Verfügbarkeit: Medical Product Regulatory Affairs

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

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Bibliographische Detailangaben
1. Verfasser:	Tobin, John J. (VerfasserIn)
Format:	Elektronisch E-Book
Sprache:	English
Veröffentlicht:	Newark John Wiley & Sons, Incorporated 2023
Ausgabe:	2nd ed
Schlagworte:	Europäische Union Drugs-Law and legislation Pharmacy-Law and legislation Arzneimittelrecht USA
Online-Zugang:	DE-2070s
Beschreibung:	Description based on publisher supplied metadata and other sources
Beschreibung:	1 Online-Ressource (333 Seiten)
ISBN:	9783527688975

Internformat

MARC


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245	1	0	\|a Medical Product Regulatory Affairs \|b Pharmaceuticals, Diagnostics, Medical Devices
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505	8		\|a Cover -- Title Page -- Copyright -- Contents -- Chapter 1 The Aims and Structure of Regulations -- 1.1 Introduction -- 1.2 Purpose and Principles of Regulation -- 1.3 The Legal Framework for Regulation -- 1.3.1 National Legislative Process -- 1.3.2 EU Legislative Process -- 1.3.3 Working with Legal Texts -- 1.3.4 Guidance Documents -- 1.3.5 Pharmacopoeia -- 1.4 Basic Legislation -- 1.4.1 EU Legislation -- 1.4.2 US Legislation -- 1.5 Scope of the Legislation -- 1.6 Chapter Review -- 1.7 Further Reading -- Chapter 2 Regulatory Strategy -- 2.1 Chapter Introduction -- 2.2 Basic Regulatory Strategy -- 2.2.1 Product Development -- 2.2.2 Product Manufacture -- 2.2.3 Market Vigilance -- 2.3 Quality Assurance Systems -- 2.3.1 Personnel -- 2.3.2 Documentation -- 2.3.3 Facilities and Equipment -- 2.3.4 Corrective and Preventative Action -- 2.4 Validation -- 2.5 Regulatory Bodies -- 2.5.1 European Commission -- 2.5.2 The EMA -- 2.5.3 National Competent Authorities -- 2.5.4 Notified Bodies -- 2.5.5 The FDA -- 2.5.6 US Department of Agriculture (USDA) -- 2.5.7 Pharmacopoeia Authorities -- 2.6 International Harmonisation Bodies -- 2.7 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use -- 2.7.1 VICH -- 2.7.2 The International Medical Device Regulators Forum (IMDRF) -- 2.8 Pharmaceutical Inspection Cooperation Scheme (PICS) -- 2.9 The World Health Organisation (WHO) -- 2.10 Chapter Review -- 2.11 Further Reading -- Chapter 3 Drug Discovery, Classification and Early Stage Development -- 3.1 Chapter Introduction -- 3.2 Drug Categorisation -- 3.2.1 Prescription Status -- 3.2.2 Physical Properties -- 3.2.3 Mode of Action -- 3.2.4 Therapeutic Use -- 3.3 Drug Discovery -- 3.3.1 Target Discovery and Validation -- 3.3.2 Lead Discovery, Validation and Optimisation -- 3.4 Drug Development -- 3.4.1 Manufacture and Control
505	8		\|a 3.5 Drug Delivery -- 3.5.1 Location -- 3.5.2 Drug Characteristics -- 3.5.3 Speed and Duration of Therapeutic Effect -- 3.5.4 Stability -- 3.6 Chapter Review -- 3.7 Further Reading -- Chapter 4 Non‐clinical Studies -- 4.1 Chapter Introduction -- 4.2 Non‐clinical Study Objectives and Timing -- 4.3 Pharmacological Studies -- 4.3.1 Pharmacodynamic Studies -- 4.3.2 Pharmacokinetic/Toxicokinetic Studies -- 4.4 Bioavailability and Bioequivalence -- 4.5 Toxicology Studies -- 4.5.1 Toxicity Studies -- 4.5.2 Genotoxicity Studies -- 4.5.3 Carcinogenicity Studies -- 4.5.4 Reproductive Toxicology Studies -- 4.6 Chemistry, Manufacturing and Control Development (CMC) -- 4.7 Quality by Design (QbD) -- 4.8 Quality of Biotech Products -- 4.8.1 Stability Studies -- 4.9 Good Laboratory Practice (GLP) -- 4.10 Chapter Review -- 4.11 Further Reading -- Chapter 5 Clinical Trials -- 5.1 Chapter Introduction -- 5.2 Clinical Trials -- 5.2.1 Phase I Trials -- 5.2.2 Phase II Trials -- 5.2.3 Phase III Trials -- 5.3 Clinical Trial Design -- 5.4 Good Clinical Practice -- 5.5 Clinical Trials in the EU -- 5.5.1 Sponsor -- 5.5.2 Investigator's Brochure (IB) -- 5.5.3 Investigator -- 5.5.4 Trial Protocol -- 5.5.5 Investigational Medicinal Product Dossier (IMPD) -- 5.5.6 Informed Consent -- 5.5.7 Manufacture of Investigational Medicinal Product -- 5.5.8 Clinical Trial Authorisation -- 5.5.9 Independent Ethics Committee Opinion -- 5.5.10 Amendments to Clinical Trials -- 5.5.11 Case Report Forms (CRFs) -- 5.5.12 Adverse Event Reporting -- 5.5.13 Annual Safety Report -- 5.5.14 Monitoring of Trials -- 5.5.15 End of Trial -- 5.5.16 Trial Master File -- 5.6 Clinical Trials in the US -- 5.6.1 Investigational New Drug Application (IND) -- 5.6.2 Institutional Review Board (IRB) -- 5.6.3 Communication with the FDA -- 5.6.4 Labelling of Investigational Drugs
505	8		\|a 5.6.5 Registry of Clinical Trial Information -- 5.7 Chapter Review -- 5.8 Further Reading -- Chapter 6 Marketing Authorisation -- 6.1 Chapter Introduction -- 6.2 The Application Dossier -- 6.3 CTD -- 6.3.1 Module Structure -- 6.3.2 Module 3 - Quality -- 6.3.3 Drug Master Files -- 6.3.4 Module 4 - Non‐clinical Study Reports -- 6.3.5 Module 5 - Clinical Study Reports -- 6.3.6 Module 2 - Summaries -- 6.3.7 Module I - Region Specific -- 6.3.8 Module 1 - EU -- 6.3.9 Module 1 - US -- 6.4 Submission and Review Process in the EU -- 6.4.1 Union Authorisation -- 6.4.2 Scientific Evaluation Process -- 6.4.3 Decision Making Process -- 6.4.4 National Authorisations -- 6.4.5 Decentralised Procedure -- 6.4.6 Mutual Recognition Procedure -- 6.4.7 Plasma Master Files and Vaccine Antigen Master Files -- 6.5 Submission and Review Process in the US -- 6.6 Chapter Review -- 6.7 Further Reading -- Chapter 7 Authorisation of Veterinary Medicines -- 7.1 Chapter Introduction -- 7.2 Overview of Development Process for Veterinary Medicines -- 7.2.1 Pre‐clinical Studies -- 7.2.2 Clinical Trials -- 7.2.3 Good Clinical Practices -- 7.3 Authorisation of Clinical Trials in the EU -- 7.4 Authorisation of Clinical Trials in the US -- 7.5 Maximum Residue Limits (MRLs) -- 7.6 Authorisation of Veterinary Medicines in the EU -- 7.6.1 Applications to Establish MRLs -- 7.6.2 Review of Applications and Establishment of MRLs -- 7.6.3 Marketing Authorisations -- 7.6.4 Presentation of the Dossier -- 7.7 Approval of Veterinary Medicines in the US -- 7.7.1 New Animal Drug Application (NADA) -- 7.7.2 Approval of Veterinary Biological Products -- 7.8 Chapter Review -- 7.9 Further Reading -- Chapter 8 Variations to the Drug Authorisation Process -- 8.1 Chapter Introduction -- 8.2 Provisions in Support of Special Drug Applications -- 8.2.1 Orphan Drugs -- 8.2.2 Paediatric Applications
