!!!!!!!! !!!!!!!!!!!!! Submitted!by:!!Nancy!Abbey! Executive!Director! MEDEC!!Reuse!of!SingleAUse!Devices!Task!Force!!!! June!4,!2014!
|
|
- Beryl Day
- 6 years ago
- Views:
Transcription
1 BillC&17:ImprovingPatientSafetyby RegulatingReprocessedSingle&UseMedical Devices SubmissiontotheHouseofCommons StandingCommitteeonHealth Submittedby:NancyAbbey ExecutiveDirector MEDEC ReuseofSingleAUseDevicesTaskForce June4,2014
2 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth MEDEC is the national association representing the medical technology industry in Canada. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and helpenablethesustainabilityofourpublicallyfundedhealthcaresystem. The medical technology industry in Canada employs over 35,000 Canadians in approximately 1,500 facilities, and has sales of over $7 billion per annum. We are committed to supporting the growth of a strong and vibrant medical technology industrythatcontributestocanada sinnovationeconomy. June4,2014Page1of7
3 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth MEDECispleasedtopresentthisbrieftotheHouseofCommonsStandingCommittee on Health for consideration as part of its review for Bill CA17 An Act to amend the FoodandDrugsAct. MEDEC member companies are fully supportive of Bill CA17 to amend the Food and Drugs Act in order to improve patient safety by introducing measures that will strengthensafetyoversightandimprovereportingofseriousadverseevents. It is important to MEDEC members that patients and health care providers have confidenceinthesafetyofourhealthcaresystem.weallbenefitwhenpublictrustis atitshighest.thisisacrucialcomponenttotheabilityofinnovatorstobringbetter, new medical innovations into the system which ultimately enable better health outcomes and health care system sustainability. Something we all work together to strive for every day. Bill CA17 helps to build that public trust and grow Canadians confidenceinourhealthcaresystem. Wehaveanopportunitytoworktogethertofurtherstrengthenthislegislation.Afull listofmedecrecommendationsforbillca17isavailableinappendix1. WerecognizethatBillCA17 is intended to address a number of concerns specific to drugs,howeverthereisalongastandingmedicaldeviceissuethatwarrantsparticular attentionbythecommitteeforamendmentsandformsthebasisforthissubmission. ThisissueisregardingthereuseandreprocessingofsingleAusemedicaldevicesand thefactthatthereisnotanyfederalregulatoryoversightregardingthispracticeraises concernsforpatientsafetyandquestionsregardinglegalliability. June4,2014Page2of7
4 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth ReuseofSingle&UseMedicalDevices&ConcernforPatientSafety Inanefforttosavemoneyandreducemedicalwaste,hospitalsinCanadaarereusing medicaldevicesthatarelicensedbyhealthcanadatobeusedonlyonceoronasingle patientduringasingleprocedureandthenbediscarded. This practice is widespread. The Canadian Agency for Drugs and Technologies in Health (CADTH) reported in 2008 that 28% of hospitals in Canada and 42% of hospitalswithover250bedswerereprocessingsingleausedevices(suds)eitherina houseorbyathirdapartyreprocessor. i Among the devices being reused are electrophysiology catheters used to diagnose heartarrhythmias,harmonicscalpelsusedduringsurgerytocutandsealtissue,and burrsandbladesusedduringanorthopeadicprocedure. SingleAuse devices are not designed or licensed to be disassembled, cleaned, reassembled and reused, and doing so can jeopardize their performance, safety, and effectiveness. ii AdvisoryletterssentfromHealthCanadain2005and2007tohospitaladministrators andotherstakeholdersexpressedconcernthatthereuseofsingleausedevicesmaybe hazardoustopatients. FederalSituation NoRegulationsDespiteRepeatedCallsforAction It has been over ten years since the Auditor General of Canada recommended in March 2004 that Health Canada take action, such as regulating the reprocessing of singleausedevices,tomanagethehealthandsafetyrisksrelatedtothereuseofsinglea usemedicaldevices. iii June4,2014Page3of7
5 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth TherehavebeenrepeatedcallsfromtheHealthCanadaScientificAdvisoryPanelon Reprocessing of Medical Devices iv andthecanadian Orthopeadic Association v for HealthCanadatoregulatethereuseandreprocessingofsingleAusedevices. Health Canada has concluded that the Food and DrugsAct, from which the Medical Device Regulations derive their authority, is not intended to apply to the use of a deviceafteritssalethereforehealthcanadadoesn thavetheauthoritytoregulatethe reprocessing of singleause devices by hospitals or thirdaparty reprocessing companies vi AtthetimethatHealthCanadareviewedtheirregulatoryauthority,thevastmajority ofreprocessingwasbeingdonebyinahousehospitalstaff.thesituationhasevolved now with most hospitals outsourcing this activity and signing contracts with thirda partyreprocessingcompanies.therearenothirdapartyreprocessingcompaniesfor singleausedevicesbasedincanada. HealthCanadahaspubliclyacknowledgedthatbusinessmodelsforreprocessinghave changedovertime vii andthatatleastonereprocessorissellingreprocessedsingleause devicestocanadianhospitals. viii Health Canada has been unable to take action given the current Food and Drugs Act andmedicaldeviceregulations. HospitalsacrossthecountryareshippinguseddeviceslicensedforsingleAusetoU.S. based companies for reprocessing without any federal regulatory oversight for the devicesthatarethenbeingshippedbackforuseincanadianhospitals. PatientSafety WhyAmendmentsareImportant In Canada, original equipment manufacturers must present substantive scientific evidence of a device s safety, effectiveness and quality as required by the Food and June4,2014Page4of7
