Update on WHO Prequalification of In Vitro Diagnostics
|
|
- Alexina Hutchinson
- 6 years ago
- Views:
Transcription
1 Update on WHO Prequalification of In Vitro Diagnostics Robyn Meurant and Mercedes Perez Gonzalez Prequalification Team Diagnostics Assessment Essential Medicines and Health Products World Health Organization Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers of in vitro diagnostics, vaccines, finished pharmaceutical products, active pharmaceutical ingredients, contraceptive devices and vector control products Copenhagen, Denmark 18 to 21 September 2017 Copenhagen, Denmark September
2 2015 Update Improved aspect Impact Outstanding challenges Solutions for challenges Progress Streamlined process Focus on active applications, minimize effort into immature applications, assess more products, expanded programme scope High priority products with immature applications / impact on overall timelines Guidance, sample dossiers, technical assistance and training, TCs, WebEx Expanded network for performance evaluations Less burden for WHO CCs, wider utilisation of PQ outcomes through USAID Timelines for specific technologies still challenging Future laboratory evaluation pathway Adoption of IMDRF principles Alignment with best international practice and reliance MDSAP still in pilot, industry concerns over ToC/RPS Further collaboration with IMDRF and other harmonization WPs Implemented changes assessment and PMS reporting Better insight in post-pq phase Underreporting on vigilance, variable compliance for changes notifications Updated changes assessment procedure, PMS WebEx, PMS training 2
3 2017 Progress Report Improved aspect Impact Outstanding challenges Solutions for challenges Progress Streamlined process Focus on active applications, minimize effort into immature applications, assess more products, expanded programme scope High priority products with immature applications / impact on overall timelines Guidance, sample dossiers, technical assistance and training, TCs, WebEx Expanded network for performance evaluations Less burden for WHO CCs, wider utilisation of PQ outcomes through USAID Timelines for specific technologies still challenging Future laboratory evaluation pathway Adoption of IMDRF principles Alignment with best international practice and reliance MDSAP still in pilot, industry concerns over ToC/RPS Further collaboration with IMDRF and other harmonization WPs Implemented changes assessment and PMS reporting Better insight in post-pq phase Underreporting on vigilance, variable compliance for changes notifications Updated changes assessment procedure, PMS WebEx, PMS training 3
4 Streamlined process Improved aspect Impact Outstanding challenges Solutions for challenges Progress Streamlined process Focus on active applications, minimize effort into immature applications, assess more products, expanded programme scope High priority products with immature applications / impact on overall timelines Guidance, sample dossiers, technical assistance and training, TCs, WebEx
5 Streamlined process Pre-submission form Eligible product Yes No Dossier screening Laboratory evaluation Dossier incomplete Dossier complete Dossier review Site inspection PREQUALIFICATION DECISION Maintenance of PQ Status
6 Abridged Procedure Pre-submission form Eligible product Yes No Site inspection Laboratory evaluation PREQUALIFICATION DECISION Maintenance of PQ Status
7 Abridged Procedure Pre-submission form Dossier Aspects Eligible product Yes No Site inspection Laboratory evaluation PREQUALIFICATION DECISION Maintenance of PQ Status
8 Updates Increase in the number of malaria manufacturers applying for WHO PQ Increase in the number of abridged PQ assessments Assessment of dossier aspects as part of the site inspection Innovative products and new manufacturers continue to apply to PQ Addition of new diseases requiring full PQ assessment
9 WHO Prequalified IVDs Products currently prequalified HIV RDTs 16 HIV NAT Quantitative and qualitative 15 Overall Prequalified products: 67 IVDs HIV Confirmatory Assays 3 HIV EIAs 13 HCV RDT 2 HCV NAT 1 HCV EIAs 3 HBsAg EIA 4 HIV/syphilis 1 CD4 Technologies 5 Malaria 12
10 Highlights Prequalification: Prequalification of two HIV EID technologies: Performance evaluation conducted as a collaboration between WHO, NHLS and CDC under USAID/PEPFAR-WHO common quality assurance mechanism. Prequalification of the first two HCV rapid diagnostic tests Prequalification of a HCV viral load assay Prequalification of the first HIV Self Test
11 Highlights PQ scope expanded to include In 2016: HIV assays intended for self-testing G6PD assays (for administration of primaquine and tafenoquine for radical cure of P. vivax) In 2017 (applications to be accepted 1 January 2018): Cholera RDTs
12 Highlights New set of PQ documents Overview of the WHO PQ of IVDs Assessment PQ Assessment and Change Assessment Target Deadlines PQ Assessment and Changes Assessment Fees Eligibility Criteria for WHO PQ of IVDs Presubmission form IVDs