505	8		\|a 8.3 Accelerated Access to New Drug Therapies -- 8.3.1 EMA Accelerated Review and Conditional Marketing Routes -- 8.3.2 EU Compassionate Use -- 8.3.3 Expedited Pathways in the US -- 8.3.4 Expanded Access and Emergency Use Authorization (EUA) -- 8.4 Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible -- 8.5 Animal Drugs for Minor Use and Minor Species -- 8.5.1 Conditional Approval -- 8.5.2 Indexing -- 8.5.3 Designation -- 8.6 Special Provisions to Facilitate Access to Drugs for Animal Treatment in the EU -- 8.7 Changes to an Authorised Drug -- 8.8 EU System for Processing Changes -- 8.8.1 Extension Applications -- 8.8.2 Major Variation (Type II) -- 8.8.3 Minor Variation (Type IA or IB) -- 8.9 Processing Changes in the US -- 8.9.1 Manufacturing Change Supplements -- 8.9.2 Major Changes -- 8.9.3 Moderate Changes -- 8.9.4 Minor Changes -- 8.10 Authorisation of Generic Drugs -- 8.10.1 EU Regulations -- 8.10.2 US Regulations -- 8.11 Biosimilars -- 8.11.1 EU Regulations -- 8.11.2 US Regulations -- 8.12 Reference Drug Exclusivity -- 8.13 Other Authorisation Procedures -- 8.13.1 Well‐Established Medical Use Products -- 8.13.2 Combination Products -- 8.13.3 Homeopathic Medicines -- 8.13.4 Traditional Herbal Medicines -- 8.13.5 US Regulation of OTC Drugs -- 8.14 Chapter Review -- 8.15 Further Reading -- Chapter 9 Medical Devices -- 9.1 Chapter Introduction -- 9.2 Regulatory Strategy for Medical Devices in the EU -- 9.2.1 Use of Standards to Establish Conformity -- 9.2.2 Classification of Devices -- 9.3 Regulatory Strategy for Medical Devices in the US -- 9.3.1 Classification of Devices -- 9.3.1.1 Class I -- 9.3.1.2 Class II -- 9.3.1.3 Class III -- 9.3.2 Classification of New Devices -- 9.4 Development of Devices -- 9.4.1 Design Controls -- 9.4.2 Design and Development Planning -- 9.4.3 Design Input -- 9.4.4 Design Output
505	8		\|a 9.4.5 Design Verification and Design Validation -- 9.4.6 Design Review -- 9.4.7 Risk Analysis -- 9.4.8 Design Changes -- 9.5 Chapter Review -- 9.6 Further Reading -- Chapter 10 Authorisation of Medical Devices -- 10.1 Chapter Introduction -- 10.2 Evaluation of Medical Devices in Europe -- 10.2.1 Clinical Evaluation -- 10.2.2 Clinical Investigations -- 10.2.3 Performance Evaluation of IVDs -- 10.2.4 Performance Studies of IVDs -- 10.3 Evaluation of Medical Devices in the US -- 10.3.1 Exempted Investigations -- 10.3.2 Abbreviated Requirement Investigations -- 10.3.3 IDE Investigations -- 10.3.4 Labelling of Devices for Investigational Use -- 10.4 Placing of Devices on the Market in the EU -- 10.4.1 Designation of Notified Bodies -- 10.4.2 Conformity Assessment Procedures -- 10.4.2.1 Conformity Assessment Based on a Quality Management System and Assessment of Technical Documentation -- 10.4.2.2 EU Type‐Examination -- 10.4.2.3 Production Quality Assurance -- 10.4.2.4 EU Verification -- 10.4.2.5 EU (Self) Declaration of Conformity -- 10.4.3 Technical Documentation -- 10.4.4 Labelling Requirements -- 10.4.5 Registration of Economic Operators and Devices -- 10.5 Placing of Devices on the Market in the US -- 10.5.1 510(k) Pre‐market Notification -- 10.5.2 Traditional 510(k) -- 10.5.3 Abbreviated 510(k) -- 10.5.4 Special 510(k) -- 10.5.5 De Novo 510(k) -- 10.5.6 Notification and Review Procedures -- 10.5.7 Pre‐market Approval (PMA) -- 10.5.8 Changes to a PMA‐Approved Device -- 10.5.9 Humanitarian Use Devices (HUDs) -- 10.5.10 Labelling of Devices -- 10.6 Chapter Review -- 10.7 Further Reading -- Chapter 11 Good Manufacturing Practice (GMP) -- 11.1 Chapter Introduction -- 11.2 Drug GMP Regulations and Guidance -- 11.3 Essential GMP Requirements -- 11.3.1 Quality Assurance System -- 11.3.2 Personnel -- 11.3.3 Premises and Equipment -- 11.3.4 Documentation
505	8		\|a 11.3.5 Production
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Datensatz im Suchindex

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author	Tobin, John J.
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contents	Cover -- Title Page -- Copyright -- Contents -- Chapter 1 The Aims and Structure of Regulations -- 1.1 Introduction -- 1.2 Purpose and Principles of Regulation -- 1.3 The Legal Framework for Regulation -- 1.3.1 National Legislative Process -- 1.3.2 EU Legislative Process -- 1.3.3 Working with Legal Texts -- 1.3.4 Guidance Documents -- 1.3.5 Pharmacopoeia -- 1.4 Basic Legislation -- 1.4.1 EU Legislation -- 1.4.2 US Legislation -- 1.5 Scope of the Legislation -- 1.6 Chapter Review -- 1.7 Further Reading -- Chapter 2 Regulatory Strategy -- 2.1 Chapter Introduction -- 2.2 Basic Regulatory Strategy -- 2.2.1 Product Development -- 2.2.2 Product Manufacture -- 2.2.3 Market Vigilance -- 2.3 Quality Assurance Systems -- 2.3.1 Personnel -- 2.3.2 Documentation -- 2.3.3 Facilities and Equipment -- 2.3.4 Corrective and Preventative Action -- 2.4 Validation -- 2.5 Regulatory Bodies -- 2.5.1 European Commission -- 2.5.2 The EMA -- 2.5.3 National Competent Authorities -- 2.5.4 Notified Bodies -- 2.5.5 The FDA -- 2.5.6 US Department of Agriculture (USDA) -- 2.5.7 Pharmacopoeia Authorities -- 2.6 International Harmonisation Bodies -- 2.7 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use -- 2.7.1 VICH -- 2.7.2 The International Medical Device Regulators Forum (IMDRF) -- 2.8 Pharmaceutical Inspection Cooperation Scheme (PICS) -- 2.9 The World Health Organisation (WHO) -- 2.10 Chapter Review -- 2.11 Further Reading -- Chapter 3 Drug Discovery, Classification and Early Stage Development -- 3.1 Chapter Introduction -- 3.2 Drug Categorisation -- 3.2.1 Prescription Status -- 3.2.2 Physical Properties -- 3.2.3 Mode of Action -- 3.2.4 Therapeutic Use -- 3.3 Drug Discovery -- 3.3.1 Target Discovery and Validation -- 3.3.2 Lead Discovery, Validation and Optimisation -- 3.4 Drug Development -- 3.4.1 Manufacture and Control 3.5 Drug Delivery -- 3.5.1 Location -- 3.5.2 Drug Characteristics -- 3.5.3 Speed and Duration of Therapeutic Effect -- 3.5.4 Stability -- 3.6 Chapter Review -- 3.7 Further Reading -- Chapter 4 Non‐clinical Studies -- 4.1 Chapter Introduction -- 4.2 Non‐clinical Study Objectives and Timing -- 