6 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth DrugsActand Medical Device Regulations, prior to being given authorization to sell andmarketadeviceincanada.therearealsospecificrequirementsfordocumenting andreportingadverseeventswithclearguidanceonhowtoissuearecallshouldthe situationwarrantsuchaction. Currently, thirdaparty reprocessing companies are not required to comply with Canada s Medical Device Regulations, raising important concerns regarding Health Canada sroleinensuringpatientsafety. 1. Device Licensing: Health Canada does not require thirdaparty reprocessing companiestosubmitsafety,effectivenessorqualitydataforthedevicestheyare sellingand/orshippingbackforuseincanadianhospitals. 2. Adverse Event Reporting: The Medical Device Regulations, specific to adverse eventreporting,currentlydonotapplytothirdapartyreprocessors.forinstance, thirdaparty reprocessing companies are not required to maintain records of reported problems related to a device nor are they required to report adverse eventstohealthcanada. 3. Device Recalls: Unlike original equipment manufacturers regulated by Health Canada, thirdaparty reprocessing companies are not required to provide a proposed strategy to the Health Minister as to how a device recall would be conductedandaproposedplantopreventarecurrenceoftheproblem. BillC&17Amendments&ToRegulateReprocessedSingle&UseDevices AmendmentstoBillCA17provideanopportunityforHealthCanadatobegrantedthe authoritytoregulatereprocessedsingleausedevices. June4,2014Page5of7
7 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth It is our recommendation that Health Canada regulate thirdaparty reprocessing companiesasmanufacturersinthecontextofcanada smedicaldeviceregulationsas hasbeenthecaseinothercountriesincludingtheunitedstates. ThedefinitionofamanufactureraccordingtoCanada smedicaldeviceregulationsis thefollowing: A person who sells a medical device under their own name, or under a trademark,design,tradenameorothernameormarkownedorcontrolledby the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or assigningitapurpose,whetherthosetasksareperformedbythatpersonoron theirbehalf. We are recommending amendments be made to Section 30 of the Act, as this is the section addressing regulationamaking authority for therapeutic products (including medicaldevices). Recommendation#1 Modify the regulationamaking power in section 30 (1.2)(a) to include reprocessingasalistedactivityinrespectofwhichauthorizationsmaybeissued, asfollows: Respectingtheissuanceofauthorizations=includinglicenses=thatauthorize,as the case may be, the import, sale, advertisement, manufacture, reprocessing, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product, and the amendment, suspension and revocation of such authorizations Recommendation#2 AddasubAsectiontosection30(1.2)providingfortheauthoritytomakeregulations requiring that reprocessors of devices licensed for singleause obtain therapeutic productauthorizationsinrespectofthosereprocesseddevices. June4,2014Page6of7
8 MEDECBrief(BillCA17):HouseofCommonsStandingCommitteeonHealth StrengtheningBillC&17 BenefitsfromAmendments ThebenefitofmakingtheseamendmentstoBillC=17tostrengthenpatientsafety wouldbe: Clarity regarding evidence clear, appropriate requirements for evidence to demonstratethatdeviceswillperformasintendedandaresafeforpatientswhen usedbyatrainedhealthcareprofessional. Greater transparency and traceability A to ensure that patients, doctors, industry and other stakeholders have access to clear information about the medicaldevicestheyuse. Enhanced vigilance and market surveillance to allow for a rapid identificationofadverseeventsandtoensurecoherentandtimelyaction. In conclusion,medecwants to reiterate itssupportforbillca17. We believe that these amendments can address a longastanding issue and enhance this important pieceoflegislationtoimprovepatientsafety. i HaileyD,JacobsP,RiesN,PolisenaJ,NormandinS,NooraniH,LaffertyS,GardamM.Reprocessingof single=usemedicaldevices:nationalsurveyofcanadianacute=carehospitals.(technologyreportnumber 104).Ottawa:CanadianAgencyforDrugsandTechnologiesinHealth(CADTH);2008 iimorrison,aanddowler,j.reprocessingofsingle=usemedicaldevices:a2011update(environmental Scanissue28).Ottawa:CanadianAgencyforDrugsandTechnologiesinHealth;2011. iiireportoftheauditorgeneralofcanada.chapter2:healthcanada=regulationofmedicaldevices March2004. ivhealthcanadasaparmdmeeting.panelrecommendations.feb2005 vcanadianorthopeadicassociation.reuseofsingle=usedevicespositionpaper.sept2011.available fromhttp:// vihealthcanada.lettertohospitaladministrators.updateonreprocessingandreuseofsingle=use MedicalDevices.October17,2007 viid.boyer,medicaldevicesbureau.futuredirectionofreprocessingsingle=usemedicaldevices.may viiip.neufeld,medicaldevicesbureau.regulatorystatusofreprocessingsingle=usedevices.nov2010 June4,2014Page7of7
9 Appendix(1( ( MEDEC(Recommendations(( Bill(C717( (An(Act(to(amend(the(Food(and(Drugs(Act( June(4,(2014( ( Suggested(amendments(to(regulate(reprocessed(single7use(devices( 1. Section 30 (1.2) (a) should be modified to include reprocessing as a listed activity in respectofwhichauthorizationsmaybeissued,asfollows: Respectingtheissuanceofauthorizations2includinglicenses2thatauthorize,asthecase may be, the import, sale, advertisement, manufacture, reprocessing, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product, and the amendment,suspensionandrevocationofsuchauthorizations 2. AddasubCsectiontosection30(1.2)providingfortheauthoritytomakeregulations requiring that reprocessors of devices licensed for singlecuse obtain therapeutic productauthorizationsinrespectofthosereprocesseddevices. ( Suggested(amendments(to(further(strength(Bill(C717( 3. BillC217lacksadefinitionfortheterm medicaldeviceincident usedforexamplein section5,21.8.wesuggesteitherusingtheterm prescribedmedicaldeviceincident, which would leave to a later regulation amendment which incidents are to be reported, or to add a definition that ensures that the Bill and its future regulations would follow the language or terminology currently used in the Canadian Guidance Document for Mandatory Problem Reporting for Medical Devices, January 14, 2011, whichisinternationallyalignedbasedonworkoftheghtf(nowimdrf). Other Health Canada documents (e.g. Medical Device Problem Reporting by Health CareFacilities,MedicalProfessionalsandotherdeviceusers)define incident broadly as anyconcernsthatrelatetothesafety,effectivenessorqualityofamedicaldevice that have been detected during use or identified during device examination and testing prior to use. The problems include deficiencies in the design of the device, defectsarisingfromthemanufacturingandinadequacyorerrorsinlabelingsuchas directionsforuse. The industry would need clarity regarding the applicable definition also under the aspect that section 5, 21.8 is about serious adverse drug reactions and a medical deviceincident,whichdoesnotsoundbalancedandcouldleadtotheimpressionthat theterm medicaldeviceincident isusedinthebroadersense.ifitwerethecase,this wouldnotfindagreementbytheindustry.