13 Purpose of the dossier unique characteristics Demonstrate that the manufacturer has considered the quality, safety and performance of in the countries where WHO PQ IVDs are procured Programmatic suitability: specific emphasis on issues of particular relevance to resource-limited settings, such as: Stability of products (heat conditions) Adapted specimen type Labelling of products Ease of use (in terms of training and material) Performance evaluated in the global population Life cycle management of products 13
14 Update on dossier assessment WHO perspective PQ working to increase transparency for manufacturers: through publication of WHO requirements, revision of WHO documents and alignment with other organizations, for example: Technical Specification Series Technical Guidance series Consultation with international experts on requirements for new eligible IVDs Influence on the development of new International Standards and reference panels Plans to update current Instructions for compilation of a product dossier 14
15 Highlights cont d Technical Guidance Series: Standards applicable to the WHO Prequalification of IVDs Establishing stability of an IVD for the WHO Prequalification Principles of performance studies Test method validation of IVDs DRAFT Designing Instructions for use for IVDs DRAFT Panels for quality assurance and quality control of IVDs Sample dossiers: Sample Product Dossier for a CD4 IVD Sample Product Dossier for an IVD intended for HIV self-testing Sample Product Dossier for a Qualitative NAT to detect HIV-1 and HIV-2 Sample Product Dossier for a Quantitative NAT to detect HIV-1 RNA Technical Specifications Series: HIV rapid diagnostic tests for professional use and/or self-testing Glucose-6-phosphate dehydrogenase (G6PD) activity Malaria rapid diagnostic tests DRAFT Detection of high-risk HPV genotypes in cervical cancer screening
16 Highlights cont d Dossier Assessors Training: Training sessions provided to WHO PQ assessors to ensure consistency and equity in the review process. Provided by WHO and by partner laboratories with experience in PQ activities Dossier assessors trained in assessing data quality and data integrity Aim is not to fail a good product! Commitments to PQ: Developing a rating system based on the severity of the dossier requirement If non severe, results in a commitment to PQ Generally compliance reviewed at inspection
17 2017 Progress Report Improved aspect Impact Outstanding challenges Solutions for challenges Progress Expanded network for performance evaluations Less burden for WHO CCs, wider utilisation of PQ outcomes through USAID Timelines for specific technologies still challenging Future laboratory evaluation pathway 17
18 Alternative mechanism for WHO PQ performance evaluation Pre-submission form Change in evaluations scheduling: Priority product Shift from assessment to pre-assessment phase to streamline assessment activities and avoid sequential steps Option 2: Performance evaluation scheduled by Mx and conducted by a Prequalification Evaluating Laboratory. Dossier incomplete Dossier screening Option 1: Performance evaluation scheduled by WHO and conducted by a Prequalification Evaluating Laboratory. Dossier complete Dossier review Site inspection Prequalification decision Copenhagen, Denmark September
19 Alternative mechanism for WHO PQ performance evaluation Manufacturers free to choose one of two performance evaluations pathways: Option 1: Performance evaluation coordinated by WHO Option 2: Performance evaluation commissioned by the manufacturer and carried out at a Prequalification Evaluating Laboratory listed by WHO Key principles All evaluations carried out following WHO protocol All sites audited and listed by WHO Manufacturers free to choose the pathway Copenhagen, Denmark September
20 Alternative mechanism for WHO PQ performance evaluation cont d WHO is auditing laboratories against predefined requirements based on ISO and ISO applications received 9 laboratories audited 6 laboratories already listed 2 lists of laboratories: List 1 - laboratories work directly with WHO and participate in Option 1 List 2 laboratories that work directly with manufacturers and participate in Option 2 Copenhagen, Denmark September
21 Update on PQ performance evaluations of NATbased technologies Progress in 2017 Completed evaluation: 9 Ongoing evaluations: 1 Scheduled: 2 Issues to note Challenge to obtain certain types of specimens: Viral load ranges Infant specimens Certain genotypes Evaluations involve instruments adding complexity: training required, possible breakdowns, space Copenhagen, Denmark September