4.3 Pharmacological Studies -- 4.3.1 Pharmacodynamic Studies -- 4.3.2 Pharmacokinetic/Toxicokinetic Studies -- 4.4 Bioavailability and Bioequivalence -- 4.5 Toxicology Studies -- 4.5.1 Toxicity Studies -- 4.5.2 Genotoxicity Studies -- 4.5.3 Carcinogenicity Studies -- 4.5.4 Reproductive Toxicology Studies -- 4.6 Chemistry, Manufacturing and Control Development (CMC) -- 4.7 Quality by Design (QbD) -- 4.8 Quality of Biotech Products -- 4.8.1 Stability Studies -- 4.9 Good Laboratory Practice (GLP) -- 4.10 Chapter Review -- 4.11 Further Reading -- Chapter 5 Clinical Trials -- 5.1 Chapter Introduction -- 5.2 Clinical Trials -- 5.2.1 Phase I Trials -- 5.2.2 Phase II Trials -- 5.2.3 Phase III Trials -- 5.3 Clinical Trial Design -- 5.4 Good Clinical Practice -- 5.5 Clinical Trials in the EU -- 5.5.1 Sponsor -- 5.5.2 Investigator's Brochure (IB) -- 5.5.3 Investigator -- 5.5.4 Trial Protocol -- 5.5.5 Investigational Medicinal Product Dossier (IMPD) -- 5.5.6 Informed Consent -- 5.5.7 Manufacture of Investigational Medicinal Product -- 5.5.8 Clinical Trial Authorisation -- 5.5.9 Independent Ethics Committee Opinion -- 5.5.10 Amendments to Clinical Trials -- 5.5.11 Case Report Forms (CRFs) -- 5.5.12 Adverse Event Reporting -- 5.5.13 Annual Safety Report -- 5.5.14 Monitoring of Trials -- 5.5.15 End of Trial -- 5.5.16 Trial Master File -- 5.6 Clinical Trials in the US -- 5.6.1 Investigational New Drug Application (IND) -- 5.6.2 Institutional Review Board (IRB) -- 5.6.3 Communication with the FDA -- 5.6.4 Labelling of Investigational Drugs 5.6.5 Registry of Clinical Trial Information -- 5.7 Chapter Review -- 5.8 Further Reading -- Chapter 6 Marketing Authorisation -- 6.1 Chapter Introduction -- 6.2 The Application Dossier -- 6.3 CTD -- 6.3.1 Module Structure -- 6.3.2 Module 3 - Quality -- 6.3.3 Drug Master Files -- 6.3.4 Module 4 - Non‐clinical Study Reports -- 6.3.5 Module 5 - Clinical Study Reports -- 6.3.6 Module 2 - Summaries -- 6.3.7 Module I - Region Specific -- 6.3.8 Module 1 - EU -- 6.3.9 Module 1 - US -- 6.4 Submission and Review Process in the EU -- 6.4.1 Union Authorisation -- 6.4.2 Scientific Evaluation Process -- 6.4.3 Decision Making Process -- 6.4.4 National Authorisations -- 6.4.5 Decentralised Procedure -- 6.4.6 Mutual Recognition Procedure -- 6.4.7 Plasma Master Files and Vaccine Antigen Master Files -- 6.5 Submission and Review Process in the US -- 6.6 Chapter Review -- 6.7 Further Reading -- Chapter 7 Authorisation of Veterinary Medicines -- 7.1 Chapter Introduction -- 7.2 Overview of Development Process for Veterinary Medicines -- 7.2.1 Pre‐clinical Studies -- 7.2.2 Clinical Trials -- 7.2.3 Good Clinical Practices -- 7.3 Authorisation of Clinical Trials in the EU -- 7.4 Authorisation of Clinical Trials in the US -- 7.5 Maximum Residue Limits (MRLs) -- 7.6 Authorisation of Veterinary Medicines in the EU -- 7.6.1 Applications to Establish MRLs -- 7.6.2 Review of Applications and Establishment of MRLs -- 7.6.3 Marketing Authorisations -- 7.6.4 Presentation of the Dossier -- 7.7 Approval of Veterinary Medicines in the US -- 7.7.1 New Animal Drug Application (NADA) -- 7.7.2 Approval of Veterinary Biological Products -- 7.8 Chapter Review -- 7.9 Further Reading -- Chapter 8 Variations to the Drug Authorisation Process -- 8.1 Chapter Introduction -- 8.2 Provisions in Support of Special Drug Applications -- 8.2.1 Orphan Drugs -- 8.2.2 Paediatric Applications 8.3 Accelerated Access to New Drug Therapies -- 8.3.1 EMA Accelerated Review and Conditional Marketing Routes -- 8.3.2 EU Compassionate Use -- 8.3.3 Expedited Pathways in the US -- 8.3.4 Expanded Access and Emergency Use Authorization (EUA) -- 8.4 Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible -- 8.5 Animal Drugs for Minor Use and Minor Species -- 8.5.1 Conditional Approval -- 8.5.2 Indexing -- 8.5.3 Designation -- 8.6 Special Provisions to Facilitate Access to Drugs for Animal Treatment in the EU -- 8.7 Changes to an Authorised Drug -- 8.8 EU System for Processing Changes -- 8.8.1 Extension Applications -- 8.8.2 Major Variation (Type II) -- 8.8.3 Minor Variation (Type IA or IB) -- 8.9 Processing Changes in the US -- 8.9.1 Manufacturing Change Supplements -- 8.9.2 Major Changes -- 8.9.3 Moderate Changes -- 8.9.4 Minor Changes -- 8.10 Authorisation of Generic Drugs -- 8.10.1 EU Regulations -- 8.10.2 US Regulations -- 8.11 Biosimilars -- 8.11.1 EU Regulations -- 8.11.2 US Regulations -- 8.12 Reference Drug Exclusivity -- 8.13 Other Authorisation Procedures -- 8.13.1 Well‐Established Medical Use Products -- 8.13.2 Combination Products -- 8.13.3 Homeopathic Medicines -- 8.13.4 Traditional Herbal Medicines -- 8.13.5 US Regulation of OTC Drugs -- 8.14 Chapter Review -- 8.15 Further Reading -- Chapter 9 Medical Devices -- 9.1 Chapter Introduction -- 9.2 Regulatory Strategy for Medical Devices in the EU -- 9.2.1 Use of Standards to Establish Conformity -- 9.2.2 Classification of Devices -- 9.3 Regulatory Strategy for Medical Devices in the US -- 9.3.1 Classification of Devices -- 9.3.1.1 Class I -- 9.3.1.2 Class II -- 9.3.1.3 Class III -- 9.3.2 Classification of New Devices -- 9.4 Development of Devices -- 9.4.1 Design Controls -- 9.4.2 Design and Development Planning -- 9.4.3 Design Input -- 9.4.4 Design Output 9.4.5 Design Verification and Design Validation -- 9.4.6 Design Review -- 9.4.7 Risk Analysis -- 9.4.8 Design Changes -- 9.5 Chapter Review -- 9.6 Further Reading -- Chapter 10 Authorisation of Medical Devices -- 10.1 Chapter Introduction -- 10.2 Evaluation of Medical Devices in Europe -- 10.2.1 Clinical Evaluation -- 10.2.2 Clinical Investigations -- 10.2.3 Performance Evaluation of IVDs -- 10.2.4 Performance Studies of IVDs -- 10.3 Evaluation of Medical Devices in the US -- 10.3.1 Exempted Investigations -- 10.3.2 Abbreviated Requirement Investigations -- 10.3.3 IDE Investigations -- 10.3.4 Labelling of Devices for Investigational Use -- 10.4 Placing of Devices on the Market in the EU -- 10.4.1 Designation of Notified Bodies -- 10.4.2 Conformity Assessment Procedures -- 10.4.2.1 Conformity Assessment Based on a Quality Management System and Assessment of Technical Documentation -- 10.4.2.2 EU Type‐Examination -- 10.4.2.3 Production Quality Assurance -- 10.4.2.4 EU Verification -- 10.4.2.5 EU (Self) Declaration of Conformity -- 10.4.3 Technical Documentation -- 10.4.4 Labelling Requirements -- 10.4.5 Registration of Economic Operators and Devices -- 10.5 Placing of Devices on the Market in the US -- 10.5.1 510(k) Pre‐market Notification -- 10.5.2 Traditional 510(k) -- 10.5.3 Abbreviated 510(k) -- 10.5.4 Special 510(k) -- 10.5.5 De Novo 510(k) -- 10.5.6 Notification and Review Procedures -- 10.5.7 Pre‐market Approval (PMA) -- 10.5.8 Changes to a PMA‐Approved Device -- 10.5.9 Humanitarian Use Devices (HUDs) -- 10.5.10 Labelling of Devices -- 10.6 Chapter Review -- 10.7 Further Reading -- Chapter 11 Good Manufacturing Practice (GMP) -- 11.1 Chapter Introduction -- 11.2 Drug GMP Regulations and Guidance -- 11.3 Essential GMP Requirements -- 11.3.1 Quality Assurance System -- 11.3.2 Personnel -- 11.3.3 Premises and Equipment -- 11.3.4 Documentation 11.3.5 Production