10 MEDEC Brief (Bill C-17): House of Commons Standing Committee on Health June 4, The powers of the Minister in section 3, 21.1, 21.2, 21.3(1), and 21.3 (2) should enable action that is evidence based and be in line with other relevant Canadian legislation.inordertoclarifythismedecrequeststhattheseclausesopenwith Ifthe Ministerbelievesonreasonablegrounds,languagewhichisconsistentwithcurrent CMDRsandalsousedintheCanadaConsumerProductsSafetyAct. 5. ThepowersoftheMinisterinsection3,21.2,21.3,21.31,and21.32(b)willlimitthe authority given to the licence holder in the licensing process during application review.medecrequeststhattheseclausesbeamendedby Priortoissuingsuchorder the Minister shall provide the holder of a therapeutic product authorization the opportunitytobeheard. In case the request relates to regulations related to these powers it should be considered in the drafting process in order to provide a balanced framework that containsareasonableapproachtowardsdisputeresolution. 6. Section3,21.3(1)(b)shouldbemodifiedto holdtheproductinquarantine,orsend theproductorcauseittobesent,toaplacespecifiedintheorder. The nature of certain medical devices may require to rather holding them in quarantineattheircurrentlocationasshipmentanddetentioncouldcompromisethe qualityandintegrityofthedevice. 7. Section3,21.3(3)shouldbemodifiedto ordersthem,oranotherperson,towithdraw fromthemarket. The definition of a recall in Canada for medical devices is very broad and includes a varietyofcorrectiveactions dependingontheincidence,situation,andtypeofdevice andastopsalewouldprobablynotbeappropriateforallthese recall situations.italso needstobeclearthata correctiveaction provideditmitigatestherisk removesthe reasonfortheordertostopselling. Appendix1:Page2of2
Reuse of SUDs: Using Evidence to Inform Policy
Reuse of SUDs: Using Evidence to Inform Policy Implications for Health Policy Philip D. Neufeld Medical Devices Bureau Health Canada CADTH Symposium Edmonton, AB, April 28, 2008 NEW EVIDENCE TO INFORM
More informationNew EU legislation on Medical Devices. Erik Hansson Deputy Head of Unit European Commission DG Health and Consumers 1
New EU legislation on Medical Devices Erik Hansson Deputy Head of Unit European Commission DG Health and Consumers 1 Drivers for change Presentation Commission proposals State of play in negotiations What
More informationUnderstanding the Pharmacy and Drug Act amendments and mail order pharmacy licensing
Understanding the Pharmacy and Drug Act amendments and mail order pharmacy licensing Background As reported in the Spring 2009 issue of acpnews, ACP and Alberta Health and Wellness developed a new policy
More informationGuide to Incident Reporting for In-vitro Diagnostic Medical Devices
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices SUR-G0004-4 02 AUGUST 2012 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes
More informationRe-use of Single Use Devices Implications for Hospitals
Re-use of Single Use Devices Implications for Hospitals April 28, 2008 Sudha Kutty, Director, Patient Safety and Clinical Best Practice Ontario Hospital Association Agenda About OHA Current Drivers against
More informationContains Nonbinding Recommendations. Draft Not for Implementation
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Public Notification of Emerging Postmarket Medical Device Signals ( Emerging Signals ) Draft Guidance for Industry
More informationEUROPEAN PARLIAMENT Committee on the Environment, Public Health and Food Safety
EUROPEAN PARLIAMT 2009-2014 Committee on the Environment, Public Health and Food Safety 2012/0266(COD) 12.4.2013 ***I DRAFT REPORT on the proposal for a regulation of the European Parliament and of the
More informationEPF recommendations for the trilogue on the proposal for regulation on Medical Devices
EPF recommendations for the trilogue on the proposal for regulation on Medical Devices Contents 1. Introduction... 3 2. EPF recommendations for the trilogue... 3 2.1 Gaps in Patient safety and quality
More informationFOOD AND DRUGS AUTHORITY GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE
FOOD AND DRUGS AUTHORITY GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE Document No. : FDA/SMC/SMD/GL-QPP/2013/03 Date of First Adoption : 1st February, 2013 Date of Issue : 1 st March, 2013 Version
More informationMedical devices briefing for patients: Patient safety in the new Regulation
Medical devices briefing for patients: Patient safety in the new Regulation 20/12/2016 Patient safety is an important priority for the European Patients Forum, and it was also our main priority in our
More informationGuide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices
Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices SUR-G0003-4 09 JULY 2012 This guide does not purport to be an interpretation of law and/or regulations and
More informationHelping physicians care for patients Aider les médecins à prendre soin des patients
CMA s Response to Health Canada s Consultation Questions Regulatory Framework for the Mandatory Reporting of Adverse Drug Reactions and Medical Device Incidents by Provincial and Territorial Healthcare
More informationLiability Implications for Hospitals of Reprocessing and Reuse of Single-Use Medical Devices
FEATURE Liability Implications for Hospitals of Reprocessing and Reuse of Single-Use Medical Devices By Pamela C. Spencer Concern over escalating healthcare costs has led many Canadian hospitals to reprocess
More informationDrug Safety and Effectiveness Network
Drug Safety and Effectiveness Network The Canadian Association for Population Therapeutics April 21, 2009 Diane Forbes, Associate Director, DSEN Canadian Institutes of Health Research The DSEN at CIHR
More informationZAMBIA MEDICINES REGULATORY AUTHORITY EMPLOYMENT OPPORTUNITY
ZAMBIA MEDICINES REGULATORY AUTHORITY EMPLOYMENT OPPORTUNITY The Zambia Medicines Regulatory Authority (ZAMRA) was set up by the Medicines and Allied Substances Act (No. 3) of 2013 as a statutory body
More informationPost Market Surveillance Requirements. SAMED Regulatory Conference 2 December 2015
Post Market Surveillance Requirements SAMED Regulatory Conference 2 December 2015 Topics Surveillance & Vigilance Adverse Events Reportable Adverse Events Reporting Adverse Events Time frames Exemptions
More informationMinister s Declaration
Explanatory Memorandum to the code of practice on the role of the director of social services issued under part 8 of the Social Services and Well-being (Wales) Act 2014 This Explanatory Memorandum has
More informationOverview of the Regulatory Framework for the Safety of Nuclear Power Plants in Romania
National Commission for Nuclear Activities Control ROMANIA Overview of the Regulatory Framework for the Safety of Nuclear Power Plants in Romania Cantemir Ciurea Director, Nuclear Fuel Cycle Division CNCAN
More informationOfficial Journal of the European Union
L 33/30 DIRECTIVE 2002/98/EC OF THE EUROPEAN PARLIAMT AND OF THE COUNCIL of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of
More informationMINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1
FORUM FOR EXCHANGE OF INFORMATION ON ENFORCEMENT Adopted at the 9 th meeting of the Forum on 1-3 March 2011 MINIMUM CRITERIA FOR REACH AND CLP INSPECTIONS 1 MARCH 2011 1 First edition adopted at the 6
More informationStandards of Practice Non-Prescription Drugs A Report to the National Association of Pharmacy Regulatory Authorities
Standards of Practice Non-Prescription Drugs A Report to the National Association of Pharmacy Regulatory Authorities The following report and proposed standards by Barry E. Allen and Linda G. Suveges were
More informationEuropean IVD Regulations and Risk Based Classification. An Overview for Global Quality Professionals
European IVD Regulations and Risk Based Classification An Overview for Global Quality Professionals Anna Sadio IVD Technical Expert/Project Manager Oct 2013 Caution The new regulations are draft and subject
More informationENDOSCOPY MICROBIOLOGY ALERTS PROCEDURE STANDARD OPERATING PROCEDURE
ENDOSCOPY MICROBIOLOGY ALERTS PROCEDURE STANDARD OPERATING PROCEDURE Version Number V1 Date of Issue December 2017 Reference Number Review Interval Approved By Name: Seamus Hussey Title: Chairperson Endoscopy
More informationLaw on Medical Devices
Law on Medical Devices The Law is published in the Official Gazette of the Republic of Montenegro, no. 79/2004 on 23.12.2004. I GENERAL PROVISIONS Article 1 Manufacturing and distribution of medical devices
More informationFEDERAL REPUBLIC OF NIGERIA
Supplemental Letter No. 1 (Lagos Urban Transport Project) Section 9.02 of the General Conditions Financial and Economic Data In connection with the above Credit to the Republic of Nigeria for the Lagos
More informationUPDATE: Regulatory Framework for Medical Devices in South Africa. SAMED Annual Conference. 14 June 2018 Jerry Molokwane
UPDATE: Regulatory Framework for Medical Devices in South Africa SAMED Annual Conference 14 June 2018 Jerry Molokwane Medicines and Related Substances Act, 1965 (Act 101 of 1965) Act 72 of 2008 and Act
More informationProposed amendments to the Marihuana for Medical Purposes Regulations
Proposed amendments to the Marihuana for Medical Purposes Regulations Submission in response to the Canada Gazette publication on the proposed amendments to the Marihuana for Medical Purposes Regulations