22 Performance evaluation of HIV Ab/Ag, HIV/Syphilis, HIV oral fluid, HBsAg, HCV, CD4 technologies Progress in 2017 Completed evaluations: 64 Ongoing evaluations: 4 (2 HIV serology, 1 CD4 and 1 HBsAg) Scheduled: 4 (1 self-testing, 2 CD4) Issues to note HBsAg limit of detection of 0.13 IU/ml for RDTs Obtaining ethical clearance in prospective studies (CD4, self-testing (capillary whole blood) Use of similar clinical samples when evaluation will be conducted in new labs listed in ALE Copenhagen, Denmark September
23 2017 Progress Report Improved aspect Impact Outstanding challenges Solutions for challenges Progress Adoption of IMDRF principles Alignment with best international practice and reliance MDSAP still in pilot, industry concerns over ToC/RPS Further collaboration with IMDRF and other harmonization WPs 23
24 Harmonisation and PQ adoption activities Adoption of the IMDRF Table of Contents Input into the IMRDF Good regulatory review practice Input into the IMDRF Adverse event terminology Input into the IMDRF Common data elements Participation in the IVD working group of the Asian Harmonisation Working Party 24
25 2017 Progress Report Improved aspect Impact Outstanding challenges Solutions for challenges Progress Implemented changes assessment and PMS reporting Better insight in post-pq phase Underreporting on vigilance, variable compliance for changes notifications Updated changes assessment procedure PMS WebEx, PMS training 25
26 Post-qualification activities Revised guidance: Reportable changes to a prequalified IVD medical device changes to the prequalified product or its manufacture; changes to the Quality Management System (QMS) that the product was designed and manufactured under; and/or other reportable administrative changes. Changes identified as reportable or non reportable c.f. first version (minor or substantial). Provides greater clarity on what to report List of generic examples. Increased compliance, however, some manufacturers still implement changes prior to notification
27 Status of WHO complaint monitoring activities 59 complaints submitted to WHO since Nov complaints were for NAT technologies Signals came from both high and low resource settings Typically, the FSCAs were revised labelling and recall/destruction of certain lots A number of complaints have led to change notifications (revised manufacturing process, etc.) False negative Total complaints reported to WHO, by type False negative and false positive False positive Falsification Invalid rate Mislabelled Unreturnable result Defective reagent Weak reactivity Software Defective reagent Importantly, 4 complaints for falsified products reported
28 Handling complaints for NAT Complaints for NAT technologies High rate of invalid results Misclassification (downwards bias) for dried blood spot specimens Typical corrective actions Change to manufacturing and/or QC process Change of key supplier Enhanced detail of IFU, e.g. for specimen collection, warnings, etc. The expiry date was changed from to
29 Global Diagnostics Working Group Global Diagnostics Working Group will establish a subgroup on post-market surveillance to: Exchange of information on complaints Enable coordinated action by GDWG and their partners 29
30 Where to find information Contact us by Sign up for our mailing list By ing Check our website atory/evaluations/en/
Introduction to PQDx assessment update. Irena Prat, Group Lead Prequalification Team Diagnostics assessment
Introduction to PQDx assessment update Irena Prat, Group Lead Prequalification Team Diagnostics assessment Copenhagen, Denmark 24 27 September 2018 1 Introduction of Diagnostics assessment Team Copenhagen,
More informationGlobal Diagnostics Working Group
Global Diagnostics Working Group AMDS Meeting with Stakeholders and Manufacturers, 2016 Anita SANDS, on behalf of the GDWG Why a GDWG? In the wake of a global product alert for a specific product all agencies
More informationWHO Prequalification of In Vitro Diagnostics Programme
WHO Prequalification of In Vitro Diagnostics Programme International HIV/Viral Hepatitis Co-Infection Satellite Meeting 19 July 2014, Melbourne Anita Sands Prequalification Diagnostics Team Department
More informationUpdate on WHO Prequalification of IVDs
Update on WHO Prequalification of IVDs Geneva, 11 March 2016 Mercedes Perez Gonzalez Anita Sands Prequalification Team - Diagnostics World Health Organization Outline Progress and Pipeline Ongoing concerns
More informationVaccine assessment for prequalification
Vaccine assessment for prequalification Briefing on Vaccine Prequalification for manufacturers DCVMN meeting, Kunming, China, 13 March 2016 Olivier Lapujade World Health Organization, EMP/RHT/PQT lapujadeo@who.int
More informationQuality Assurance Policy. for the. Procurement of HIV Point-of-Care Technology. under the UNITAID Grant
Quality Assurance Policy for the Procurement of HIV Point-of-Care Technology under the UNITAID Grant UNICEF Supply Division Quality Assurance Centre and Health Technology Centre Revisions Version Date
More informationTuberculosis. Ruth McNerney
