SlideShare ist ein Scribd-Unternehmen logo

Medical Devices Postmarket Surveillance 14 jul13

•
•
Annet Visscher
Annet Visscher
BildungBusinessGesundheit & Medizin
1 von 13
Downloaden Sie, um offline zu lesen
Annet Muetstege Postmarket Surveillance made simpel| Westervoort, 06 July 2013
6 Jul 2013 ACS PMS 2 Reportable Adverse Event? • Serious? • Device related? • Unanticipated?
6 Jul 2013 ACS PMS 3 Medical Devices: a diverse sector
6 Jul 2013 ACS PMS 4 Medical Device Regulation Proposal - Postmarket Surveillance ″ Proportionate to the risk class and the type of device, manufacturers … shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market … and to apply any necessary corrective action, hereinafter referred to as ‘post-market surveillance plan’. • “Post-market clinical follow-up, … a continuous process to update the clinical evaluation referred to in Article 49 and Part A of this Annex and shall be part of the manufacturer's post-market surveillance plan… the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which is authorised to bear the CE marking, within its intended purpose … with the aim of confirming the safety and performance throughout …”
6 Jul 2013 ACS PMS 5 Medical Device Regulation Proposal - Postmarket Clinical Follow-up ″ … PMCF shall be performed pursuant to a documented method laid down in a PMCF plan … ″ specify general methods and procedures, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data … ″ The notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan.”
6 Jul 2013 ACS PMS 6 PMCF - Vigilance ″ … European system for the notification and evaluation of incidents and field safety corrective actions … • Advantage ►Existing company system ►Low additional cost • Challenges ►Reactive ►Issues late in the game (1) MEDDEV 2.12-1 rev 8
6 Jul 2013 ACS PMS 7 PMCF - Literature review ″ The process of reading, analyzing, evaluating, and summarizing scholarly materials about a specific topic.” • Options ►Review relevant sources at regular intervals, e.g. PubMed ►Conferences ►Journal alerting Services • Advantage ►Relatively cheap ►Access to data world wide • Challenges ►Reactive ►Data typically limited and heterogeneous
6 Jul 2013 ACS PMS 8 PMCF - Studies • Options ►Non-interventional – registries ″ A collection of clinical data where all subjects receive the standard hospital treatment and have a parameter of interest in common ►Interventional – RCT ″ Clinical study where participants receive treatment's or test's different from standard practice because of study participation. Such treatment may concern randomization.
6 Jul 2013 ACS PMS 9 PMCF – Registry • Options – several ►Paper/ EDC forms ►Single/ multi center ►… • Advantages ►Value for money ►Low site threshold ►… • Challenges ►No efficacy/ added value data
6 Jul 2013 ACS PMS 10 PMCF – Interventional Study • Options ►Small scale single arm ►RCT • Advantages ►Efficacy and/ or added value ►RCT is gold standard • Challenges ►Not daily practice ►Huge investment ►Blinding
6 Jul 2013 ACS PMS 11 Postmarket Surveillance - Conclusion • PMS under new MDR ►More stringent, and controlled • Various options ►Standard company processes ►Literature review ►Registries ►Randomised Controlled Studies ►…
6 Jul 2013 ACS PMS 12 Questions? Applied Clinical Services BV www.appliedclinicalservices.com info@appliedclinicalservices.com +31 26 848 5281
6 Jul 2013 ACS PMS 13 Applied Clinical Services BV • Co-founded by Annet Muetstege • Mission ► To contribute to better patient outcomes in health care by partnering with medical device industry and ensuring that product safety & efficacy claims are supported by adequate clinical evidence in the most cost-effective manner • Core services ►Strategic Clinical Evidence Planning What, where, when, how ►Clinical evidence communication Reports, abstracts, M&S material and training ►Clinical project management Project design, progress, and (co-)monitoring

Empfohlen

Medical Devices Postmarket Surveillance in Europe updated
Medical Devices Postmarket Surveillance in Europe updatedMedical Devices Postmarket Surveillance in Europe updated
Medical Devices Postmarket Surveillance in Europe updatedAnnet Visscher
 
Sponsor Information and Training day Session A3 - Medical Devices: Post-marke...
Sponsor Information and Training day Session A3 - Medical Devices: Post-marke...Sponsor Information and Training day Session A3 - Medical Devices: Post-marke...
Sponsor Information and Training day Session A3 - Medical Devices: Post-marke...TGA Australia
 
CER - PMS - PMCF
CER - PMS - PMCFCER - PMS - PMCF
CER - PMS - PMCFKatarzyna Zofia Chrusciel
 
PMS and PMCF report
PMS and PMCF reportPMS and PMCF report
PMS and PMCF reportSakthisri87
 
Post marketing surveillance
Post marketing surveillancePost marketing surveillance
Post marketing surveillancesuraj mungase
 
Postmarket Surveillance Medical Devices
Postmarket Surveillance Medical DevicesPostmarket Surveillance Medical Devices
Postmarket Surveillance Medical DevicesJacobe2008
 
Clinical Evaluation Report for Medical Devices
Clinical Evaluation Report for Medical DevicesClinical Evaluation Report for Medical Devices
Clinical Evaluation Report for Medical DevicesI 3 Consulting
 
Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - ...
Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - ...Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - ...
Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - ...qserveconference2013
 

Empfohlen

Medical Devices Postmarket Surveillance in Europe updated
Medical Devices Postmarket Surveillance in Europe updatedMedical Devices Postmarket Surveillance in Europe updated
Medical Devices Postmarket Surveillance in Europe updatedAnnet Visscher
 
Sponsor Information and Training day Session A3 - Medical Devices: Post-marke...
Sponsor Information and Training day Session A3 - Medical Devices: Post-marke...Sponsor Information and Training day Session A3 - Medical Devices: Post-marke...
Sponsor Information and Training day Session A3 - Medical Devices: Post-marke...TGA Australia
 