More informationNotice of Proposed Rule Making NPRM 15-03
Notice of Proposed Rule Making NPRM 15-03 16 July 2015 Part 147 Docket 14/CAR/2 Consequential Amendments Part 66 Part 119 Part 145 Published by the Civil Aviation Authority of New Zealand Background to
More information2016 MEDEC Regulatory Conference MAY 9 11, 2016 Transformation through Collaboration
Monday, May 9, 2016 1:30 pm Registration and Coffee 2:30 2:45 pm Welcome to Linda Lindsay, Chair, MEDEC Regulatory Affairs Committee Brief welcome as the official Opening Remarks will take place on Tuesday,
More informationGuideline on good pharmacovigilance practices (GVP)
1 2 26 July 2012 EMA/118465/2012 3 4 Guideline on good pharmacovigilance practices (GVP) Module XV Safety communication 5 Draft finalised by the Agency in collaboration with Member States and submitted
More informationGuideline on good pharmacovigilance practices (GVP)
9 October 2017 2017 EMA/118465/2012 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module XV Safety communication (Rev 1) Date for coming into effect of first version 24 January 2013 Draft
More informationTopic: CAP s Legislative Proposal for Laboratory-Developed Tests (LDT) Date: September 14, 2015
Topic: CAP s Legislative Proposal for Laboratory-Developed Tests (LDT) Date: September 14, 2015 1. What are the CAP s views on the regulatory oversight of laboratory-developed tests (LDTs)? 2. How are
More informationPharmacovigilance Office of Product Review
Pharmacovigilance Office of Product Review Dr Jane Cook Office Head Office of Product Review, Monitoring & Compliance Group, TGA 7/10/2011 Overview of talk Overview Post TGA 21 and OPR New Guidelines Key
More informationMay 12, 2016 MEMORANDUM. Certain provisions of FSMA are already in effect, namely: Mandatory recall authority (FSMA 206).
L A W O F F I C E S 7 0 0 T H I R T E E N T H S T R E E T, N. W. S U I T E 1 2 0 0 W A S H I N G T O N, D. C. 2 0 0 0 5-5 9 2 9 ( 2 0 2 ) 7 3 7-5 6 0 0 F A C S I M I L E ( 2 0 2 ) 7 3 7-9 3 2 9 w w w.
More informationCall for abstracts. Submission deadline: 31 st October Submission guidelines
Call for abstracts Submission deadline: 31 st October 2014 Submission guidelines Please read this information carefully before proceeding to the online submission form. The World Confederation for Physical
More informationRural Community Finance Project. Negotiated financing agreement
Document: EB 2015/LOT/P.37/Sup.1 Date: 17 December 2015 Distribution: Public Original: English E Republic of Liberia Rural Community Finance Project Negotiated financing agreement For: Information Negotiated
More informationNortheast Power Coordinating Council, Inc. Regional Standards Process Manual (RSPM)
DRAFT FOR REVIEW & COMMENT Last Updated 5/15/13 Note to reviewers: Links to NERC website and process flow charts will be finalized for the final review. Northeast Power Coordinating Council, Inc. Regional
More informationGAO MEDICAL DEVICES. Status of FDA s Program for Inspections by Accredited Organizations. Report to Congressional Committees
GAO United States Government Accountability Office Report to Congressional Committees January 2007 MEDICAL DEVICES Status of FDA s Program for Inspections by Accredited Organizations GAO-07-157 Accountability
More informationHuman Samples in Research
Human Samples in Research Adverse Event Reporting Document Identifier HTA-11-SOP-Adverse Event Reporting AUTHOR APPROVER EFFECTIVE DATE: Name and role Signature and date Name and role Signature and date
More informationFood Safety Management System Requirements Comparison - Private & Public Sector Programs - Version 4 19 June 2013
Version 4 19 June v 6.2 January Generic ed 4.1 i FSM 1 ii 117.126 iii Food Safety Plan 2.2.6 iv Eligibility - 3 v ed Preventive Control Plan 2.7 vi ed Preventive Control Plan PCP p. 11 vii Meet scheme
More informationLEGISLATION UPDATE & STATUS OF MCC / SAHPRA and GUIDANCE TO MEET REGULATOR S EXPECTATIONS
LEGISLATION UPDATE & STATUS OF MCC / SAHPRA and GUIDANCE TO MEET REGULATOR S EXPECTATIONS Joey Gouws MCC and Cluster: Food Control, Pharmaceutical Trade and Product Regulation NATIONAL DEPARTMENT OF HEALTH
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Interim Process and Methods of the Highly Specialised Technologies Programme
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Principles Interim Process and Methods of the Highly Specialised Technologies Programme 1. Our guidance production processes are based on key principles,
More informationUNITED STATES OF AMERICA BEFORE THE FEDERAL ENERGY REGULATORY COMMISSION. North American Electric Reliability ) Corporation ) Docket No.