Tuberculosis African and interregional harmonization activities to improve access to affordable IVD Ruth McNerney London School of Hygiene & Tropical Medicine Department of Pathogen Molecular Biology,
More informationWHO/PQT Updates on WHO Prequalification Priorities and Regulatory Systems Strengthening work
WHO/PQT Updates on WHO Prequalification Priorities and Regulatory Systems Strengthening work Dr Drew Meek Prequalification Team Regulation of Medicines and other Health Technologies Essential Medicines
More informationANNEX 8: Ensuring the quality of HIV testing services
ANNEX 8: Ensuring the quality of HIV testing services Acknowledgement: Sands, A 1 8.1 WHO Prequalification of In Vitro Diagnostics Programme The WHO Prequalification of in Vitro Diagnostics Programme is
More informationVision and strategies to Increase Access to Innovative HIV Diagnostic Technologies. Willy Urassa. AMD STAKE HOLDERS MEETING 7-8 May 2013
Vision and strategies to Increase Access to Innovative HIV Diagnostic Technologies Willy Urassa 1 Outline Definition Introduction Vision Broad strategies Progress so far Recent experience 2 Expansion of
More informationProcurement policies and requirements
Procurement policies and requirements JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 22-24 Sep 2014 ELODIE JAMBERT International Pharmacist Coordinator Médecins Sans Frontières (MSF)
More informationGlobal Fund Quality Assurance Policy for Diagnostics products : collaboration with WHO DLT
Global Fund Quality Assurance Policy for Diagnostics products : collaboration with WHO DLT Pharmaceutical Management Unit Quality Assurance and Data Management Team QA for health products financed by Global
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 96) Number: PQDx 0200-046-00 Abstract COBAS AmpliPrep/COBAS
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: Alere HIV Combo WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: Alere HIV Combo WHO reference number: PQDx 0243-013-00 Alere HIV Combo with product codes 7D2842, 7D2843, 7D2843SET manufactured by Alere
More informationIntroduction to PAHWP-EAC-LSHTM Workshop on Assessment of Clinical Performance of in-vitro Diagnostics
Introduction to PAHWP-EAC-LSHTM Workshop on Assessment of Clinical Performance of in-vitro Diagnostics Rosanna W Peeling Professor and Chair, Diagnostic Research Director, International Diagnostics Centre
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Alere Determine HIV-1/2 Number: PQDx Abstract
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Alere Determine HIV-1/2 Number: PQDx 0033-013-00 Abstract The Alere Determine HIV-1/2 with product codes 1 7D2342, 7D2343 and 7D2243
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx 0159-055-00 OraQuick HIV 1/2 Rapid Antibody Test with product codes 5x4-0010
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx 0159-055-00 OraQuick HIV 1/2 Rapid Antibody Test with product codes 5x4-0010
More informationConsolidated Donor Funded Procurement of HIV Diagnostics
Consolidated Donor Funded Procurement of HIV Diagnostics Meeting on HIV Diagnostic Global Demand Forecast Geneva, 9 April 2015 Mercedes Perez Gonzalez Prequalification Team Diagnostics Assessment Department
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: INSTI HIV-1/HIV-2 Antibody Test Number: PQDx
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: INSTI HIV-1/HIV-2 Antibody Test Number: PQDx 0002-002-00 Abstract INSTI HIV-1/HIV-2 Antibody Test with product codes, 90-1013, 90-1010,
More information4. Considerations for streamlining the prequalification procedure on the basis of enhanced assistance by NRAs 328
Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies Abbreviations 317 1. Introduction 317 2. Conditions for acceptance of applications 319 3. Steps
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: SD BIOLINE HCV WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: SD BIOLINE HCV WHO reference number: PQDx 0257-012-00 SD BIOLINE HCV with product code 02FK10, manufactured by Standard Diagnostics,
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Uni-Gold HIV Number: PQDx Abstract
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Uni-Gold HIV Number: PQDx 0149-052-00 Abstract Uni-Gold HIV with product codes 1206502, 1206502N, 1206502E, 1206502N-100 manufactured
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) Number: PQDx 0221-046-00 Abstract COBAS AmpliPrep/COBAS
More informationVaccines: (inter)national regulation and quality in resource limited settings
Vaccines: (inter)national regulation and quality in resource limited settings Raffaella Ravinetto QUAMED Research & Networking Institute of Tropical Medicine Antwerp 12th July 2017 Based on a presentation
More informationISO 13485:2016 MEDICAL DEVICES QMS TRANSITION GUIDE
ISO 13485:2016 MEDICAL DEVICES QMS TRANSITION GUIDE ISO 13485, OVERVIEW ISO 13485 sets regulatory requirements or, when specified, customer requirements for a management system for medical devices or services.
