LEADER 05578nam 2200685 450 001 9910460246203321 005 20200520144314.0 010 $a0-85709-920-5 035 $a(CKB)3710000000269928 035 $a(EBL)1826807 035 $a(SSID)ssj0001414487 035 $a(PQKBManifestationID)11870955 035 $a(PQKBTitleCode)TC0001414487 035 $a(PQKBWorkID)11432021 035 $a(PQKB)10592748 035 $a(MiAaPQ)EBC1826807 035 $a(CaSebORM)9780857095428 035 $a(Au-PeEL)EBL1826807 035 $a(CaPaEBR)ebr10966280 035 $a(CaONFJC)MIL658378 035 $a(OCoLC)894171659 035 $a(EXLCZ)993710000000269928 100 $a20141113h20152015 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aRegulatory affairs for biomaterials and medical devices /$fedited by Stephen F. Amato and Robert M. Ezzell Jr. ; contributors S. F. Amato [and ten others] 205 $a1st edition 210 1$aCambridge, England :$cWoodhead Publishing,$d2015. 210 4$dİ2015 215 $a1 online resource (203 p.) 225 1 $aWoodhead Publishing Series in Biomaterials ;$vNumber 79 300 $aDescription based upon print version of record. 311 $a0-85709-542-0 311 $a1-322-27098-8 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $aCover; Regulatory Affairs for Biomaterials and Medical Devices; Copyright; Contents; List of contributors; Woodhead Publishing Series in Biomaterials; 1 Biomaterials and their applications in medicine; 1.1 Biomaterials - progression of the definition; 1.2 The history and future of biomaterials; 1.3 Types of biomaterials; 1.4 The major factors contributing to specific biomaterial choices; 1.5 Important parameters in the development of biomaterials and associated products; 1.6 Applications of biomaterials; 1.7 Sources of further information and advice; References 327 $a2 Technical considerations for commercialization of biomaterials2.1 Introduction; 2.2 General considerations; 2.3 Regulation of risks associated with medical products; 2.4 Ensuring the safety of medical products; 2.5 Demonstrating the efficacy of biomaterials; 2.6 Specific product scenarios; 2.7 Biologically derived materials; 2.8 Understanding and complying with FDA guidelines; 2.9 Conclusion; References; 3 Regulatory strategies for biomaterials and medical devices in the USA: classification, design, and risk analysis 327 $a3.1 Food and Drug Administration (FDA) regulatory categorizations and structure3.2 FDA classification of medical devices; 3.3 FDA Quality Systems Regulations (QSR) for medical device and biomaterial design control; 3.4 Medical device and biomaterial risk analysis; 3.5 Procurement and related processes; References; 4 Clinical development and endpoint strategies for biomaterialsand medical devices; 4.1 Food and Drug Administration (FDA) regulatory considerations for biomaterials; 4.2 Clinical development pathways for device-based classification 327 $a4.3 Testing considerations for biomaterials clinical evaluation4.4 Clinical development pathways for biologic-based classification; 4.5 Clinical development pathways for combination product classification; 4.6 Clinical development elements required in biomaterials product evaluation in all regulatory pathways; Appendix 1: Applicable FDA guidance documents and ASTM standards for biomaterials; Appendix 2: Applicable FDA product codes and target areas for Class II biomaterials; 5 The clinical evaluation and approval threshold of biomaterialsand medical devices 327 $a5.1 The clinical evaluation of biomaterials and medical devices5.2 Geographical differences in clinical evaluations; 5.3 Clinical quality assurance; 5.4 Threshold for approval; 5.5 The current regulatory landscape; 5.6 Future trends; References; 6 Supply chain controls for biomaterials and medical devices in the USA; 6.1 Introduction; 6.2 Overview of supply chain risks and mitigating activities; 6.3 Product distribution: traditional and emerging risks; 6.4 Counterfeit challenges; 6.5 Challenges relating to recalls, imports and environmental management; 6.6 Risk management system 327 $a6.7 Regulatory risks affecting sponsor oversight of a supplier 330 $aAll biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller companies who may not emplo 410 0$aWoodhead Publishing series in biomaterials ;$vNumber 79. 606 $aMedical instruments and apparatus$xSafety regulations 608 $aElectronic books. 