CER - PMS - PMCF
CER - PMS - PMCFCER - PMS - PMCF
CER - PMS - PMCFKatarzyna Zofia Chrusciel
 
PMS and PMCF report
PMS and PMCF reportPMS and PMCF report
PMS and PMCF reportSakthisri87
 
Post marketing surveillance
Post marketing surveillancePost marketing surveillance
Post marketing surveillancesuraj mungase
 
Postmarket Surveillance Medical Devices
Postmarket Surveillance Medical DevicesPostmarket Surveillance Medical Devices
Postmarket Surveillance Medical DevicesJacobe2008
 
Clinical Evaluation Report for Medical Devices
Clinical Evaluation Report for Medical DevicesClinical Evaluation Report for Medical Devices
Clinical Evaluation Report for Medical DevicesI 3 Consulting
 
Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - ...
Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - ...Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - ...
Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - ...qserveconference2013
 
Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...
Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...
Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...qserveconference2013
 
Premarket Clinical Evaluation under the EU MDR proposal
Premarket Clinical Evaluation under the EU MDR proposalPremarket Clinical Evaluation under the EU MDR proposal
Premarket Clinical Evaluation under the EU MDR proposalAnnet Visscher
 
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...Levi Shapiro
 
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)clinical-evaluation-report (CER)
clinical-evaluation-report (CER)PEPGRA Healthcare
 
Medical device clinical evaluation
Medical device clinical evaluationMedical device clinical evaluation
Medical device clinical evaluationMalesh M
 
Presentation: Periodic safety update reports
Presentation: Periodic safety update reportsPresentation: Periodic safety update reports
Presentation: Periodic safety update reportsTGA Australia
 
Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance
Clinical Evaluation Report (CER) - Decode the Step-wise Approach for ComplianceClinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance
Clinical Evaluation Report (CER) - Decode the Step-wise Approach for ComplianceFreyr Solutions
 
How the TGA uses implant registry data: Experience with the Australian Orthop...
How the TGA uses implant registry data: Experience with the Australian Orthop...How the TGA uses implant registry data: Experience with the Australian Orthop...
How the TGA uses implant registry data: Experience with the Australian Orthop...TGA Australia
 
PSUR Requirements
PSUR RequirementsPSUR Requirements
PSUR RequirementsKonstantin Kachulev, MScPharm
 
Pharmacovigilance audit
Pharmacovigilance auditPharmacovigilance audit
Pharmacovigilance auditFernanda de Lima Ferreira
 
Post marketing surveillance april 2011
Post marketing surveillance april 2011Post marketing surveillance april 2011
Post marketing surveillance april 2011Erik Vollebregt
 
20210413 nvfg acs iso14155 13_apr2021
20210413 nvfg acs iso14155 13_apr202120210413 nvfg acs iso14155 13_apr2021
20210413 nvfg acs iso14155 13_apr2021Annet Visscher
 
Medical Device Clinical Studies and Protocol Design
Medical Device Clinical Studies and Protocol DesignMedical Device Clinical Studies and Protocol Design
Medical Device Clinical Studies and Protocol DesignMichael Swit
 
Overcoming the Challenges of Benefit Risk Assessment for Established Products
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsOvercoming the Challenges of Benefit Risk Assessment for Established Products
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
 
Presentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence GuidelinesPresentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence GuidelinesTGA Australia
 
Pharmacovigilance Legislation: Brazil in line with international standards
Pharmacovigilance Legislation: Brazil in line with international standardsPharmacovigilance Legislation: Brazil in line with international standards
Pharmacovigilance Legislation: Brazil in line with international standardsFernanda de Lima Ferreira
 
Presentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence GuidelinesPresentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence GuidelinesTGA Australia
 
Devices Sponsor Information Day: 0 - Developments in medical device regulation
Devices Sponsor Information Day: 0 - Developments in medical device regulationDevices Sponsor Information Day: 0 - Developments in medical device regulation
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
 
Minimizing Risk in Pharmacovigilance
Minimizing Risk in PharmacovigilanceMinimizing Risk in Pharmacovigilance
Minimizing Risk in PharmacovigilanceNeal Katz
 
Risk management plans - an overview
Risk management plans - an overviewRisk management plans - an overview
Risk management plans - an overviewTGA Australia
 
Materiovigilance programme of india by akhilesh sachan
Materiovigilance programme of india by akhilesh sachanMateriovigilance programme of india by akhilesh sachan
Materiovigilance programme of india by akhilesh sachanAkhilesh Sachan
 
Postmarket monitoring of therapeutic goods in Australia
Postmarket monitoring of therapeutic goods in AustraliaPostmarket monitoring of therapeutic goods in Australia
Postmarket monitoring of therapeutic goods in AustraliaTGA Australia
 

Weitere ähnliche Inhalte

Was ist angesagt?

Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...
Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...
Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...qserveconference2013
 
Premarket Clinical Evaluation under the EU MDR proposal
Premarket Clinical Evaluation under the EU MDR proposalPremarket Clinical Evaluation under the EU MDR proposal
Premarket Clinical Evaluation under the EU MDR proposalAnnet Visscher
 
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...Levi Shapiro
 
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)clinical-evaluation-report (CER)
clinical-evaluation-report (CER)PEPGRA Healthcare
 
Medical device clinical evaluation
Medical device clinical evaluationMedical device clinical evaluation
Medical device clinical evaluationMalesh M
 
Presentation: Periodic safety update reports
Presentation: Periodic safety update reportsPresentation: Periodic safety update reports
Presentation: Periodic safety update reportsTGA Australia
 
Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance
Clinical Evaluation Report (CER) - Decode the Step-wise Approach for ComplianceClinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance
Clinical Evaluation Report (CER) - Decode the Step-wise Approach for ComplianceFreyr Solutions
 