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: OraQuick HCV Rapid Antibody Test Kit WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: OraQuick HCV Rapid Antibody Test Kit WHO reference number: PQDx 0244-055-00 OraQuick HCV Rapid Antibody Test Kit with product codes 1001-0270
More informationExpedited procedure for evaluating pandemic influenza A (H1N1) 2009 vaccines
Expedited procedure for evaluating pandemic influenza A (H1N1) 2009 vaccines Preamble On 11 June 2009, WHO declared an influenza pandemic caused by influenza A (H1N1) 2009 virus 1. On 13 July 2009, WHO
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Uni-Gold HIV Number: PQDx Abstract
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Uni-Gold HIV Number: PQDx 0149-052-00 Abstract Uni-Gold HIV with product codes 1206502, 1206502N, 1206502E, 1206502N-100 manufactured
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: First Response HIV Card Test Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: First Response HIV 1-2-0 Card Test Number: PQDx 0018-010-00 Abstract First Response HIV 1-2-0 Card Test with product codes
More informationProcedure for the expedited review of imported prequalified vaccines with view to granting a marketing authorization
Procedure for the expedited review of imported prequalified vaccines with view to granting a marketing authorization Prequalification Stakeholders Meeting Geneva, CICG 4 and 5 April 2011 Dr. Nora Dellepiane
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx 0145-027-00 Abstract Abbott RealTime HIV-1 (m2000sp) assay with product code 2G31, which
More informationAn Introduction to Access to Diagnostics. 14:00-14:45 BST 17 June
An Introduction to Access to Diagnostics 14:00-14:45 BST 17 June Chair: Dr Greg Martin, Specialist Registrar, Public Health Medicine and Editor-in- Chief of Globalization and Health @drgregmartin Speakers:
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: HIV 1/2 STAT-PAK Number: PQDx Abstract
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: HIV 1/2 STAT-PAK Number: PQDx 0007-006-00 Abstract The HIV 1/2 STAT-PAK with product code HIV101, manufactured by Chembio Diagnostic
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: SURE CHECK HIV 1/2 Assay Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: SURE CHECK HIV 1/2 Assay Number: PQDx 0054-006-00 Abstract SURE CHECK HIV 1/2 Assay with product code HIV201, manufactured
More informationPOINT OF CARE DIAGNOSTICS
ENSURING ACCESS TO POINT OF CARE DIAGNOSTICS IN DECENTRALISED HIV AIDS PROGRAMMES REQUEST FOR EXPRESSION OF INTEREST Technology : Point of Care HIV diagnostic and treatment monitoring devices for Early
More informationa practical guide ISO 13485:2016 Medical devices Advice from ISO/TC 210
a practical guide ISO 13485:2016 Medical devices Advice from ISO/TC 210 for SMEs a practical guide ISO 13485:2016 Medical devices Advice from ISO/TC 210 Copyright protected document All rights reserved.
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: OraQuick HIV Self-Test WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: OraQuick HIV Self-Test WHO reference number: PQDx 0159-055-01 OraQuick HIV Self-Test with product codes 5X4-1000 and 5X4-1001 manufactured
More informationProcedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies
Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies World Health Organization 2010 All rights reserved. Publications of the World Health Organization
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Murex HIV Ag/Ab Combination Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Murex HIV Ag/Ab Combination Number: PQDx 0144-043-00 Abstract Murex HIV Ag/Ab Combination with product codes 7G79-09 (GE41,
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Alere HIV/Syphilis Duo Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Alere HIV/Syphilis Duo Number: PQDx 0179-012-00 Abstract Alere HIV/Syphilis Duo with product codes 06FK30 and 06FK35, manufactured
More informationIndustry s Perspective on the Status of Medical Device Regulations. FUNDISA Workshop 09 & 10 Oct Anele Vutha SAMED Regulatory Committee
Industry s Perspective on the Status of Medical Device Regulations FUNDISA Workshop 09 & 10 Oct 2014 Anele Vutha SAMED Regulatory Committee Today s Topics: 1. Medical Device Definition - Differences 2.
More informationREGIONAL ALLIANCE FOR NATIONAL REGULATORY AUTHORITIES FOR VACCINES IN THE WESTERN PACIFIC. second edition
REGIONAL ALLIANCE FOR NATIONAL REGULATORY AUTHORITIES FOR VACCINES IN THE WESTERN PACIFIC second edition World Health Organization 2014 The designations employed and the presentation of the material in
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device Number: PQDx 0141-051-00 Abstract ABON HIV 1/2/O Tri-Line Human
More information2019 HIV DIAGNOSTICS CONFERENCE
2019 DIAGNOSTICS CONFERENCE Optimizing Testing for, STIs and in Laboratories, Public Health Programs and Clinical Practice Abstract and Discussion Panel Proposal Submission Dates Please submit your abstracts/discussion
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: Alere q HIV-1/2 Detect WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: Alere q HIV-1/2 Detect WHO reference number: PQDx 0226-032-00 Alere q HIV-1/2 Detect with product codes 270110050, 270110010 and 270300001,