UNITED STATES OF AMERICA BEFORE THE FEDERAL ENERGY REGULATORY COMMISSION North American Electric Reliability ) Corporation ) Docket No. PETITION OF THE NORTH AMERICAN ELECTRIC RELIABILITY CORPORATION FOR
More informationDIRECTIVES. COUNCIL DIRECTIVE 2009/71/EURATOM of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations
L 172/18 Official Journal of the European Union 2.7.2009 DIRECTIVES COUNCIL DIRECTIVE 2009/71/EURATOM of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations
More informationMedical Device Reporting. FD&C Act CFR Direct Final Rule 2/28/05. As amended by:
Medical Device Reporting Direct Final Rule 2/28/05 FD&C Act 519 As amended by: Safe Medical Devices Act of 1990 Medical Device Amendments of 1992 FDA Modernization Act of 1997 Authority to require manufacturers,
More informationI. Rationale, Definition & Use of Professional Practice Standards
FRAMEWORK FOR STANDARDS OF PROFESSIONAL PRACTICE CONTENTS I. Rationale, Definition & Use of Standards of Professional Practice II. Core Professional Practice Expectations for RDs III. Approach to Identifying
More informationBrussels, 12 June 2014 COUNCIL OF THE EUROPEAN UNION 10855/14. Interinstitutional File: 2012/0266 (COD) 2012/0267 (COD)
COUNCIL OF THE EUROPEAN UNION Brussels, 12 June 2014 Interinstitutional File: 2012/0266 (COD) 2012/0267 (COD) 10855/14 PHARM 44 SAN 232 MI 492 COMPET 405 CODEC 1471 NOTE from: General Secretariat of the
More informationIntroduction Patient-Centered Outcomes Research Institute (PCORI)
2 Introduction The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit health research organization authorized by the Patient Protection and Affordable Care Act of 2010. Its
More informationStrengthening Quality and Accountability for Patients Act, 2017 (Bill 160): What You Need to Know. Bill 160: Background
Strengthening Quality and Accountability for Patients Act, 2017 (Bill 160): What You Need to Know Christelle Gedeon, Associate Laurie Turner, Associate October 30, 2017 Bill 160: Background Omnibus legislation
More informationMDUFA Performance Goals and Procedures Process Improvements Pre-Submissions Submission Acceptance Criteria Interactive Review
Page 1 MDUFA Performance Goals and Procedures... 3 I. Process Improvements... 3 A. Pre-Submissions... 3 B. Submission Acceptance Criteria... 4 C. Interactive Review... 5 D. Guidance Document Development...
More informationSTANDARDS FOR ACCREDITATION OF DOCTOR OF CHIROPRACTIC PROGRAMMES
STANDARDS FOR ACCREDITATION OF DOCTOR OF CHIROPRACTIC PROGRAMMES APPROVED BY THE BOARD OF DIRECTORS November 26, 2011 of the CANADIAN FEDERATION OF CHIROPRACTIC REGULATORY AND EDUCATIONAL ACCREDITING BOARDS
More informationNABET Criteria for Food Hygiene (GMP/GHP) Awareness Training Course
NABET Criteria for Food Hygiene (GMP/GHP) Awareness Training Course 0 Section 1: INTRODUCTION 1.1 The Food Hygiene training course shall provide training in the basic concepts of GMP/GHP as per Codex Guidelines
More informationWork of Internal Auditors
IFAC Board Final Pronouncements March 2012 International Standards on Auditing ISA 610 (Revised), Using the Work of Internal Auditors Conforming Amendments to Other ISAs The International Auditing and
More informationHealth Canada Safety Codes
Health Canada Safety Codes Narine Martel, M. Sc. Consumer and Clinical Radiation Protection Bureau Environmental Radiation Health Sciences Directorate Healthy Environments and Consumer Safety Branch February
More informationIndependent Healthcare Regulation. Inspection Methodology
Independent Healthcare Regulation Inspection Methodology March 2018 Healthcare Improvement Scotland 2018 Published March 2018 You can copy or reproduce the information in this document for use within NHSScotland
More informationTrial Management: Trial Master Files and Investigator Site Files
Title: Outcome Statement: Written By: Trial Management: Trial Master Files and Investigator Site Files Staff working on research studies in NSFT will be informed about the requirements of setting up and
More informationLEGISLATIVE ACTS AND OTHER INSTRUMENTS COUNCIL DIRECTIVE establishing a Community framework for the nuclear safety of nuclear installations
COUNCIL OF THE EUROPEAN UNION Brussels, 23 June 2009 (OR. en) 10667/09 Interinstitutional File: 2008/0231 (CNS) ATO 63 LEGISLATIVE ACTS AND OTHER INSTRUMTS Subject: COUNCIL DIRECTIVE establishing a Community
More informationCMDCAS Handbook Policies and Procedures for Sector Qualification under the Canadian Medical Devices Conformity Assessment System (CMDCAS)
CMDCAS Handbook Policies and Procedures for Sector Qualification under the Canadian Medical Devices Conformity Assessment System (CMDCAS) Standards Council of Canada Quality Management Systems Accreditation
More informationUniversal Safety Oversight Audit Programme Continuous Monitoring Manual
Doc 9735 AN/960 Universal Safety Oversight Audit Programme Continuous Monitoring Manual Approved by the Secretary General and published under his authority Third Edition 2011 International Civil Aviation
More informationCOMMISSION IMPLEMENTING REGULATION (EU)
L 253/8 Official Journal of the European Union 25.9.2013 COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council
More informationCode of Governance of Irish Institutes of Technology. Annual Governance Statement and Statement of Internal Control - reporting arrangements to HEA
Code of Governance of Irish Institutes of Technology Annual Governance Statement and Statement of Internal Control - reporting arrangements to HEA The Code of Governance of Irish Institutes of Technology
More informationAGRICULTURE AND FISHERIES - FOOD SAFETY