How the TGA uses implant registry data: Experience with the Australian Orthop...
How the TGA uses implant registry data: Experience with the Australian Orthop...How the TGA uses implant registry data: Experience with the Australian Orthop...
How the TGA uses implant registry data: Experience with the Australian Orthop...TGA Australia
 
Post marketing surveillance april 2011
Post marketing surveillance april 2011Post marketing surveillance april 2011
Post marketing surveillance april 2011Erik Vollebregt
 
20210413 nvfg acs iso14155 13_apr2021
20210413 nvfg acs iso14155 13_apr202120210413 nvfg acs iso14155 13_apr2021
20210413 nvfg acs iso14155 13_apr2021Annet Visscher
 
Medical Device Clinical Studies and Protocol Design
Medical Device Clinical Studies and Protocol DesignMedical Device Clinical Studies and Protocol Design
Medical Device Clinical Studies and Protocol DesignMichael Swit
 
Overcoming the Challenges of Benefit Risk Assessment for Established Products
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsOvercoming the Challenges of Benefit Risk Assessment for Established Products
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
 
Presentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence GuidelinesPresentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence GuidelinesTGA Australia
 
Pharmacovigilance Legislation: Brazil in line with international standards
Pharmacovigilance Legislation: Brazil in line with international standardsPharmacovigilance Legislation: Brazil in line with international standards
Pharmacovigilance Legislation: Brazil in line with international standardsFernanda de Lima Ferreira
 
Presentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence GuidelinesPresentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence GuidelinesTGA Australia
 
Devices Sponsor Information Day: 0 - Developments in medical device regulation
Devices Sponsor Information Day: 0 - Developments in medical device regulationDevices Sponsor Information Day: 0 - Developments in medical device regulation
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
 
Minimizing Risk in Pharmacovigilance
Minimizing Risk in PharmacovigilanceMinimizing Risk in Pharmacovigilance
Minimizing Risk in PharmacovigilanceNeal Katz
 
Risk management plans - an overview
Risk management plans - an overviewRisk management plans - an overview
Risk management plans - an overviewTGA Australia
 

Was ist angesagt? (20)

Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...
Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...
Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...
 
Premarket Clinical Evaluation under the EU MDR proposal
Premarket Clinical Evaluation under the EU MDR proposalPremarket Clinical Evaluation under the EU MDR proposal
Premarket Clinical Evaluation under the EU MDR proposal
 
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...
 
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)clinical-evaluation-report (CER)
clinical-evaluation-report (CER)
 
Medical device clinical evaluation
Medical device clinical evaluationMedical device clinical evaluation
Medical device clinical evaluation
 
Presentation: Periodic safety update reports
Presentation: Periodic safety update reportsPresentation: Periodic safety update reports
Presentation: Periodic safety update reports
 
Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance
Clinical Evaluation Report (CER) - Decode the Step-wise Approach for ComplianceClinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance
Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance
 
How the TGA uses implant registry data: Experience with the Australian Orthop...
How the TGA uses implant registry data: Experience with the Australian Orthop...How the TGA uses implant registry data: Experience with the Australian Orthop...
How the TGA uses implant registry data: Experience with the Australian Orthop...
 
PSUR Requirements
PSUR RequirementsPSUR Requirements
PSUR Requirements
 
Pharmacovigilance audit
Pharmacovigilance auditPharmacovigilance audit
Pharmacovigilance audit
 
Post marketing surveillance april 2011
Post marketing surveillance april 2011Post marketing surveillance april 2011
Post marketing surveillance april 2011
 
20210413 nvfg acs iso14155 13_apr2021
20210413 nvfg acs iso14155 13_apr202120210413 nvfg acs iso14155 13_apr2021
20210413 nvfg acs iso14155 13_apr2021
 
Medical Device Clinical Studies and Protocol Design
Medical Device Clinical Studies and Protocol DesignMedical Device Clinical Studies and Protocol Design
Medical Device Clinical Studies and Protocol Design
 
Overcoming the Challenges of Benefit Risk Assessment for Established Products
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsOvercoming the Challenges of Benefit Risk Assessment for Established Products
Overcoming the Challenges of Benefit Risk Assessment for Established Products
 
Presentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence GuidelinesPresentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence Guidelines
 
Pharmacovigilance Legislation: Brazil in line with international standards
Pharmacovigilance Legislation: Brazil in line with international standardsPharmacovigilance Legislation: Brazil in line with international standards
Pharmacovigilance Legislation: Brazil in line with international standards
 
Presentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence GuidelinesPresentation: Clinical Evidence Guidelines
Presentation: Clinical Evidence Guidelines
 
Devices Sponsor Information Day: 0 - Developments in medical device regulation
Devices Sponsor Information Day: 0 - Developments in medical device regulationDevices Sponsor Information Day: 0 - Developments in medical device regulation
Devices Sponsor Information Day: 0 - Developments in medical device regulation
 
Minimizing Risk in Pharmacovigilance
Minimizing Risk in PharmacovigilanceMinimizing Risk in Pharmacovigilance
Minimizing Risk in Pharmacovigilance
 
Risk management plans - an overview
Risk management plans - an overviewRisk management plans - an overview
Risk management plans - an overview
 

Andere mochten auch

Materiovigilance programme of india by akhilesh sachan
Materiovigilance programme of india by akhilesh sachanMateriovigilance programme of india by akhilesh sachan
Materiovigilance programme of india by akhilesh sachanAkhilesh Sachan
 
Postmarket monitoring of therapeutic goods in Australia
Postmarket monitoring of therapeutic goods in AustraliaPostmarket monitoring of therapeutic goods in Australia
Postmarket monitoring of therapeutic goods in AustraliaTGA Australia
 