More informationGAVI s Financing for Pneumococcal Vaccines, including the Advance Market Commitment
GAVI s Financing for Pneumococcal Vaccines, including the Advance Market Commitment Tania Cernuschi Third Regional Pneumococcal Symposium, Istanbul, 13th - 14th February 2008 1 The GAVI Alliance Public-private
More informationHIV Testing and Systems for Managing HIV Implementation in Resource Limited Settings
HIV Testing and Systems for Managing HIV Implementation in Resource Limited Settings Elizabeth M. Dax with the staff of the National Serology Reference Laboratory, Australia My Background Worked in HIV
More information2008 Public Status Report on the Implementation of the European Risk Management Strategy. Executive Summary
European Medicines Agency London, 17 March 2009 Doc. Ref. EMEA/43556/2009 2008 Status Report on the Implementation of the European Risk Management Strategy Executive Summary The European Risk Management
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: DPP HIV 1/2 Assay WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: DPP HIV 1/2 Assay WHO reference number: PQDx 0053-006-00 DPP HIV 1/2 Assay with product code 65-9506-0, manufactured by Chembio Diagnostic
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Murex HBsAg Version 3 with Murex HBsAg Confirmatory Version 3 Number: PQDx 0121-043-00 Abstract Murex HBsAg Version 3 with Murex HBsAg
More informationWHO Emergency Use Assessment and Listing (EUAL) Procedure. Robyn Meurant WHO PQ Team Diagnostics Assessment
WHO Emergency Use Assessment and Listing (EUAL) Procedure Robyn Meurant WHO PQ Team Diagnostics Assessment 1 Aim of WHO Prequalification: Diagnostics Assessment To promote and facilitate access to safe
More informationUNITAID investments to innovate and scale up access to HIV diagnostics
UNITAID investments to innovate and scale up access to HIV diagnostics WHO Annual meeting with Diagnostic Manufacturers and Stakeholders 10 March 2016 Smiljka de Lussigny (HIV Diagnostics Programme Manager,
More informationTechnical Guidance Series (TGS) for WHO Prequalification Diagnostic Assessment
Technical Guidance Series (TGS) for WHO Prequalification Diagnostic Assessment Panels for quality assurance and quality control of in vitro diagnostic medical devices WHO/EMP/RHT/PQT/2017.10 World Health
More informationTarget Product Profile and Technical Requirements for Conjugated Pneumococcal Vaccines. AMC Pre-tender meeting. Copenhagen 10 March 2011
Target Product Profile and Technical Requirements for Conjugated Pneumococcal Vaccines 1 Target Product Profile for AMC support The specifications relate to the public health impact and suitability of
More informationAustralian Jurisdictional Update September 2018
Australian Jurisdictional Update September 2018 Dr Elizabeth McGrath Strategic Adviser Medical Devices and Product Quality Division Department of Health Overview The Australian Government s Expert Review
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 21 September 2006 EMEA/CHMP/BWP/298390/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON
More informationThe new WHO global injection safety policy and campaign
The new WHO global injection safety policy and campaign B. Allegranzi, SDS, HIS WHO/USAID/PEPFAR hosted webinar 20 August 2015 Overuse of injections and unsafe injection practices worldwide in 2000 (1)
More informationExcipient Risk Assessment
Excipient Risk Assessment Richard O Sullivan- GMP Inspector GMP Conference 7 February 2017 Dublin Content Background 1 Guidance 2 HPRA Expectations 3 07/02/2017 2 Excipient Risk Assessment-Why? 07/02/2017
More informationQuality Management System Certification. Understanding Quality Management System (QMS) certification
Quality Management System Certification Understanding Quality Management System (QMS) certification The medical device manufacturing sector is one of the most regulated sectors in which significant quality
More informationInnovation, Access and Use Department of Essential Medicines and Health Products WHO
MARKETS FOR QUALITY-ASSURED PRODUCTS Sarah Garner and Francisco Blanco Innovation, Access and Use Department of Essential Medicines and Health Products WHO 1 Objectives Indicate market needs for medicines
More informationQuality assurance for essential medicines and health products: moving towards an harmonized approach
Quality assurance for essential medicines and health products: moving towards an harmonized approach Prequalification of vaccines David Wood QSS/EMP/WHO 12 December 2012 A growing portion of vaccines procured
More informationGlobal strategy on viral hepatitis and regional action plan: monitoring framework and 10 core indicators
Global strategy on viral hepatitis and regional action plan: monitoring framework and 10 core indicators Antons Mozalevskis WHO Regional Office for Europe EMCDDA DRID National Expert Meeting Lisbon, 6
More informationSupporting Countries to Expand HIV Diagnostics
Supporting Countries to Expand HIV Diagnostics Diagnosis through Monitoring HIV Diagnostics Manufacturers Engagement 18 September 2014 Objectives for the day 1.Provide an update on our Quality Assurance