100 AGRICULTURE AND FISHERIES - FOOD SAFETY. AGRICULTURE AND FISHERIES - FOOD SAFETY BACKGROUND.1 Throughout the years, the Government of Nova Scotia has fulfilled its responsibilities for food safety
More informationHealth System Action Plan: Injectable Sodium Bicarbonate Shortage and Recall Health System Emergency Management Branch June 26, 2017
Ministry of Health and Long-Term Care Health System Action Plan: Injectable Sodium Bicarbonate Shortage and Recall Health System Emergency Management Branch June 26, 2017 Background On June 8, Pfizer Canada
More informationNortheast Power Coordinating Council, Inc. Regional Standard Processes Manual (RSPM)
Northeast Power Coordinating Council, Inc. Regional Standard Processes Manual (RSPM) Approved b y F ERC: December 23, 2014 App r oved by NER C B oard of Trustees: A u gust 14, 2014 App r oved by NPCC B
More informationFood Safety Modernization Act (FSMA)
Food Safety Modernization Act (FSMA) FDA FSMA Timeline July 29, 2009 House version passed Votes 283-142 Nov. 30, 2010 Senate version passed Votes 73-25 Dec. 19, 2010 Senate revised version passed Unanimous
More informationSafety Surveillance for Medical Devices
Safety Surveillance for Medical Devices May 10, 2012 James P. Keller, M.S. Vice President, Health Technology Evaluation and Safety jkeller@ecri.org (610) 825-6000, ext. 5279 Presentation Overview ECRI
More informationLegal and Regulatory Framework on Decommissioning of Research Reactors. Ibrahim MUHAMAD AELB MALAYSIA
(R 2 D 2 P) Legal and Regulatory Framework on Decommissioning of Research Reactors Ibrahim MUHAMAD AELB MALAYSIA Ibrahim Muhamad Principal Assistant Director Atomic Energy Licensing Board Ministry Of Science
More informationMICHAEL N. FEUER CITY ATTORNEY REPORT RE:
MICHAEL N. FEUER CITY ATTORNEY REPORT RE: R13-0351 REPORTNO.~~ ~ DEC 0 9 2013 DRAFT ORDINANCE FOR THE HAIWEE POWER PLANT PENSTOCK REPLACEMENT PROJECT REQUESTING THE LOS ANGELES CITY COUNCIL TO ESTABLISH
More informationNOT PROTECTIVELY MARKED
Title of document ONR GUIDE LC 13 NUCLEAR SAFETY COMMITTEE Document Type: Unique Document ID and Revision No: Nuclear Safety Technical Inspection Guide Revision 4 Date Issued: July 2016 Review Date: July
More informationHospital and Other Healthcare Facilities
Hospital and Other Healthcare Facilities Council Progress Report December 2015 Judy Chong, RPh, BScPhm Manager, Hospital and Other Healthcare Facilities Agenda Background Drug Preparation Premises (DPPs)
More informationPLAN OF ACTION FOR IMPLEMENTATION OF 510(K) AND SCIENCE RECOMMENDATIONS
PLAN OF ACTION FOR IMPLEMENTATION OF 510(K) AND SCIENCE RECOMMENDATIONS In August 2010, the Food and Drug Administration s Center for Devices and Radiological Health (CDRH or the Center) released for public
More informationEUROPEAN PARLIAMENT Plenary sitting
EUROPEAN PARLIAMT 2009-2014 Plenary sitting A7-0324/2013 9.10.2013 ***I REPORT on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive
More informationPRIVACY POLICY USES AND DISCLOSURES FOR TREATMENT, PAYMENT, AND HEALTH CARE OPERATIONS
PRIVACY POLICY As of April 14, 2003, the Federal regulation on patient information privacy, known as the Health Insurance Portability and Accountability Act (HIPAA), requires that we provide (in writing)
More informationGuide to reporting drug shortages and discontinuations GUI-0120
Guide to reporting drug shortages and discontinuations GUI-0120 March 14, 2017 Guide to reporting drug shortages and discontinuations (GUI-0120) Author: Health Products Compliance Directorate Date issued:
More informationAWARDING FIXED OBLIGATION GRANTS TO NON-GOVERNMENTAL ORGANIZATIONS
AWARDING FIXED OBLIGATION GRANTS TO NON-GOVERNMENTAL ORGANIZATIONS An Additional Help Document For ADS Chapter 303 New Reference: 11/08/2010 Responsible Office: M/OAA File Name: 303saj_110810 I. PURPOSE
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL GUIDELINES FOR RECALL/ WITHDRAWAL OF MEDICINES This document has been prepared to serve as a recommendation to applicants regarding the recalls of medicines, and the Medicines
More informationComplementary and Alternative Health Care and Natural Health Products Standards
Standards Complementary and Alternative Health Care and Natural Health Products Standards Month Year NATURAL HEALTH PRODUCTS i Approved by the College and Association of Registered Nurses of Alberta ()
More informationApril 17, Edition of the Joint Commission International Accreditation. SUBJECT: MITA Feedback on the 5 th Standards for Hospitals
1300 North 17 th Street Suite 1752 Arlington, Virginia 22209 Tel: 703.841.3200 Fax: 703.841.3392 www.medicalimaging.org April 17, 2013 Paul vanostenberg, DDS, MS Vice President Accreditation and Standards
More informationSASKATCHEWAN ASSOCIATIO. RN Specialty Practices: RN Guidelines
SASKATCHEWAN ASSOCIATIO N RN Specialty Practices: RN Guidelines July 2016 2016, Saskatchewan Registered Nurses Association 2066 Retallack Street Regina, SK S4T 7X5 Phone: (306) 359-4200 (Regina) Toll Free:
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL QUESTIONS & ANSWERS: LICENSING OF MEDICAL DEVICE ESTABLISHMENTS This document is intended to provide clarity on guidelines and applications for the licensing of medical device
More informationHealth Physicist Series
Health Physicist Series California State Personnel Board Specification Series established October 17, 1978 Scope This series specification describes five six threelevels of professional classes which specialize
More informationAbu Dhabi Occupational Safety and Health System Framework (OSHAD-SF) Mechanisms
Abu Dhabi Occupational Safety and Health System Framework (OSHAD-SF) Mechanisms Mechanism 2.0 OSHAD-SF Administration Version 3.1 March 2017 Table of Contents 1. Introduction... 3 2. Roles and Responsibilities...