How to Make Postmarket Surveillance More Cost Effective
How to Make Postmarket Surveillance More Cost EffectiveHow to Make Postmarket Surveillance More Cost Effective
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
 
The regulation of biologicals in Australia
The regulation of biologicals in AustraliaThe regulation of biologicals in Australia
The regulation of biologicals in AustraliaTGA Australia
 
An introduction to the work of Australia's regulator of therapeutic goods
An introduction to the work of Australia's regulator of therapeutic goodsAn introduction to the work of Australia's regulator of therapeutic goods
An introduction to the work of Australia's regulator of therapeutic goodsTGA Australia
 
Therapeutic Goods Administration By Bhavin Choradiya
Therapeutic Goods Administration By Bhavin ChoradiyaTherapeutic Goods Administration By Bhavin Choradiya
Therapeutic Goods Administration By Bhavin ChoradiyaBhavin Choradiya
 
Regulatory guidelines of Australia
Regulatory guidelines of AustraliaRegulatory guidelines of Australia
Regulatory guidelines of Australianandiniwarier93
 
The regulation of medicines in Australia
The regulation of medicines in AustraliaThe regulation of medicines in Australia
The regulation of medicines in AustraliaTGA Australia
 
Class newer routes of drug delivery
Class newer routes of drug deliveryClass newer routes of drug delivery
Class newer routes of drug deliveryRaghu Prasada
 
1ères rencontres autour des vigilances sanitaires : Intervention matériovigil...
1ères rencontres autour des vigilances sanitaires : Intervention matériovigil...1ères rencontres autour des vigilances sanitaires : Intervention matériovigil...
1ères rencontres autour des vigilances sanitaires : Intervention matériovigil...Vigipharm
 
Membrane transporters and drug response
Membrane transporters and drug responseMembrane transporters and drug response
Membrane transporters and drug responseAditi Panditrao
 
Newer drug delivery systems
Newer drug delivery systemsNewer drug delivery systems
Newer drug delivery systemsMandeep Sarma
 
Transporters as targets for drugs
Transporters as targets for drugsTransporters as targets for drugs
Transporters as targets for drugsshikha singh
 
Pharmacogenomics
PharmacogenomicsPharmacogenomics
Pharmacogenomicsshabrelhan
 
schedule y of drugs and cosmetic acts
schedule y of drugs and cosmetic actsschedule y of drugs and cosmetic acts
schedule y of drugs and cosmetic actsarponbiswas
 
Presentation: Therapeutic Goods Administration: An introduction to the work o...
Presentation: Therapeutic Goods Administration: An introduction to the work o...Presentation: Therapeutic Goods Administration: An introduction to the work o...
Presentation: Therapeutic Goods Administration: An introduction to the work o...TGA Australia
 

Andere mochten auch (20)

Materiovigilance programme of india by akhilesh sachan
Materiovigilance programme of india by akhilesh sachanMateriovigilance programme of india by akhilesh sachan
Materiovigilance programme of india by akhilesh sachan
 
Postmarket monitoring of therapeutic goods in Australia
Postmarket monitoring of therapeutic goods in AustraliaPostmarket monitoring of therapeutic goods in Australia
Postmarket monitoring of therapeutic goods in Australia
 
How to Make Postmarket Surveillance More Cost Effective
How to Make Postmarket Surveillance More Cost EffectiveHow to Make Postmarket Surveillance More Cost Effective
How to Make Postmarket Surveillance More Cost Effective
 
The regulation of biologicals in Australia
The regulation of biologicals in AustraliaThe regulation of biologicals in Australia
The regulation of biologicals in Australia
 
An introduction to the work of Australia's regulator of therapeutic goods
An introduction to the work of Australia's regulator of therapeutic goodsAn introduction to the work of Australia's regulator of therapeutic goods
An introduction to the work of Australia's regulator of therapeutic goods
 
Therapeutic Goods Administration By Bhavin Choradiya
Therapeutic Goods Administration By Bhavin ChoradiyaTherapeutic Goods Administration By Bhavin Choradiya
Therapeutic Goods Administration By Bhavin Choradiya
 
Regulatory guidelines of Australia
Regulatory guidelines of AustraliaRegulatory guidelines of Australia
Regulatory guidelines of Australia
 
The regulation of medicines in Australia
The regulation of medicines in AustraliaThe regulation of medicines in Australia
The regulation of medicines in Australia
 
mbbs ims msu
mbbs ims msumbbs ims msu
mbbs ims msu
 
Class newer routes of drug delivery
Class newer routes of drug deliveryClass newer routes of drug delivery
Class newer routes of drug delivery
 
1ères rencontres autour des vigilances sanitaires : Intervention matériovigil...
1ères rencontres autour des vigilances sanitaires : Intervention matériovigil...1ères rencontres autour des vigilances sanitaires : Intervention matériovigil...
1ères rencontres autour des vigilances sanitaires : Intervention matériovigil...
 
Membrane transporters and drug response
Membrane transporters and drug responseMembrane transporters and drug response
Membrane transporters and drug response
 
Newer drug delivery systems
Newer drug delivery systemsNewer drug delivery systems
Newer drug delivery systems
 
Transporters as targets for drugs
Transporters as targets for drugsTransporters as targets for drugs
Transporters as targets for drugs
 
Pharmacogenomics
PharmacogenomicsPharmacogenomics
Pharmacogenomics
 
newer drug delivery systems
newer drug delivery systemsnewer drug delivery systems
newer drug delivery systems
 
9 Karin Heidenreich - Novartis
9 Karin Heidenreich - Novartis9 Karin Heidenreich - Novartis
9 Karin Heidenreich - Novartis
 
schedule y of drugs and cosmetic acts
schedule y of drugs and cosmetic actsschedule y of drugs and cosmetic acts
schedule y of drugs and cosmetic acts
 
Presentation: Therapeutic Goods Administration: An introduction to the work o...
Presentation: Therapeutic Goods Administration: An introduction to the work o...Presentation: Therapeutic Goods Administration: An introduction to the work o...
Presentation: Therapeutic Goods Administration: An introduction to the work o...
 