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Enzygnost HIV Integral 4 WHO reference number: PQDx
PQDx 0214-064-00 WHO PQDx PR April/2016, version 3.0 WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Enzygnost HIV Integral 4 WHO reference number: PQDx 0214-064-00 Enzygnost
More informationProgramme update. Prequalification of Vaccines
Programme update Prequalification of Vaccines UN Prequalification of Medicines, Diagnostics and Vaccines 6th Consultative Stakeholder Meeting 4 April 2011 David Wood, WHO/IVB/QSS Outline Good news - A
More informationTesting for G6PD deficiency for safe use of primaquine in radical cure of P. vivax and P. ovale
Testing for G6PD deficiency for safe use of primaquine in radical cure of P. vivax and P. ovale Webinar presentation to support the dissemination of the policy brief Silvia Schwarte, WHO/GMP e-mail: schwartes@who.int
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48) Number: PQDx 0126-046-00 Abstract The COBAS AmpliPrep/COBAS TaqMan
More information2014/LSIF/PD/025 Malaysia s Approach to Testing Strategies
2014/LSIF/PD/025 Malaysia s Approach to Testing Strategies Submitted by: Malaysia Policy Dialogue and Workshop on Attaining a Safe and Sustainable Blood Supply Chain Manila, Philippines 30 September 1
More informationOverview of the PAHO strategy and activities to strengthen National Regulatory Authorities in the Americas
Overview of the PAHO strategy and activities to strengthen National Regulatory Authorities in the Americas Ma. de los Angeles Cortes Regional Advisor on Vaccines and Biologicals HSS/MT Annecy, France March
More informationWHO Guidelines on hepatitis B and C testing
WHO Guidelines on hepatitis B and C testing Dr. Philippa Easterbrook Global Hepatitis Programme World Hepatitis Summit Nov 2017 Sao Paulo, Brazil Outline of presentation Key recommendations of 2017 WHO
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Bioelisa HIV 1+2 Ag/Ab Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Bioelisa HIV 1+2 Ag/Ab Number: PQDx 0183-060-00 Abstract Bioelisa HIV 1+2 Ag/Ab with product codes 3000-1172 and 300-1173,
More informationCollaborative procedure for licensing Prequalified vaccines
Collaborative procedure for licensing Prequalified vaccines DCVMN meeting Shanghai, China March 2015 World Health Organization, EMP/RHT/PQT rodriguezhernandezc@who.int meekd@who.int Strategic priorities
More informationVaccine standardization in the context of PQ. Dr Ivana Knezevic Quality, Safety and Standards WHO, Geneva
Vaccine standardization in the context of PQ Dr Ivana Knezevic Quality, Safety and Standards WHO, Geneva Outline WHO standards for vaccines Vaccines of assured quality Written and measurement standards
More information4.6. How to test - testing strategy HCV. Decision-making tables PICO 4
4.6. How to test - testing strategy HCV Decision-making tables PICO 4 Testing strategy to ascertain exposure to HCV: Among persons identified for hepatitis C testing, what is the best testing strategy
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Bioelisa HCV 4.0 Number: PQDx Abstract
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Bioelisa HCV 4.0 Number: PQDx 0165-060-00 Abstract Bioelisa HCV 4.0 with product codes 3000-1115 and 3000-1116, manufactured by Biokit
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx 0145-027-00 Abstract The Abbott RealTime HIV-1 (m2000sp) assay with product code 2G31 (which
More informationSoftware as a Medical Device (SaMD)
Software as a Medical Device (SaMD) Clinical Evaluation IMDRF/SaMD WG (WD2)/N41R1: 2016 Bakul Patel, USA FDA Chair SaMD Working Group Scope NWIE Proposal - Software as a Medical Device (SaMD): Clinical
More informationGavi Secretariat Update: Progress, priorities and strategies
Gavi Secretariat Update: Progress, priorities and strategies Melissa Malhame UNICEF Vaccine Manufacturer Consultation Copenhagen 8-9 October 2014 www.gavi.org Gavi s impact 2000-2013 2 New vaccines now
More informationDiagnostics RDT / POC Technology for ZIKA related infections
Diagnostics RDT / POC Technology for ZIKA related infections Outline Overview of afternoon agenda Background Product Landscape analysis ZIKA scenarios of demand, areas of focus Lessons learnt.. ZIKA diagnostic
More informationProcurement Strategy for Rotavirus and Pneumococcal Conjugate Vaccines. Supplier meeting UNICEF Supply Division 3-4 April 2008 Ann Ottosen
Procurement Strategy for Rotavirus and Pneumococcal Conjugate Vaccines Supplier meeting Supply Division 3-4 April 2008 Ann Ottosen Strategic decisions leading to procurement of Rotavirus and Pneumococcal
More informationDiagnostics product development projects
Page 0 Diagnostics product development projects Smiljka de Lussigny Technical Officer, HIV UNITAID Copenhagen, 23 September 2013 Page 1 1 2 3 About UNITAID HIV diagnostics market UNITAID s current investment
More informationUNITAID. Dr Philippe Duneton Deputy Executive Director Copenhagen September 2012
UNITAID Dr Philippe Duneton Deputy Executive Director Copenhagen September 2012 Challenges Achievements WHO Prequalification UNITAID support for prequalification of medicines Since 2007 UNITAID support
More informationa practical guide Medical Devices Advice from ISO/TC 210 This is a free 11 page sample. Access the full version online.