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code="a">Newark</subfield><subfield code="b">John Wiley & Sons, Incorporated</subfield><subfield code="c">2023</subfield></datafield><datafield tag="264" ind1=" " ind2="4"><subfield code="c">©2024</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">1 Online-Ressource (333 Seiten)</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Description based on publisher supplied metadata and other sources</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">Cover -- Title Page -- Copyright -- Contents -- Chapter 1 The Aims and Structure of Regulations -- 1.1 Introduction -- 1.2 Purpose and Principles of Regulation -- 1.3 The Legal Framework for Regulation -- 1.3.1 National Legislative Process -- 1.3.2 EU Legislative Process -- 1.3.3 Working with Legal Texts -- 1.3.4 Guidance Documents -- 1.3.5 Pharmacopoeia -- 1.4 Basic Legislation -- 1.4.1 EU Legislation -- 1.4.2 US Legislation -- 1.5 Scope of the Legislation -- 1.6 Chapter Review -- 1.7 Further Reading -- Chapter 2 Regulatory Strategy -- 2.1 Chapter Introduction -- 2.2 Basic Regulatory Strategy -- 2.2.1 Product Development -- 2.2.2 Product Manufacture -- 2.2.3 Market Vigilance -- 2.3 Quality Assurance Systems -- 2.3.1 Personnel -- 2.3.2 Documentation -- 2.3.3 Facilities and Equipment -- 2.3.4 Corrective and Preventative Action -- 2.4 Validation -- 2.5 Regulatory Bodies -- 2.5.1 European Commission -- 2.5.2 The EMA -- 2.5.3 National Competent Authorities -- 2.5.4 Notified Bodies -- 2.5.5 The FDA -- 2.5.6 US Department of Agriculture (USDA) -- 2.5.7 Pharmacopoeia Authorities -- 2.6 International Harmonisation Bodies -- 2.7 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use -- 2.7.1 VICH -- 2.7.2 The International Medical Device Regulators Forum (IMDRF) -- 2.8 Pharmaceutical Inspection Cooperation Scheme (PICS) -- 2.9 The World Health Organisation (WHO) -- 2.10 Chapter Review -- 2.11 Further Reading -- Chapter 3 Drug Discovery, Classification and Early Stage Development -- 3.1 Chapter Introduction -- 3.2 Drug Categorisation -- 3.2.1 Prescription Status -- 3.2.2 Physical Properties -- 3.2.3 Mode of Action -- 3.2.4 Therapeutic Use -- 3.3 Drug Discovery -- 3.3.1 Target Discovery and Validation -- 3.3.2 Lead Discovery, Validation and Optimisation -- 3.4 Drug Development -- 3.4.1 Manufacture and Control</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">3.5 Drug Delivery -- 3.5.1 Location -- 3.5.2 Drug Characteristics -- 3.5.3 Speed and Duration of Therapeutic Effect -- 3.5.4 Stability -- 3.6 Chapter Review -- 3.7 Further Reading -- Chapter 4 Non‐clinical Studies -- 4.1 Chapter Introduction -- 4.2 Non‐clinical Study Objectives and Timing -- 4.3 Pharmacological Studies -- 4.3.1 Pharmacodynamic Studies -- 4.3.2 Pharmacokinetic/Toxicokinetic Studies -- 4.4 Bioavailability and Bioequivalence -- 4.5 Toxicology Studies -- 4.5.1 Toxicity Studies -- 4.5.2 Genotoxicity Studies -- 4.5.3 Carcinogenicity Studies -- 4.5.4 Reproductive Toxicology Studies -- 4.6 Chemistry, Manufacturing and Control Development (CMC) -- 4.7 Quality by Design (QbD) -- 4.8 Quality of Biotech Products -- 4.8.1 Stability Studies -- 4.9 Good Laboratory Practice (GLP) -- 4.10 Chapter Review -- 4.11 Further Reading -- Chapter 5 Clinical Trials -- 5.1 Chapter Introduction -- 5.2 Clinical Trials -- 5.2.1 Phase I Trials -- 5.2.2 Phase II Trials -- 5.2.3 Phase III Trials -- 5.3 Clinical Trial Design -- 5.4 Good Clinical Practice -- 5.5 Clinical Trials in the EU -- 5.5.1 Sponsor -- 5.5.2 Investigator's Brochure (IB) -- 5.5.3 Investigator -- 5.5.4 Trial Protocol -- 5.5.5 Investigational Medicinal Product Dossier (IMPD) -- 5.5.6 Informed Consent -- 5.5.7 Manufacture of Investigational Medicinal Product -- 5.5.8 Clinical Trial Authorisation -- 5.5.9 Independent Ethics Committee Opinion -- 5.5.10 Amendments to Clinical Trials -- 5.5.11 Case Report Forms (CRFs) -- 5.5.12 Adverse Event Reporting -- 5.5.13 Annual Safety Report -- 5.5.14 Monitoring of Trials -- 5.5.15 End of Trial -- 5.5.16 Trial Master File -- 5.6 Clinical Trials in the US -- 5.6.1 Investigational New Drug Application (IND) -- 5.6.2 Institutional Review Board (IRB) -- 5.6.3 Communication with the FDA -- 5.6.4 Labelling of Investigational Drugs</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">5.6.5 Registry of Clinical Trial Information -- 5.7 Chapter Review -- 5.8 Further Reading -- Chapter 6 Marketing Authorisation -- 6.1 Chapter Introduction -- 6.2 The Application Dossier -- 6.3 CTD -- 6.3.1 Module Structure -- 6.3.2 Module 3 - Quality -- 6.3.3 Drug Master Files -- 6.3.4 Module 4 - Non‐clinical Study Reports -- 6.3.5 Module 5 - Clinical Study Reports -- 6.3.6 Module 2 - Summaries -- 6.3.7 Module I - Region Specific -- 6.3.8 Module 1 - EU -- 6.3.9 Module 1 - US -- 6.4 Submission and Review Process in the EU -- 6.4.1 Union Authorisation -- 6.4.2 Scientific Evaluation Process -- 6.4.3 Decision Making Process -- 6.4.4 National Authorisations -- 6.4.5 Decentralised Procedure -- 6.4.6 Mutual Recognition Procedure -- 6.4.7 Plasma Master Files and Vaccine Antigen Master Files -- 6.5 Submission and Review Process in the US -- 6.6 Chapter Review -- 6.7 Further Reading -- Chapter 7 Authorisation of Veterinary Medicines -- 7.1 Chapter Introduction -- 7.2 Overview of Development Process for Veterinary Medicines -- 7.2.1 Pre‐clinical Studies -- 7.2.2 Clinical Trials -- 7.2.3 