Smart Drug Delivery Systems
Smart Drug Delivery SystemsSmart Drug Delivery Systems
Smart Drug Delivery Systems
 

Ähnlich wie Medical Devices Postmarket Surveillance 14 jul13

POST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICES
POST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICESPOST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICES
POST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICESSharvilModi
 
Post-Market Clinical Follow Up Studies Under EU MDR and IVDR
Post-Market Clinical Follow Up Studies Under EU MDR and IVDRPost-Market Clinical Follow Up Studies Under EU MDR and IVDR
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
 
Clinical data management
Clinical data managementClinical data management
Clinical data managementAjay Murali
 
Presentation: Draft Clinical Evidence Guidelines – Medical Devices
Presentation: Draft Clinical Evidence Guidelines – Medical DevicesPresentation: Draft Clinical Evidence Guidelines – Medical Devices
Presentation: Draft Clinical Evidence Guidelines – Medical DevicesTGA Australia
 
EU Clinical Investigations Taipei 2018
EU Clinical Investigations Taipei 2018EU Clinical Investigations Taipei 2018
EU Clinical Investigations Taipei 2018Annet Visscher
 
Design for reimbursement in medical device development
Design for reimbursement in medical device developmentDesign for reimbursement in medical device development
Design for reimbursement in medical device developmentAmber Hol Horeman
 
Current Trends in Clinical Trial Design and Execution
Current Trends in Clinical Trial Design and Execution Current Trends in Clinical Trial Design and Execution
Current Trends in Clinical Trial Design and Execution ClinosolIndia
 
Understanding The Increasing Impact Of Clinical Research On Obtaining Product...
Understanding The Increasing Impact Of Clinical Research On Obtaining Product...Understanding The Increasing Impact Of Clinical Research On Obtaining Product...
Understanding The Increasing Impact Of Clinical Research On Obtaining Product...Gertwbos
 
Medical Devices Regulation (MDR) 2017/745 - Clinical Evaluation & Post-Marke...
Medical Devices Regulation (MDR) 2017/745 - Clinical Evaluation & Post-Marke...Medical Devices Regulation (MDR) 2017/745 - Clinical Evaluation & Post-Marke...
Medical Devices Regulation (MDR) 2017/745 - Clinical Evaluation & Post-Marke...Arete-Zoe, LLC
 
Clinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcareClinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcarePEPGRA Healthcare
 
The regulation of medical devices in Australia
The regulation of medical devices in AustraliaThe regulation of medical devices in Australia
The regulation of medical devices in AustraliaTGA Australia
 
Risk Based Monitoring in Clinical trials_Aishwarya Janjale.pptx
Risk Based Monitoring in Clinical trials_Aishwarya Janjale.pptxRisk Based Monitoring in Clinical trials_Aishwarya Janjale.pptx
Risk Based Monitoring in Clinical trials_Aishwarya Janjale.pptxClinosolIndia
 
KCR: Cost effectiveness in clinical trials
KCR: Cost effectiveness in clinical trialsKCR: Cost effectiveness in clinical trials
KCR: Cost effectiveness in clinical trialsKCR
 
8. Public Health Surveillance - Copy.pptx
8. Public Health Surveillance - Copy.pptx8. Public Health Surveillance - Copy.pptx
8. Public Health Surveillance - Copy.pptxEtalemBurako
 
Decentralized Monitoring in Clinical Trials
Decentralized Monitoring in Clinical TrialsDecentralized Monitoring in Clinical Trials
Decentralized Monitoring in Clinical TrialsClinosolIndia
 
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trial Desi...
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trial Desi...FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trial Desi...
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trial Desi...MedicReS
 

Ähnlich wie Medical Devices Postmarket Surveillance 14 jul13 (20)

Project Cost management in pharmaceuticals
Project Cost management in pharmaceuticalsProject Cost management in pharmaceuticals
Project Cost management in pharmaceuticals
 
POST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICES
POST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICESPOST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICES
POST-MARKET CLINICAL FOLLOW UP STUDIES FOR MEDICAL DEVICES
 
Post-Market Clinical Follow Up Studies Under EU MDR and IVDR
Post-Market Clinical Follow Up Studies Under EU MDR and IVDRPost-Market Clinical Follow Up Studies Under EU MDR and IVDR
Post-Market Clinical Follow Up Studies Under EU MDR and IVDR
 
Clinical data management
Clinical data managementClinical data management
Clinical data management
 
Presentation: Draft Clinical Evidence Guidelines – Medical Devices
Presentation: Draft Clinical Evidence Guidelines – Medical DevicesPresentation: Draft Clinical Evidence Guidelines – Medical Devices
Presentation: Draft Clinical Evidence Guidelines – Medical Devices
 
EU Clinical Investigations Taipei 2018
EU Clinical Investigations Taipei 2018EU Clinical Investigations Taipei 2018
EU Clinical Investigations Taipei 2018
 
Final presentation 20150709
Final presentation 20150709Final presentation 20150709
Final presentation 20150709
 
Design for reimbursement in medical device development
Design for reimbursement in medical device developmentDesign for reimbursement in medical device development
Design for reimbursement in medical device development
 
Current Trends in Clinical Trial Design and Execution
Current Trends in Clinical Trial Design and Execution Current Trends in Clinical Trial Design and Execution
Current Trends in Clinical Trial Design and Execution
 
Understanding The Increasing Impact Of Clinical Research On Obtaining Product...
Understanding The Increasing Impact Of Clinical Research On Obtaining Product...Understanding The Increasing Impact Of Clinical Research On Obtaining Product...
Understanding The Increasing Impact Of Clinical Research On Obtaining Product...
 
