveillance Post-Marketing Part 1 Surveillance Studies...Pre-Marketing Post-marketing Period Safety Data After market launch, the post-marketing surveillance season officially opens,

Surveillance Post-Marketing Part 1 Surveillance Studies...Pre-Marketing Post-marketing Period Safety Data After market launch, the post-marketing surveillance season officially opens,

Documents
Post-marketing Drug Safety Surveillance: Pharmacovigilance

Post-marketing Drug Safety Surveillance: Pharmacovigilance

Documents
Post-Approval & Surveillance Inspection Programs for ... · Post-Approval Inspections ... (211.192) Micro controls for ... Post-Approval & Surveillance Inspection Programs for Pharmaceutical

Post-Approval & Surveillance Inspection Programs for ... · Post-Approval Inspections ... (211.192) Micro controls for ... Post-Approval & Surveillance Inspection Programs for Pharmaceutical

Documents
LA SALLE DE SURVEILLANCE POST- INTERVENTIONNELLE

LA SALLE DE SURVEILLANCE POST- INTERVENTIONNELLE

Documents
WP Post Market Surveillance

WP Post Market Surveillance

Documents
Post-marketing surveillance of chemicals: organisations

Post-marketing surveillance of chemicals: organisations

Documents
Chirurgie bariatrique: surveillance post-opératoire immédiate

Chirurgie bariatrique: surveillance post-opératoire immédiate

Documents
Post-Market Surveillance - Vigilance

Post-Market Surveillance - Vigilance

Documents
POST-MARKET SURVEILLANCE OF PHARMACEUTICALS Report …

POST-MARKET SURVEILLANCE OF PHARMACEUTICALS Report …

Documents
POST MARKETING SURVEILLANCE OF ACTIVE …

POST MARKETING SURVEILLANCE OF ACTIVE …

Documents
Synthèse SURVEILLANCE POST- THÉRAPEUTIQUE …...RECOMMANDATIONS PROFESSIONNELLES SYNTHÈSE CAT POST THÉRAPEUTIQUE DES LÉSIONS PRÉCANCEREUSES DU COL DE L’UTÉRUS 4 SURVEILLANCE

Synthèse SURVEILLANCE POST- THÉRAPEUTIQUE …...RECOMMANDATIONS PROFESSIONNELLES SYNTHÈSE CAT POST THÉRAPEUTIQUE DES LÉSIONS PRÉCANCEREUSES DU COL DE L’UTÉRUS 4 SURVEILLANCE

Documents
FDA Post-Marketing Drug Safety Surveillance Post-Marketing Drug Safety Surveillance LT Ofir Noah Nevo, PharmD, BCPP . Division of Pharmacovigilance . Office of Surveillance and Epidemiology

FDA Post-Marketing Drug Safety Surveillance Post-Marketing Drug Safety Surveillance LT Ofir Noah Nevo, PharmD, BCPP . Division of Pharmacovigilance . Office of Surveillance and Epidemiology

Documents
POST-MARKET SURVEILLANCE OF IN VITRO DIAGNOSTICS

POST-MARKET SURVEILLANCE OF IN VITRO DIAGNOSTICS

Documents
Arzerra from approval to post marketing surveillance

Arzerra from approval to post marketing surveillance

Health & Medicine
COMPARISON OF POST-MARKETING SURVEILLANCE …

COMPARISON OF POST-MARKETING SURVEILLANCE …

Documents
Post-MDA surveillance ( including xeno -monitoring)

Post-MDA surveillance ( including xeno -monitoring)

Documents
Surveillance des médicaments vétérinaires en post-AMM

Surveillance des médicaments vétérinaires en post-AMM

Documents