Good Clinical Practices -- 7.3 Authorisation of Clinical Trials in the EU -- 7.4 Authorisation of Clinical Trials in the US -- 7.5 Maximum Residue Limits (MRLs) -- 7.6 Authorisation of Veterinary Medicines in the EU -- 7.6.1 Applications to Establish MRLs -- 7.6.2 Review of Applications and Establishment of MRLs -- 7.6.3 Marketing Authorisations -- 7.6.4 Presentation of the Dossier -- 7.7 Approval of Veterinary Medicines in the US -- 7.7.1 New Animal Drug Application (NADA) -- 7.7.2 Approval of Veterinary Biological Products -- 7.8 Chapter Review -- 7.9 Further Reading -- Chapter 8 Variations to the Drug Authorisation Process -- 8.1 Chapter Introduction -- 8.2 Provisions in Support of Special Drug Applications -- 8.2.1 Orphan Drugs -- 8.2.2 Paediatric Applications</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">8.3 Accelerated Access to New Drug Therapies -- 8.3.1 EMA Accelerated Review and Conditional Marketing Routes -- 8.3.2 EU Compassionate Use -- 8.3.3 Expedited Pathways in the US -- 8.3.4 Expanded Access and Emergency Use Authorization (EUA) -- 8.4 Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible -- 8.5 Animal Drugs for Minor Use and Minor Species -- 8.5.1 Conditional Approval -- 8.5.2 Indexing -- 8.5.3 Designation -- 8.6 Special Provisions to Facilitate Access to Drugs for Animal Treatment in the EU -- 8.7 Changes to an Authorised Drug -- 8.8 EU System for Processing Changes -- 8.8.1 Extension Applications -- 8.8.2 Major Variation (Type II) -- 8.8.3 Minor Variation (Type IA or IB) -- 8.9 Processing Changes in the US -- 8.9.1 Manufacturing Change Supplements -- 8.9.2 Major Changes -- 8.9.3 Moderate Changes -- 8.9.4 Minor Changes -- 8.10 Authorisation of Generic Drugs -- 8.10.1 EU Regulations -- 8.10.2 US Regulations -- 8.11 Biosimilars -- 8.11.1 EU Regulations -- 8.11.2 US Regulations -- 8.12 Reference Drug Exclusivity -- 8.13 Other Authorisation Procedures -- 8.13.1 Well‐Established Medical Use Products -- 8.13.2 Combination Products -- 8.13.3 Homeopathic Medicines -- 8.13.4 Traditional Herbal Medicines -- 8.13.5 US Regulation of OTC Drugs -- 8.14 Chapter Review -- 8.15 Further Reading -- Chapter 9 Medical Devices -- 9.1 Chapter Introduction -- 9.2 Regulatory Strategy for Medical Devices in the EU -- 9.2.1 Use of Standards to Establish Conformity -- 9.2.2 Classification of Devices -- 9.3 Regulatory Strategy for Medical Devices in the US -- 9.3.1 Classification of Devices -- 9.3.1.1 Class I -- 9.3.1.2 Class II -- 9.3.1.3 Class III -- 9.3.2 Classification of New Devices -- 9.4 Development of Devices -- 9.4.1 Design Controls -- 9.4.2 Design and Development Planning -- 9.4.3 Design Input -- 9.4.4 Design Output</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">9.4.5 Design Verification and Design Validation -- 9.4.6 Design Review -- 9.4.7 Risk Analysis -- 9.4.8 Design Changes -- 9.5 Chapter Review -- 9.6 Further Reading -- Chapter 10 Authorisation of Medical Devices -- 10.1 Chapter Introduction -- 10.2 Evaluation of Medical Devices in Europe -- 10.2.1 Clinical Evaluation -- 10.2.2 Clinical Investigations -- 10.2.3 Performance Evaluation of IVDs -- 10.2.4 Performance Studies of IVDs -- 10.3 Evaluation of Medical Devices in the US -- 10.3.1 Exempted Investigations -- 10.3.2 Abbreviated Requirement Investigations -- 10.3.3 IDE Investigations -- 10.3.4 Labelling of Devices for Investigational Use -- 10.4 Placing of Devices on the Market in the EU -- 10.4.1 Designation of Notified Bodies -- 10.4.2 Conformity Assessment Procedures -- 10.4.2.1 Conformity Assessment Based on a Quality Management System and Assessment of Technical Documentation -- 10.4.2.2 EU Type‐Examination -- 10.4.2.3 Production Quality Assurance -- 10.4.2.4 EU Verification -- 10.4.2.5 EU (Self) Declaration of Conformity -- 10.4.3 Technical Documentation -- 10.4.4 Labelling Requirements -- 10.4.5 Registration of Economic Operators and Devices -- 10.5 Placing of Devices on the Market in the US -- 10.5.1 510(k) Pre‐market Notification -- 10.5.2 Traditional 510(k) -- 10.5.3 Abbreviated 510(k) 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index_date	2024-07-03T23:05:38Z
indexdate	2025-01-10T17:14:07Z
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language	English
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spelling	Tobin, John J. Verfasser aut Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices 2nd ed Newark John Wiley & Sons, Incorporated 2023 ©2024 1 Online-Ressource (333 Seiten) txt rdacontent c rdamedia cr rdacarrier Description based on publisher supplied metadata and other sources Cover -- Title Page -- Copyright -- Contents -- Chapter 1 The Aims and Structure of Regulations -- 1.1 Introduction -- 1.2 Purpose and Principles of Regulation -- 1.3 The Legal Framework for Regulation -- 1.3.1 National Legislative Process -- 1.3.2 EU Legislative Process -- 1.3.3 Working with Legal Texts -- 1.3.4 Guidance Documents -- 1.3.5 Pharmacopoeia -- 1.4 Basic Legislation -- 1.4.1 EU Legislation -- 1.4.2 US Legislation -- 1.5 Scope of the Legislation -- 1.6 Chapter Review -- 1.7 Further Reading -- Chapter 2 Regulatory Strategy -- 2.1 Chapter Introduction -- 2.2 Basic Regulatory Strategy -- 2.2.1 Product Development -- 2.2.2 Product Manufacture -- 2.2.3 Market Vigilance -- 2.3 Quality Assurance Systems -- 2.3.1 Personnel -- 2.3.2 Documentation -- 2.3.3 Facilities and Equipment -- 2.3.4 Corrective and Preventative Action -- 2.4 Validation -- 2.5 Regulatory Bodies -- 2.5.1 European Commission -- 2.5.2 The EMA -- 2.5.3 National Competent Authorities -- 2.5.4 Notified Bodies -- 2.5.5 The FDA -- 2.5.6 US Department of Agriculture (USDA) -- 2.5.7 Pharmacopoeia Authorities -- 2.6 International Harmonisation Bodies -- 2.7 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use -- 2.7.1 VICH -- 2.7.2 The International Medical Device Regulators Forum (IMDRF) -- 2.8 Pharmaceutical Inspection Cooperation Scheme (PICS) -- 2.9 The World Health Organisation (WHO) -- 2.10 Chapter Review -- 2.11 Further Reading -- Chapter 3 Drug Discovery, Classification and Early Stage Development -- 3.1 Chapter Introduction -- 3.2 Drug Categorisation -- 3.2.1 Prescription Status -- 3.2.2 Physical Properties -- 3.2.3 Mode of Action -- 3.2.4 Therapeutic Use -- 3.3 Drug Discovery -- 3.3.1 