Medical Devices Regulation (MDR) 2017/745 - Clinical Evaluation & Post-Marke...
Medical Devices Regulation (MDR) 2017/745 - Clinical Evaluation & Post-Marke...Medical Devices Regulation (MDR) 2017/745 - Clinical Evaluation & Post-Marke...
Medical Devices Regulation (MDR) 2017/745 - Clinical Evaluation & Post-Marke...
 
Clinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcareClinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
Clinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
 
The regulation of medical devices in Australia
The regulation of medical devices in AustraliaThe regulation of medical devices in Australia
The regulation of medical devices in Australia
 
Risk Based Monitoring in Clinical trials_Aishwarya Janjale.pptx
Risk Based Monitoring in Clinical trials_Aishwarya Janjale.pptxRisk Based Monitoring in Clinical trials_Aishwarya Janjale.pptx
Risk Based Monitoring in Clinical trials_Aishwarya Janjale.pptx
 
Marco Cavaleri: Post-approval benefit risk monitoring of vaccines: EMA perspe...
Marco Cavaleri: Post-approval benefit risk monitoring of vaccines: EMA perspe...Marco Cavaleri: Post-approval benefit risk monitoring of vaccines: EMA perspe...
Marco Cavaleri: Post-approval benefit risk monitoring of vaccines: EMA perspe...
 
KCR: Cost effectiveness in clinical trials
KCR: Cost effectiveness in clinical trialsKCR: Cost effectiveness in clinical trials
KCR: Cost effectiveness in clinical trials
 
Jornadas #PatientInHTA · Jesús González
Jornadas #PatientInHTA · Jesús GonzálezJornadas #PatientInHTA · Jesús González
Jornadas #PatientInHTA · Jesús González
 
8. Public Health Surveillance - Copy.pptx
8. Public Health Surveillance - Copy.pptx8. Public Health Surveillance - Copy.pptx
8. Public Health Surveillance - Copy.pptx
 
Decentralized Monitoring in Clinical Trials
Decentralized Monitoring in Clinical TrialsDecentralized Monitoring in Clinical Trials
Decentralized Monitoring in Clinical Trials
 
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trial Desi...
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trial Desi...FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trial Desi...
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trial Desi...
 

Kürzlich hochgeladen

Q4-PPT-Music9_Lesson-1-Romantic-Opera.pptx
Q4-PPT-Music9_Lesson-1-Romantic-Opera.pptxQ4-PPT-Music9_Lesson-1-Romantic-Opera.pptx
Q4-PPT-Music9_Lesson-1-Romantic-Opera.pptxlancelewisportillo
 
Concurrency Control in Database Management system
Concurrency Control in Database Management systemConcurrency Control in Database Management system
Concurrency Control in Database Management systemChristalin Nelson
 
Visit to a blind student's school🧑‍🦯🧑‍🦯(community medicine)
Visit to a blind student's school🧑‍🦯🧑‍🦯(community medicine)Visit to a blind student's school🧑‍🦯🧑‍🦯(community medicine)
Visit to a blind student's school🧑‍🦯🧑‍🦯(community medicine)lakshayb543
 
How to do quick user assign in kanban in Odoo 17 ERP
How to do quick user assign in kanban in Odoo 17 ERPHow to do quick user assign in kanban in Odoo 17 ERP
How to do quick user assign in kanban in Odoo 17 ERPCeline George
 
The Contemporary World: The Globalization of World Politics
The Contemporary World: The Globalization of World PoliticsThe Contemporary World: The Globalization of World Politics
The Contemporary World: The Globalization of World PoliticsRommel Regala
 
Oppenheimer Film Discussion for Philosophy and Film
Oppenheimer Film Discussion for Philosophy and FilmOppenheimer Film Discussion for Philosophy and Film
Oppenheimer Film Discussion for Philosophy and FilmStan Meyer
 
ROLES IN A STAGE PRODUCTION in arts.pptx
ROLES IN A STAGE PRODUCTION in arts.pptxROLES IN A STAGE PRODUCTION in arts.pptx
ROLES IN A STAGE PRODUCTION in arts.pptxVanesaIglesias10
 
Keynote by Prof. Wurzer at Nordex about IP-design
Keynote by Prof. Wurzer at Nordex about IP-designKeynote by Prof. Wurzer at Nordex about IP-design
Keynote by Prof. Wurzer at Nordex about IP-designMIPLM
 
Choosing the Right CBSE School A Comprehensive Guide for Parents
Choosing the Right CBSE School A Comprehensive Guide for ParentsChoosing the Right CBSE School A Comprehensive Guide for Parents
Choosing the Right CBSE School A Comprehensive Guide for Parentsnavabharathschool99
 
MULTIDISCIPLINRY NATURE OF THE ENVIRONMENTAL STUDIES.pptx
MULTIDISCIPLINRY NATURE OF THE ENVIRONMENTAL STUDIES.pptxMULTIDISCIPLINRY NATURE OF THE ENVIRONMENTAL STUDIES.pptx
MULTIDISCIPLINRY NATURE OF THE ENVIRONMENTAL STUDIES.pptxAnupkumar Sharma
 
ICS2208 Lecture6 Notes for SL spaces.pdf
ICS2208 Lecture6 Notes for SL spaces.pdfICS2208 Lecture6 Notes for SL spaces.pdf
ICS2208 Lecture6 Notes for SL spaces.pdfVanessa Camilleri
 
TEACHER REFLECTION FORM (NEW SET........).docx
TEACHER REFLECTION FORM (NEW SET........).docxTEACHER REFLECTION FORM (NEW SET........).docx
TEACHER REFLECTION FORM (NEW SET........).docxruthvilladarez
 