More informationQuality Assurance/Quality Control Procedures for Environmental Documents
Environmental Handbook Quality Assurance/Quality Control Procedures for Environmental s This handbook outlines processes to be used by the project sponsor and department delegate in quality assurance and
More informationRecord of Proceedings, Including Reasons for Decision
Record of Proceedings, Including Reasons for Decision In the Matter of Applicant Ontario Power Generation Inc. Subject Application to Amend the Pickering A Nuclear Generating Station Power Reactor Operating
More informationThe registration department at Kuwait Drug and Food Control Administration (KDFCA) monitors and
Appendix 1 Background on some of the pharmaceutical sectors in Kuwait Registration The registration department at Kuwait Drug and Food Control Administration (KDFCA) monitors and supervises all pharmaceuticals,
More informationXL Foods Inc. Independent Review Recommendations and Government Action Plan
XL Foods Inc. Independent Review Recommendations and Government Action Plan Recommendations 1. A strong food safety culture must be developed within the processing plant, and adopted by both plant and
More informationRe: Docket No. FDA 2013-N-0500 Proposed Rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
March 13, 2014 BY ELECTRONIC DELIVERY Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA 2013-N-0500 Proposed Rule: Supplemental
More informationUnlicensed medicines ( specials ) Current issues related to unlicensed medicines and a suggested approach to devising a coherent sourcing strategy
Unlicensed medicines ( specials ) Current issues related to unlicensed medicines and a suggested approach to devising a coherent sourcing strategy Andrew Tittershill Content Personal introduction. Defining
More informationAdopted by Pharmacovigilance Risk Assessment Committee 20 February Adopted by Pharmacovigilance Inspectors Working Group 21 March 2014
21 March 2014 EMA/INS/PhV/192231/2014 Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal Adopted
More informationThe New EU PV Legislation: View from the European Commission
The New EU PV Legislation: View from the European Commission International seminar 26 May 2011 Lenita LINDSTRÖM Senior Policy Officer Pharmaceuticals Unit/DG SANCO Rationale for the revision Calls for
More informationOverview of ICH. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
Overview of ICH June 2018 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH Legal notice Legal Notice This presentation is protected by copyright and
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL REPORTING ADVERSE DRUG REACTIONS IN SOUTH AFRICA IMPORTANT NOTE This guideline applies only to the reporting of SAEs during clinical trials. An update of the guideline for this
More informationSecretariat. United Nations ST/SGB/2006/10. Secretary-General s bulletin. Establishment and operation of the Central Emergency Response Fund
United Nations ST/SGB/2006/10 Secretariat 10 October 2006 Secretary-General s bulletin Establishment and operation of the Central Emergency Response Fund The Secretary-General, pursuant to section 3.2
More informationStatutes of the Copernicus Science Centre I. GENERAL PROVISIONS
Statutes of the Copernicus Science Centre I. GENERAL PROVISIONS 1 The cultural institution known as The Copernicus Science Centre, hereinafter the Science Centre, operates in particular on the basis of:
More informationThe Paramedics Act. SASKATCHEWAN COLLEGE OF PARAMEDICS REGULATORY BYLAWS [amended May 2, 2017]
The Paramedics Act SASKATCHEWAN COLLEGE OF PARAMEDICS REGULATORY BYLAWS [amended May 2, 2017] The following are the regulatory bylaws for the Saskatchewan College of Paramedics: Membership 1. Categories,
More informationGUIDELINES FOR CRITERIA AND CERTIFICATION RULES ANNEX - JAWDA Data Certification for Healthcare Providers - Methodology 2017.
GUIDELINES FOR CRITERIA AND CERTIFICATION RULES ANNEX - JAWDA Data Certification for Healthcare Providers - Methodology 2017 December 2016 Page 1 of 14 1. Contents 1. Contents 2 2. General 3 3. Certification
More informationSubject to Filing with Minister of Health
Pharmacy Operations and Drug Scheduling Act - BYLAWS Table of Contents 1. Definitions PART I Pharmacy Licences 2. Licence Types 3. New Community Pharmacy Licence 4. Community Pharmacy Licence Renewal 5.
More informationNovember Innovative Medicines Initiative (IMI) Intellectual Property (IP) Policy. Guidance Note for IMI Applicants and Participants
Innovative Medicines Initiative (IMI) Intellectual Property (IP) Policy Guidance Note for IMI Applicants and Participants 1. INTRODUCTION The purpose of this guidance note 1 is: - to clarify the IMI IP
More informationBilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA Classification, labelling and packaging of substances and mixtures - CLP
REPUBLIC OF SERBIA Negotiating Group for the Chapter 27 Environment and Climate Change Bilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA Classification, labelling and packaging of
More informationFINAL STATUS DOCUMENT
GHTF/SG2/N68R3: 2005 FINAL STATUS DOCUMENT Global Harmonization Task Force Title: Summary of Current Requirements for Where to Send Adverse Event Reports. Authoring Group: GHTF Study Group 2 Endorsed by:
More information