Target Discovery and Validation -- 3.3.2 Lead Discovery, Validation and Optimisation -- 3.4 Drug Development -- 3.4.1 Manufacture and Control 3.5 Drug Delivery -- 3.5.1 Location -- 3.5.2 Drug Characteristics -- 3.5.3 Speed and Duration of Therapeutic Effect -- 3.5.4 Stability -- 3.6 Chapter Review -- 3.7 Further Reading -- Chapter 4 Non‐clinical Studies -- 4.1 Chapter Introduction -- 4.2 Non‐clinical Study Objectives and Timing -- 4.3 Pharmacological Studies -- 4.3.1 Pharmacodynamic Studies -- 4.3.2 Pharmacokinetic/Toxicokinetic Studies -- 4.4 Bioavailability and Bioequivalence -- 4.5 Toxicology Studies -- 4.5.1 Toxicity Studies -- 4.5.2 Genotoxicity Studies -- 4.5.3 Carcinogenicity Studies -- 4.5.4 Reproductive Toxicology Studies -- 4.6 Chemistry, Manufacturing and Control Development (CMC) -- 4.7 Quality by Design (QbD) -- 4.8 Quality of Biotech Products -- 4.8.1 Stability Studies -- 4.9 Good Laboratory Practice (GLP) -- 4.10 Chapter Review -- 4.11 Further Reading -- Chapter 5 Clinical Trials -- 5.1 Chapter Introduction -- 5.2 Clinical Trials -- 5.2.1 Phase I Trials -- 5.2.2 Phase II Trials -- 5.2.3 Phase III Trials -- 5.3 Clinical Trial Design -- 5.4 Good Clinical Practice -- 5.5 Clinical Trials in the EU -- 5.5.1 Sponsor -- 5.5.2 Investigator's Brochure (IB) -- 5.5.3 Investigator -- 5.5.4 Trial Protocol -- 5.5.5 Investigational Medicinal Product Dossier (IMPD) -- 5.5.6 Informed Consent -- 5.5.7 Manufacture of Investigational Medicinal Product -- 5.5.8 Clinical Trial Authorisation -- 5.5.9 Independent Ethics Committee Opinion -- 5.5.10 Amendments to Clinical Trials -- 5.5.11 Case Report Forms (CRFs) -- 5.5.12 Adverse Event Reporting -- 5.5.13 Annual Safety Report -- 5.5.14 Monitoring of Trials -- 5.5.15 End of Trial -- 5.5.16 Trial Master File -- 5.6 Clinical Trials in the US -- 5.6.1 Investigational New Drug Application (IND) -- 5.6.2 Institutional Review Board (IRB) -- 5.6.3 Communication with the FDA -- 5.6.4 Labelling of Investigational Drugs 5.6.5 Registry of Clinical Trial Information -- 5.7 Chapter Review -- 5.8 Further Reading -- Chapter 6 Marketing Authorisation -- 6.1 Chapter Introduction -- 6.2 The Application Dossier -- 6.3 CTD -- 6.3.1 Module Structure -- 6.3.2 Module 3 - Quality -- 6.3.3 Drug Master Files -- 6.3.4 Module 4 - Non‐clinical Study Reports -- 6.3.5 Module 5 - Clinical Study Reports -- 6.3.6 Module 2 - Summaries -- 6.3.7 Module I - Region Specific -- 6.3.8 Module 1 - EU -- 6.3.9 Module 1 - US -- 6.4 Submission and Review Process in the EU -- 6.4.1 Union Authorisation -- 6.4.2 Scientific Evaluation Process -- 6.4.3 Decision Making Process -- 6.4.4 National Authorisations -- 6.4.5 Decentralised Procedure -- 6.4.6 Mutual Recognition Procedure -- 6.4.7 Plasma Master Files and Vaccine Antigen Master Files -- 6.5 Submission and Review Process in the US -- 6.6 Chapter Review -- 6.7 Further Reading -- Chapter 7 Authorisation of Veterinary Medicines -- 7.1 Chapter Introduction -- 7.2 Overview of Development Process for Veterinary Medicines -- 7.2.1 Pre‐clinical Studies -- 7.2.2 Clinical Trials -- 7.2.3 Good Clinical Practices -- 7.3 Authorisation of Clinical Trials in the EU -- 7.4 Authorisation of Clinical Trials in the US -- 7.5 Maximum Residue Limits (MRLs) -- 7.6 Authorisation of Veterinary Medicines in the EU -- 7.6.1 Applications to Establish MRLs -- 7.6.2 Review of Applications and Establishment of MRLs -- 7.6.3 Marketing Authorisations -- 7.6.4 Presentation of the Dossier -- 7.7 Approval of Veterinary Medicines in the US -- 7.7.1 New Animal Drug Application (NADA) -- 7.7.2 Approval of Veterinary Biological Products -- 7.8 Chapter Review -- 7.9 Further Reading -- Chapter 8 Variations to the Drug Authorisation Process -- 8.1 Chapter Introduction -- 8.2 Provisions in Support of Special Drug Applications -- 8.2.1 Orphan Drugs -- 8.2.2 Paediatric Applications 8.3 Accelerated Access to New Drug Therapies -- 8.3.1 EMA Accelerated Review and Conditional Marketing Routes -- 8.3.2 EU Compassionate Use -- 8.3.3 Expedited Pathways in the US -- 8.3.4 Expanded Access and Emergency Use Authorization (EUA) -- 8.4 Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible -- 8.5 Animal Drugs for Minor Use and Minor Species -- 8.5.1 Conditional Approval -- 8.5.2 Indexing -- 8.5.3 Designation -- 8.6 Special Provisions to Facilitate Access to Drugs for Animal Treatment in the EU -- 8.7 Changes to an Authorised Drug -- 8.8 EU System for Processing Changes -- 8.8.1 Extension Applications -- 8.8.2 Major Variation (Type II) -- 8.8.3 Minor Variation (Type IA or IB) -- 8.9 Processing Changes in the US -- 8.9.1 Manufacturing Change Supplements -- 8.9.2 Major Changes -- 8.9.3 Moderate Changes -- 8.9.4 Minor Changes -- 8.10 Authorisation of Generic Drugs -- 8.10.1 EU Regulations -- 8.10.2 US Regulations -- 8.11 Biosimilars -- 8.11.1 EU Regulations -- 8.11.2 US Regulations -- 8.12 Reference Drug Exclusivity -- 8.13 Other Authorisation Procedures -- 8.13.1 Well‐Established Medical Use Products -- 8.13.2 Combination Products -- 8.13.3 Homeopathic Medicines -- 8.13.4 Traditional Herbal Medicines -- 8.13.5 US Regulation of OTC Drugs -- 8.14 Chapter Review -- 8.15 Further Reading -- Chapter 9 Medical Devices -- 9.1 Chapter Introduction -- 9.2 Regulatory Strategy for Medical Devices in the EU -- 9.2.1 Use of Standards to Establish Conformity -- 9.2.2 Classification of Devices -- 9.3 Regulatory Strategy for Medical Devices in the US -- 9.3.1 Classification of Devices -- 9.3.1.1 Class I -- 9.3.1.2 Class II -- 9.3.1.3 Class III -- 9.3.2 Classification of New Devices -- 9.4 Development of Devices -- 9.4.1 Design Controls -- 9.4.2 Design and Development Planning -- 9.4.3 Design Input -- 9.4.4 Design Output 9.4.5 Design Verification and Design Validation -- 9.4.6 Design Review -- 9.4.7 Risk Analysis -- 9.4.8 Design Changes -- 9.5 Chapter Review -- 9.6 Further Reading -- Chapter 10 Authorisation of Medical Devices -- 10.1 Chapter Introduction -- 10.2 Evaluation of Medical Devices in Europe -- 10.2.1 Clinical Evaluation -- 10.2.2 Clinical Investigations -- 10.2.3 Performance Evaluation of IVDs -- 10.2.4 Performance Studies of IVDs -- 10.3 Evaluation of Medical Devices in the US -- 10.3.1 Exempted Investigations -- 10.3.2 Abbreviated Requirement Investigations -- 10.3.3 IDE