Activity 2-unit 2-update 2024. English translation
Activity 2-unit 2-update 2024. English translationActivity 2-unit 2-update 2024. English translation
Activity 2-unit 2-update 2024. English translationRosabel UA
 
AUDIENCE THEORY -CULTIVATION THEORY - GERBNER.pptx
AUDIENCE THEORY -CULTIVATION THEORY - GERBNER.pptxAUDIENCE THEORY -CULTIVATION THEORY - GERBNER.pptx
AUDIENCE THEORY -CULTIVATION THEORY - GERBNER.pptxiammrhaywood
 
Millenials and Fillennials (Ethical Challenge and Responses).pptx
Millenials and Fillennials (Ethical Challenge and Responses).pptxMillenials and Fillennials (Ethical Challenge and Responses).pptx
Millenials and Fillennials (Ethical Challenge and Responses).pptxJanEmmanBrigoli
 
Grade 9 Quarter 4 Dll Grade 9 Quarter 4 DLL.pdf
Grade 9 Quarter 4 Dll Grade 9 Quarter 4 DLL.pdfGrade 9 Quarter 4 Dll Grade 9 Quarter 4 DLL.pdf
Grade 9 Quarter 4 Dll Grade 9 Quarter 4 DLL.pdfJemuel Francisco
 
USPS® Forced Meter Migration - How to Know if Your Postage Meter Will Soon be...
USPS® Forced Meter Migration - How to Know if Your Postage Meter Will Soon be...USPS® Forced Meter Migration - How to Know if Your Postage Meter Will Soon be...
USPS® Forced Meter Migration - How to Know if Your Postage Meter Will Soon be...Postal Advocate Inc.
 
Influencing policy (training slides from Fast Track Impact)
Influencing policy (training slides from Fast Track Impact)Influencing policy (training slides from Fast Track Impact)
Influencing policy (training slides from Fast Track Impact)Mark Reed
 
EMBODO Lesson Plan Grade 9 Law of Sines.docx
EMBODO Lesson Plan Grade 9 Law of Sines.docxEMBODO Lesson Plan Grade 9 Law of Sines.docx
EMBODO Lesson Plan Grade 9 Law of Sines.docxElton John Embodo
 

Kürzlich hochgeladen (20)

Q4-PPT-Music9_Lesson-1-Romantic-Opera.pptx
Q4-PPT-Music9_Lesson-1-Romantic-Opera.pptxQ4-PPT-Music9_Lesson-1-Romantic-Opera.pptx
Q4-PPT-Music9_Lesson-1-Romantic-Opera.pptx
 
Concurrency Control in Database Management system
Concurrency Control in Database Management systemConcurrency Control in Database Management system
Concurrency Control in Database Management system
 
Visit to a blind student's school🧑‍🦯🧑‍🦯(community medicine)
Visit to a blind student's school🧑‍🦯🧑‍🦯(community medicine)Visit to a blind student's school🧑‍🦯🧑‍🦯(community medicine)
Visit to a blind student's school🧑‍🦯🧑‍🦯(community medicine)
 
How to do quick user assign in kanban in Odoo 17 ERP
How to do quick user assign in kanban in Odoo 17 ERPHow to do quick user assign in kanban in Odoo 17 ERP
How to do quick user assign in kanban in Odoo 17 ERP
 
The Contemporary World: The Globalization of World Politics
The Contemporary World: The Globalization of World PoliticsThe Contemporary World: The Globalization of World Politics
The Contemporary World: The Globalization of World Politics
 
Oppenheimer Film Discussion for Philosophy and Film
Oppenheimer Film Discussion for Philosophy and FilmOppenheimer Film Discussion for Philosophy and Film
Oppenheimer Film Discussion for Philosophy and Film
 
ROLES IN A STAGE PRODUCTION in arts.pptx
ROLES IN A STAGE PRODUCTION in arts.pptxROLES IN A STAGE PRODUCTION in arts.pptx
ROLES IN A STAGE PRODUCTION in arts.pptx
 
Keynote by Prof. Wurzer at Nordex about IP-design
Keynote by Prof. Wurzer at Nordex about IP-designKeynote by Prof. Wurzer at Nordex about IP-design
Keynote by Prof. Wurzer at Nordex about IP-design
 
Choosing the Right CBSE School A Comprehensive Guide for Parents
Choosing the Right CBSE School A Comprehensive Guide for ParentsChoosing the Right CBSE School A Comprehensive Guide for Parents
Choosing the Right CBSE School A Comprehensive Guide for Parents
 
MULTIDISCIPLINRY NATURE OF THE ENVIRONMENTAL STUDIES.pptx
MULTIDISCIPLINRY NATURE OF THE ENVIRONMENTAL STUDIES.pptxMULTIDISCIPLINRY NATURE OF THE ENVIRONMENTAL STUDIES.pptx
MULTIDISCIPLINRY NATURE OF THE ENVIRONMENTAL STUDIES.pptx
 
ICS2208 Lecture6 Notes for SL spaces.pdf
ICS2208 Lecture6 Notes for SL spaces.pdfICS2208 Lecture6 Notes for SL spaces.pdf
ICS2208 Lecture6 Notes for SL spaces.pdf
 
TEACHER REFLECTION FORM (NEW SET........).docx
TEACHER REFLECTION FORM (NEW SET........).docxTEACHER REFLECTION FORM (NEW SET........).docx
TEACHER REFLECTION FORM (NEW SET........).docx
 
Activity 2-unit 2-update 2024. English translation
Activity 2-unit 2-update 2024. English translationActivity 2-unit 2-update 2024. English translation
Activity 2-unit 2-update 2024. English translation
 