NSAI/ISO Guide to ISO 13485:2016 Medical Devices a practical guide Advice from ISO/TC 210 NSAI/ISO Guide to ISO 13485:2016 This Guide is the NSAI adoption of and is technically identical to the English
More informationTreatment and Access to Drugs
Treatment and Access to Drugs Presenter: Co-leads: Peter Beyer & Philippa Easterbrook WHO Regional Advisor for South East Asia (SEARO): Razia Narayan Pendse Session Objectives By the end of this session,
More informationFifth report of Committee A
SIXTY-EIGHTH WORLD HEALTH ASSEMBLY (Draft) A68/73 26 May 2015 Fifth report of Committee A (Draft) Committee A held its twelfth and thirteenth meetings on 25 May 2015 under the chairmanship of Dr Eduardo
More informationIl ruolo delle VEQ per la sicurezza trasfusionale
Il ruolo delle VEQ per la sicurezza trasfusionale The role of EQA for transfusion safety Giulio Pisani CNCF Ist. Sup. Sanità Global Blood Product Safety, Roma 10 aprile 2019 Blood transfusion is an essential
More informationto be notified: all parties involved in the graduated plan procedure. Annexes
Paul-Ehrlich-Institut Postfach 63207 Langen, Germany To all marketing authorisation holders of cellular blood preparations and therapeutic single plasmas as well as authorisation holders of stem cells
More informationFrom Vaccine Development to Policy: A Brief Review of WHO Vaccine-Related Activities and Advisory Processes (2017)
1. Introduction From Vaccine Development to Policy: A Brief Review of WHO Vaccine-Related Activities and Advisory Processes (2017) To help achieve the implementation of the Global Vaccine Action Plan (GVAP),
More informationIncreasing Quality-Assured HIV Diagnostics Internationally (15 minutes)
WHO MEETING WITH DIAGNOSTIC MANUFACTURERS AND STAKEHOLDERS GLOBAL FORECASTS OF DIAGNOSTIC DEMAND FOR 2014-2018 WHO Headquarters, Main WHO Building Salle D Geneva, Switzerland Thursday 9 April and Friday
More informationFDA Regulation of Diagnostic Tests Jeffrey N. Gibbs Hyman, Phelps & McNamara, P.C. Washington, DC
AIPLA Annual Meeting Joint Biotechnology Committee/ Special Committee on FDA Law Program October 21, 2010 Marriott Wardman Park Hotel Washington, DC FDA Regulation of Diagnostic Tests Jeffrey N. Gibbs
More informationOverhauling The 510(k) Process
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Overhauling The 510(k) Process Law360, New York (August
More informationStandardization for Preclinical Evaluation of Influenza Vaccines in Animal Models - WHO activities
Standardization for Preclinical Evaluation of Influenza Vaccines in Animal Models - WHO activities 2 nd WHO Integrated Meeting on development and clinical trials of Influenza vaccines that induce broadly
More informationRapid Diagnostics CHAI Experience. 6 th Moving Forward in Diagnostics Forum Les Pensieres November 7, 2012
Rapid Diagnostics CHAI Experience 6 th Moving Forward in Diagnostics Forum Les Pensieres November 7, 2012 CHAI is working in 12 countries on HIV POC test implementation Kenya Tanzania Ethiopia Malawi Mozambique
More informationNHS public health functions agreement Service specification No.32 Human papillomavirus immunisation programme for men who have sex with men
NHS public health functions agreement 2018-19 Service specification No.32 Human papillomavirus immunisation programme for men who have sex with men (HPV-MSM) 1 NHS public health functions agreement 2018-19
More informationThe New Regulations - Special IVD Issues
The New Regulations - Special IVD Issues Dirk Stynen, Ph. D. President - Principal Consultant Qarad Geel, Belgium RMD Brussels October 2018 The IVD Regulation 2017/746 October 29, 2018 www.qarad.com 2
More informationVaccine Production and Regulation
Vaccine Production and Regulation Dr Houda LANGAR Essential Vaccines and Biologicals Policy Department of Health Systems & Services Development Capacity Development Workshop on Health System Development
More informationGOOD REGULATORY REVIEW PRACTICES WORKING GROUP UPDATE. Working Group Chair: Melissa Torres US Food and Drug Administration
GOOD REGULATORY REVIEW PRACTICES WORKING GROUP UPDATE Working Group Chair: Melissa Torres US Food and Drug Administration GOALS The Good Regulatory Review Practices working group has focused efforts on
More informationInvitation for Proposals
Invitation for Proposals UNFPA, the United Nations Population Fund, an international development agency, invites qualified organizations to submit proposals for the implementation of an initiative to strengthen
More informationAdvancing Treatment 2.0: Progress on the 2013 Consolidated Guidelines What s new
Advancing Treatment 2.0: Progress on the 2013 Consolidated Guidelines What s new H I V / A I D S D e p a r t m e n t WHO HQ Meg Doherty, MD, MPH, PhD Coordinator Treatment and Care November 5, 2012 1 Overview
More information