Investigations -- 10.3.4 Labelling of Devices for Investigational Use -- 10.4 Placing of Devices on the Market in the EU -- 10.4.1 Designation of Notified Bodies -- 10.4.2 Conformity Assessment Procedures -- 10.4.2.1 Conformity Assessment Based on a Quality Management System and Assessment of Technical Documentation -- 10.4.2.2 EU Type‐Examination -- 10.4.2.3 Production Quality Assurance -- 10.4.2.4 EU Verification -- 10.4.2.5 EU (Self) Declaration of Conformity -- 10.4.3 Technical Documentation -- 10.4.4 Labelling Requirements -- 10.4.5 Registration of Economic Operators and Devices -- 10.5 Placing of Devices on the Market in the US -- 10.5.1 510(k) Pre‐market Notification -- 10.5.2 Traditional 510(k) -- 10.5.3 Abbreviated 510(k) -- 10.5.4 Special 510(k) -- 10.5.5 De Novo 510(k) -- 10.5.6 Notification and Review Procedures -- 10.5.7 Pre‐market Approval (PMA) -- 10.5.8 Changes to a PMA‐Approved Device -- 10.5.9 Humanitarian Use Devices (HUDs) -- 10.5.10 Labelling of Devices -- 10.6 Chapter Review -- 10.7 Further Reading -- Chapter 11 Good Manufacturing Practice (GMP) -- 11.1 Chapter Introduction -- 11.2 Drug GMP Regulations and Guidance -- 11.3 Essential GMP Requirements -- 11.3.1 Quality Assurance System -- 11.3.2 Personnel -- 11.3.3 Premises and Equipment -- 11.3.4 Documentation 11.3.5 Production Europäische Union (DE-588)5098525-5 gnd rswk-swf Drugs-Law and legislation Pharmacy-Law and legislation Arzneimittelrecht (DE-588)4003139-1 gnd rswk-swf USA (DE-588)4078704-7 gnd rswk-swf USA (DE-588)4078704-7 g Europäische Union (DE-588)5098525-5 b Arzneimittelrecht (DE-588)4003139-1 s DE-604 Walsh, Gary Sonstige oth Erscheint auch als Druck-Ausgabe Tobin, John J. Medical Product Regulatory Affairs Newark : John Wiley & Sons, Incorporated,c2023 9783527333264
spellingShingle	Tobin, John J. Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices Cover -- Title Page -- Copyright -- Contents -- Chapter 1 The Aims and Structure of Regulations -- 1.1 Introduction -- 1.2 Purpose and Principles of Regulation -- 1.3 The Legal Framework for Regulation -- 1.3.1 National Legislative Process -- 1.3.2 EU Legislative Process -- 1.3.3 Working with Legal Texts -- 1.3.4 Guidance Documents -- 1.3.5 Pharmacopoeia -- 1.4 Basic Legislation -- 1.4.1 EU Legislation -- 1.4.2 US Legislation -- 1.5 Scope of the Legislation -- 1.6 Chapter Review -- 1.7 Further Reading -- Chapter 2 Regulatory Strategy -- 2.1 Chapter Introduction -- 2.2 Basic Regulatory Strategy -- 2.2.1 Product Development -- 2.2.2 Product Manufacture -- 2.2.3 Market Vigilance -- 2.3 Quality Assurance Systems -- 2.3.1 Personnel -- 2.3.2 Documentation -- 2.3.3 Facilities and Equipment -- 2.3.4 Corrective and Preventative Action -- 2.4 Validation -- 2.5 Regulatory Bodies -- 2.5.1 European Commission -- 2.5.2 The EMA -- 2.5.3 National Competent Authorities -- 2.5.4 Notified Bodies -- 2.5.5 The FDA -- 2.5.6 US Department of Agriculture (USDA) -- 2.5.7 Pharmacopoeia Authorities -- 2.6 International Harmonisation Bodies -- 2.7 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use -- 2.7.1 VICH -- 2.7.2 The International Medical Device Regulators Forum (IMDRF) -- 2.8 Pharmaceutical Inspection Cooperation Scheme (PICS) -- 2.9 The World Health Organisation (WHO) -- 2.10 Chapter Review -- 2.11 Further Reading -- Chapter 3 Drug Discovery, Classification and Early Stage Development -- 3.1 Chapter Introduction -- 3.2 Drug Categorisation -- 3.2.1 Prescription Status -- 3.2.2 Physical Properties -- 3.2.3 Mode of Action -- 3.2.4 Therapeutic Use -- 3.3 Drug Discovery -- 3.3.1 Target Discovery and Validation -- 3.3.2 Lead Discovery, Validation and Optimisation -- 3.4 Drug Development -- 3.4.1 Manufacture and Control 3.5 Drug Delivery -- 3.5.1 Location -- 3.5.2 Drug Characteristics -- 3.5.3 Speed and Duration of Therapeutic Effect -- 3.5.4 Stability -- 3.6 Chapter Review -- 3.7 Further Reading -- Chapter 4 Non‐clinical Studies -- 4.1 Chapter Introduction -- 4.2 Non‐clinical Study Objectives and Timing -- 4.3 Pharmacological Studies -- 4.3.1 Pharmacodynamic Studies -- 4.3.2 Pharmacokinetic/Toxicokinetic Studies -- 4.4 Bioavailability and Bioequivalence -- 4.5 Toxicology Studies -- 4.5.1 Toxicity Studies -- 4.5.2 Genotoxicity Studies -- 4.5.3 Carcinogenicity Studies -- 4.5.4 Reproductive Toxicology Studies -- 4.6 Chemistry, Manufacturing and Control Development (CMC) -- 4.7 Quality by Design (QbD) -- 4.8 Quality of Biotech Products -- 4.8.1 Stability Studies -- 4.9 Good Laboratory Practice (GLP) -- 4.10 Chapter Review -- 4.11 Further Reading -- Chapter 5 Clinical Trials -- 5.1 Chapter Introduction -- 5.2 Clinical Trials -- 5.2.1 Phase I Trials -- 5.2.2 Phase II Trials -- 5.2.3 Phase III Trials -- 5.3 Clinical Trial Design -- 5.4 Good Clinical Practice -- 5.5 Clinical Trials in the EU -- 5.5.1 Sponsor -- 5.5.2 Investigator's Brochure (IB) -- 5.5.3 Investigator -- 5.5.4 Trial Protocol -- 5.5.5 Investigational Medicinal Product Dossier (IMPD) -- 5.5.6 Informed Consent -- 5.5.7 Manufacture of Investigational Medicinal Product -- 5.5.8 Clinical Trial Authorisation -- 5.5.9 Independent Ethics Committee Opinion -- 5.5.10 Amendments to Clinical Trials -- 5.5.11 Case Report Forms (CRFs) -- 5.5.12 Adverse Event Reporting -- 5.5.13 Annual Safety Report -- 5.5.14 Monitoring of Trials -- 5.5.15 End of Trial -- 5.5.16 Trial Master File -- 5.6 Clinical Trials in the US -- 5.6.1 Investigational New Drug Application (IND) -- 5.6.2 Institutional Review Board (IRB) -- 5.6.3 Communication with the FDA -- 5.6.4 Labelling of Investigational Drugs 5.6.5 Registry of Clinical Trial Information -- 5.7 Chapter Review -- 5.8 Further Reading -- Chapter 6 Marketing Authorisation -- 6.1 Chapter Introduction -- 6.2 The Application Dossier -- 6.3 CTD -- 6.3.1 Module Structure -- 6.3.2 Module 3 - Quality -- 6.3.3 Drug Master Files -- 6.3.4 Module 4 - Non‐clinical Study Reports -- 6.3.5 Module 5 - Clinical Study Reports -- 6.3.6 Module 2 - Summaries -- 6.3.7 Module I - Region Specific -- 6.3.8 Module 1 - EU -- 6.3.9 Module 1 - US -- 6.4 Submission and Review Process in the EU -- 6.4.1 Union Authorisation -- 6.4.2 Scientific Evaluation Process -- 6.4.3 Decision Making Process -- 6.4.4 National Authorisations -- 6.4.5 Decentralised Procedure -- 6.4.6 Mutual Recognition Procedure -- 6.4.7 Plasma Master Files and Vaccine Antigen Master Files -- 6.5 Submission and Review Process in the US -- 6.6 Chapter Review -- 6.7 Further Reading -- Chapter 7 Authorisation of Veterinary Medicines -- 7.1 Chapter Introduction -- 7.2 Overview of Development Process for Veterinary Medicines -- 7.2.1 Pre‐clinical Studies -- 7.2.2 Clinical Trials -- 7.2.3 Good Clinical Practices -- 7.3 Authorisation of Clinical Trials in the EU -- 7.4 Authorisation of Clinical Trials in the US -- 7.5 Maximum Residue Limits (MRLs) -- 7.6 Authorisation of Veterinary Medicines in the EU -- 7.6.1 Applications to Establish MRLs -- 7.6.2 Review of Applications and Establishment of MRLs -- 7.6.3 Marketing Authorisations -- 7.6.4 Presentation of the Dossier -- 7.7 Approval of Veterinary Medicines in the US -- 7.7.1 New Animal Drug Application (NADA) -- 7.7.2 Approval of Veterinary Biological Products -- 7.8 Chapter Review -- 7.9 Further Reading -- Chapter 8 Variations to the Drug Authorisation Process -- 8.1 Chapter Introduction -- 8.2 Provisions in Support of Special Drug Applications -- 8.2.1 Orphan Drugs -- 8.2.2 Paediatric Applications 8.3 Accelerated Access to New Drug Therapies -- 8.3.1 EMA Accelerated Review and Conditional Marketing Routes -- 8.3.2 EU Compassionate Use -- 8.3.3 Expedited Pathways in the US -- 8.3.4 Expanded Access and Emergency Use Authorization (EUA) -- 8.4 Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible -- 8.5 Animal Drugs for Minor Use and Minor Species -- 8.5.1 Conditional Approval -- 8.5.2 Indexing -- 8.5.3 Designation -- 8.6 Special Provisions to Facilitate Access to Drugs for Animal Treatment in the EU -- 8.7 Changes to an Authorised Drug -- 8.8 EU System for Processing Changes -- 8.8.1 Extension Applications -- 8.8.2 Major Variation (Type II) -- 8.8.3 Minor Variation (Type IA or IB) -- 8.9 Processing Changes in the US -- 8.9.1 Manufacturing Change Supplements -- 8.9.2 Major Changes -- 8.9.3 Moderate Changes -- 8.9.4 Minor Changes -- 8.10 Authorisation of Generic Drugs -- 8.10.1 EU Regulations -- 8.10.2 US Regulations -- 8.11 Biosimilars -- 8.11.1 EU Regulations -- 8.11.2 US Regulations -- 8.12 Reference Drug Exclusivity -- 8.13 Other Authorisation Procedures -- 8.13.1 Well‐Established Medical Use Products -- 8.13.2 Combination Products -- 8.13.3 Homeopathic Medicines -- 8.13.4 Traditional Herbal Medicines -- 8.13.5 US Regulation of OTC Drugs -- 8.14 Chapter Review -- 8.15 Further Reading -- Chapter 9 Medical Devices -- 9.1 Chapter Introduction -- 9.2 Regulatory Strategy for Medical Devices in the EU -- 9.2.1 Use of Standards to Establish Conformity -- 9.2.2 Classification of Devices -- 9.3 Regulatory Strategy for Medical Devices in the US -- 9.3.1 Classification of Devices -- 9.3.1.1 Class I -- 9.3.1.2 Class II -- 9.3.1.3 Class III -- 9.3.2 Classification of New Devices -- 9.4 Development of Devices -- 9.4.1 Design Controls -- 9.4.2 Design and Development Planning -- 9.4.3 Design Input -- 9.4.4 Design Output 9.4.5 Design Verification and Design Validation -- 9.4.6 Design Review -- 9.4.7 Risk Analysis -- 9.4.8 Design Changes -- 9.5 Chapter Review -- 9.6 Further Reading -- Chapter 10 Authorisation of Medical Devices -- 10.1 Chapter Introduction -- 10.2 Evaluation of Medical Devices in Europe -- 10.2.1 Clinical Evaluation -- 10.2.2 Clinical Investigations -- 10.2.3 Performance Evaluation of IVDs -- 10.2.4 Performance Studies of IVDs -- 10.3 Evaluation of Medical Devices in the US -- 10.3.1 Exempted Investigations -- 10.3.2 Abbreviated Requirement Investigations -- 10.3.3 IDE Investigations -- 10.3.4 Labelling of Devices for Investigational Use -- 10.4 Placing of Devices on the Market in the EU -- 10.4.1 Designation of Notified Bodies -- 10.4.2 Conformity Assessment Procedures -- 10.4.2.1 Conformity Assessment Based on a Quality Management System and Assessment of Technical Documentation -- 10.4.2.2 EU Type‐Examination -- 10.4.2.3 Production Quality Assurance -- 10.4.2.4 EU Verification -- 10.4.2.5 EU (Self) Declaration of Conformity -- 10.4.3 Technical Documentation -- 10.4.4 Labelling Requirements -- 10.4.5 Registration of Economic Operators and Devices -- 10.5 Placing of Devices on the Market in the US -- 10.5.1 510(k) Pre‐market Notification -- 10.5.2 Traditional 510(k) -- 10.5.3 Abbreviated 510(k) -- 10.5.4 Special 510(k) -- 10.5.5 De Novo 510(k) -- 10.5.6 Notification and Review Procedures -- 10.5.7 Pre‐market Approval (PMA) -- 10.5.8 Changes to a PMA‐Approved Device -- 10.5.9 Humanitarian Use Devices (HUDs) -- 10.5.10 Labelling of Devices -- 10.6 Chapter Review -- 10.7 Further Reading -- Chapter 11 Good Manufacturing Practice (GMP) -- 11.1 Chapter Introduction -- 11.2 Drug GMP Regulations and Guidance -- 11.3 Essential GMP Requirements -- 11.3.1 Quality Assurance System -- 11.3.2 Personnel -- 11.3.3 Premises and Equipment -- 11.3.4 Documentation 11.3.5 Production Europäische Union (DE-588)5098525-5 gnd Drugs-Law and legislation Pharmacy-Law and legislation Arzneimittelrecht (DE-588)4003139-1 gnd
subject_GND	(DE-588)5098525-5 (DE-588)4003139-1 (DE-588)4078704-7
title	Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices
title_auth	Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices
title_exact_search	Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices
title_exact_search_txtP	Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices
title_full	Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices
title_fullStr	Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices
title_full_unstemmed	Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices
title_short	Medical Product Regulatory Affairs
title_sort	medical product regulatory affairs pharmaceuticals diagnostics medical devices
title_sub	Pharmaceuticals, Diagnostics, Medical Devices
topic	Europäische Union (DE-588)5098525-5 gnd Drugs-Law and legislation Pharmacy-Law and legislation Arzneimittelrecht (DE-588)4003139-1 gnd
topic_facet	Europäische Union Drugs-Law and legislation Pharmacy-Law and legislation Arzneimittelrecht USA
work_keys_str_mv	AT tobinjohnj medicalproductregulatoryaffairspharmaceuticalsdiagnosticsmedicaldevices AT walshgary medicalproductregulatoryaffairspharmaceuticalsdiagnosticsmedicaldevices

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