AUDIENCE THEORY -CULTIVATION THEORY - GERBNER.pptx
AUDIENCE THEORY -CULTIVATION THEORY - GERBNER.pptxAUDIENCE THEORY -CULTIVATION THEORY - GERBNER.pptx
AUDIENCE THEORY -CULTIVATION THEORY - GERBNER.pptx
 
Millenials and Fillennials (Ethical Challenge and Responses).pptx
Millenials and Fillennials (Ethical Challenge and Responses).pptxMillenials and Fillennials (Ethical Challenge and Responses).pptx
Millenials and Fillennials (Ethical Challenge and Responses).pptx
 
Grade 9 Quarter 4 Dll Grade 9 Quarter 4 DLL.pdf
Grade 9 Quarter 4 Dll Grade 9 Quarter 4 DLL.pdfGrade 9 Quarter 4 Dll Grade 9 Quarter 4 DLL.pdf
Grade 9 Quarter 4 Dll Grade 9 Quarter 4 DLL.pdf
 
USPS® Forced Meter Migration - How to Know if Your Postage Meter Will Soon be...
USPS® Forced Meter Migration - How to Know if Your Postage Meter Will Soon be...USPS® Forced Meter Migration - How to Know if Your Postage Meter Will Soon be...
USPS® Forced Meter Migration - How to Know if Your Postage Meter Will Soon be...
 
Paradigm shift in nursing research by RS MEHTA
Paradigm shift in nursing research by RS MEHTAParadigm shift in nursing research by RS MEHTA
Paradigm shift in nursing research by RS MEHTA
 
Influencing policy (training slides from Fast Track Impact)
Influencing policy (training slides from Fast Track Impact)Influencing policy (training slides from Fast Track Impact)
Influencing policy (training slides from Fast Track Impact)
 
EMBODO Lesson Plan Grade 9 Law of Sines.docx
EMBODO Lesson Plan Grade 9 Law of Sines.docxEMBODO Lesson Plan Grade 9 Law of Sines.docx
EMBODO Lesson Plan Grade 9 Law of Sines.docx
 

Medical Devices Postmarket Surveillance 14 jul13

  • 1. Annet Muetstege Postmarket Surveillance made simpel| Westervoort, 06 July 2013
  • 2. 6 Jul 2013 ACS PMS 2 Reportable Adverse Event? • Serious? • Device related? • Unanticipated?
  • 3. 6 Jul 2013 ACS PMS 3 Medical Devices: a diverse sector
  • 4. 6 Jul 2013 ACS PMS 4 Medical Device Regulation Proposal - Postmarket Surveillance ″ Proportionate to the risk class and the type of device, manufacturers … shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market … and to apply any necessary corrective action, hereinafter referred to as ‘post-market surveillance plan’. • “Post-market clinical follow-up, … a continuous process to update the clinical evaluation referred to in Article 49 and Part A of this Annex and shall be part of the manufacturer's post-market surveillance plan… the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which is authorised to bear the CE marking, within its intended purpose … with the aim of confirming the safety and performance throughout …”
  • 5. 6 Jul 2013 ACS PMS 5 Medical Device Regulation Proposal - Postmarket Clinical Follow-up ″ … PMCF shall be performed pursuant to a documented method laid down in a PMCF plan … ″ specify general methods and procedures, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data … ″ The notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan.”
  • 6. 6 Jul 2013 ACS PMS 6 PMCF - Vigilance ″ … European system for the notification and evaluation of incidents and field safety corrective actions … • Advantage ►Existing company system ►Low additional cost • Challenges ►Reactive ►Issues late in the game (1) MEDDEV 2.12-1 rev 8
  • 7. 6 Jul 2013 ACS PMS 7 PMCF - Literature review ″ The process of reading, analyzing, evaluating, and summarizing scholarly materials about a specific topic.” • Options ►Review relevant sources at regular intervals, e.g. PubMed ►Conferences ►Journal alerting Services • Advantage ►Relatively cheap ►Access to data world wide • Challenges ►Reactive ►Data typically limited and heterogeneous
  • 8. 6 Jul 2013 ACS PMS 8 PMCF - Studies • Options ►Non-interventional – registries ″ A collection of clinical data where all subjects receive the standard hospital treatment and have a parameter of interest in common ►Interventional – RCT ″ Clinical study where participants receive treatment's or test's different from standard practice because of study participation. Such treatment may concern randomization.
  • 9. 6 Jul 2013 ACS PMS 9 PMCF – Registry • Options – several ►Paper/ EDC forms ►Single/ multi center ►… • Advantages ►Value for money ►Low site threshold ►… • Challenges ►No efficacy/ added value data
  • 10. 6 Jul 2013 ACS PMS 10 PMCF – Interventional Study • Options ►Small scale single arm ►RCT • Advantages ►Efficacy and/ or added value ►RCT is gold standard • Challenges ►Not daily practice ►Huge investment ►Blinding
  • 11. 6 Jul 2013 ACS PMS 11 Postmarket Surveillance - Conclusion • PMS under new MDR ►More stringent, and controlled • Various options ►Standard company processes ►Literature review ►Registries ►Randomised Controlled Studies ►…
  • 12. 6 Jul 2013 ACS PMS 12 Questions? Applied Clinical Services BV www.appliedclinicalservices.com info@appliedclinicalservices.com +31 26 848 5281
  • 13. 6 Jul 2013 ACS PMS 13 Applied Clinical Services BV • Co-founded by Annet Muetstege • Mission ► To contribute to better patient outcomes in health care by partnering with medical device industry and ensuring that product safety & efficacy claims are supported by adequate clinical evidence in the most cost-effective manner • Core services ►Strategic Clinical Evidence Planning What, where, when, how ►Clinical evidence communication Reports, abstracts, M&S material and training ►Clinical project management Project design, progress, and (co-)monitoring