615 0$aMedical instruments and apparatus$xSafety regulations. 676 $a344.041 702 $aAmato$b Stephen F. 702 $aEzzell$b Robert M. 702 $aAmato$b S. F. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910460246203321 996 $aRegulatory affairs for biomaterials and medical devices$92454618 997 $aUNINA LEADER 04494nam 2200769Ia 450 001 9910956926203321 005 20250313204944.0 010 $a9786610060641 010 $a9781280060649 010 $a1280060646 010 $a9789240681071 010 $a9240681078 035 $a(CKB)111087028330494 035 $a(SSID)ssj0000216169 035 $a(PQKBManifestationID)11184958 035 $a(PQKBTitleCode)TC0000216169 035 $a(PQKBWorkID)10197116 035 $a(PQKB)10978867 035 $a(MiAaPQ)EBC284615 035 $a(Au-PeEL)EBL284615 035 $a(CaPaEBR)ebr10047406 035 $a(CaONFJC)MIL6064 035 $a(OCoLC)55664178 035 $a(EXLCZ)99111087028330494 100 $a20040213d2003 my 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aOrganization of services for mental health $emental health policy and service guidance package 205 $a1st ed. 210 $a[Geneva] $cWorld Health Organization$d2003 215 $a90 p 225 0 $aMental health policy and service guidance package Organization of services for mental health 300 $aBibliographic Level Mode of Issuance: Monograph 311 08$a9789241545921 311 08$a9241545925 327 $aIntro -- Table of contents -- Preface -- Executive summary -- Aims and target audience -- 1. Introduction -- 2. Description and analysis of mental health services around the world -- 2.1 Mental health services integrated into the general health system -- 2.2 Community mental health services -- 2.3 Institutional services in mental hospitals -- 3. Current status of service organization around the world -- 4. Guidance for organizing services -- 4.1 Principles for the organization of services -- 4.2 Establishment of an optimal mix of services -- 4.3 Integration of mental health services into general health services -- 4.4 Creation of formal and informal community mental health services -- 4.5 Limitation of dedicated mental hospitals -- 5. Key issues in the organization of mental health services -- 5.1 Evidence-based care -- 5.2 Episodic care versus continuing care -- 5.3 Pathways to care -- 5.4 Geographical disparities -- 5.5 Service-led care versus needs-led care -- 5.6 Collaboration within and between sectors -- 6. Recommendations and conclusions -- 7. Scenarios for the organization of services in countries with various levels of resources -- 8. Barriers and solutions -- 9. Glossary -- References. 330 $aMental health services make it possible to deliver effective interventions. The way these services are organized has an important bearing on their effectiveness and the ultimate fulfilment of the aims and objectives of national mental health policies. This module begins with a description and analysis of the current forms of mental health service organisation found around the world. The current status of service organisation is reviewed and recommendations are made for organising mental health services, based on an optimal mix of a variety of services. The main recommendations are to integrate mental health services into general health care systems; develop formal and informal community mental health services; and promote and implement deinstitutionalization once alternative services are in place. 517 3 $aMental health policy and service guidance package 606 $aMental health planning 606 $aMental health services$xAdministration 606 $aCommunity mental health services$xAdministration 606 $aCommunity mental health services$xPlanning 606 $aPublic health 606 $aMedical policy 606 $aDelivery of Health Care 606 $aMental Health Services$xorganization and administration 608 $aGuideline. 615 0$aMental health planning. 615 0$aMental health services$xAdministration. 615 0$aCommunity mental health services$xAdministration. 615 0$aCommunity mental health services$xPlanning. 615 0$aPublic health. 615 0$aMedical policy. 615 2$aDelivery of Health Care. 615 2$aMental Health Services$xorganization and administration. 676 $a362.2/068 712 02$aWorld Health Organization. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910956926203321 996 $aOrganization of services for mental health$94328637 997 $aUNINA