Medical Product Regulatory Affairs

Pharmaceuticals, Diagnostics, Medical Devices

Inbunden, Engelska, 2023

Av John J. Tobin, Gary Walsh, Ireland) Tobin, John J. (ChemHaz Solutions, Clare County, Ireland) Walsh, Gary (ChemHaz Solutions, Clare County

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Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeiaRegulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentationDrug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and deliveryNon-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalenceClinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communicationsThe wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

Produktinformation

Utgivningsdatum2023-10-11
Mått20 x 240 x 170 mm
Vikt680 g
FormatInbunden
SpråkEngelska
Antal sidor336
Upplaga2
FörlagWiley-VCH Verlag GmbH
ISBN9783527333264

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Offentlig förvaltning inom Juridik
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Farmakologi inom Medicin
Biokemisk teknik inom Naturvetenskap och teknik

John J. Tobin worked for many years and in various capacities within Olympus diagnostica GmbH, a company that employed several 100 people to develop and manufacture in vitro diagnostic reagents. Gary Walsh is chair of industrial biotechnology at the University of Limerick, Ireland. He has direct industrial experience within the pharmaceutical and diagnostic industries as well as extensive teaching and research interests in the pharmaceutical and biotechnology arena.

1 The Aims and Structure of Regulations 11.1 Introduction 11.2 Purpose and Principles of Regulation 11.3 The Legal Framework for Regulation 31.3.1 National Legislative Process 31.3.2 EU Legislative Process 41.3.3 Working with Legal Texts 61.3.4 Guidance Documents 71.3.5 Pharmacopoeia 71.4 Basic Legislation 71.4.1 EU Legislation 71.4.2 US Legislation 121.5 Scope of the Legislation 151.6 Chapter Review 201.7 Further Reading 212 Regulatory Strategy 232.1 Chapter Introduction 232.2 Basic Regulatory Strategy 232.2.1 Product Development 232.2.2 Product Manufacture 232.2.3 Market Vigilance 242.3 Quality Assurance Systems 252.3.1 Personnel 252.3.2 Documentation 252.3.3 Facilities and Equipment 262.3.4 Corrective and Preventative Action 272.4 Validation 272.5 Regulatory Bodies 292.5.1 European Commission 292.5.2 The EMA 302.5.3 National Competent Authorities 322.5.4 Notified Bodies 342.5.5 The FDA 352.5.6 US Department of Agriculture (USDA) 392.5.7 Pharmacopoeia Authorities 392.6 International Harmonisation Bodies 402.7 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 412.7.1 VICH 432.7.2 The International Medical Device Regulators Forum (IMDRF) 432.8 Pharmaceutical Inspection Cooperation Scheme (PICS) 442.9 The World Health Organisation (WHO) 452.10 Chapter Review 452.11 Further Reading 463 Drug Discovery, Classification and Early Stage Development 473.1 Chapter Introduction 473.2 Drug Categorisation 473.2.1 Prescription Status 473.2.2 Physical Properties 483.2.3 Mode of Action 483.2.4 Therapeutic Use 493.3 Drug Discovery 513.3.1 Target Discovery and Validation 523.3.2 Lead Discovery, Validation and Optimisation 573.4 Drug Development 583.4.1 Manufacture and Control 593.5 Drug Delivery 593.5.1 Location 603.5.2 Drug Characteristics 603.5.3 Speed and Duration of Therapeutic Effect 623.5.4 Stability 633.6 Chapter Review 633.7 Further Reading 634 Non-clinical Studies 654.1 Chapter Introduction 654.2 Non-clinical Study Objectives and Timing 654.3 Pharmacological Studies 694.3.1 Pharmacodynamic Studies 704.3.2 Pharmacokinetic/Toxicokinetic Studies 724.4 Bioavailability and Bioequivalence 734.5 Toxicology Studies 744.5.1 Toxicity Studies 744.5.2 Genotoxicity Studies 754.5.3 Carcinogenicity Studies 764.5.4 Reproductive Toxicology Studies 764.6 Chemistry, Manufacturing and Control Development (CMC) 774.7 Quality by Design (QbD) 774.8 Quality of Biotech Products 784.8.1 Stability Studies 784.9 Good Laboratory Practice (GLP) 784.10 Chapter Review 804.11 Further Reading 835 Clinical Trials 855.1 Chapter Introduction 855.2 Clinical Trials 855.2.1 Phase I Trials 865.2.2 Phase II Trials 865.2.3 Phase III Trials 875.3 Clinical Trial Design 885.4 Good Clinical Practice 905.5 Clinical Trials in the EU 905.5.1 Sponsor 935.5.2 Investigator’s Brochure (IB) 935.5.3 Investigator 945.5.4 Trial Protocol 945.5.5 Investigational Medicinal Product Dossier (IMPD) 945.5.6 Informed Consent 945.5.7 Manufacture of Investigational Medicinal Product 955.5.8 Clinical Trial Authorisation 955.5.9 Independent Ethics Committee Opinion 965.5.10 Amendments to Clinical Trials 975.5.11 Case Report Forms (CRFs) 975.5.12 Adverse Event Reporting 975.5.13 Annual Safety Report 985.5.14 Monitoring of Trials 985.5.15 End of Trial 985.5.16 Trial Master File 985.6 Clinical Trials in the US 1005.6.1 Investigational New Drug Application (IND) 1005.6.2 Institutional Review Board (IRB) 1035.6.3 Communication with the FDA 1045.6.4 Labelling of Investigational Drugs 1055.6.5 Registry of Clinical Trial Information 1055.7 Chapter Review 1055.8 Further Reading 1066 Marketing Authorisation 1096.1 Chapter Introduction 1096.2 The Application Dossier 1096.3 CTD 1106.3.1 Module Structure 1126.3.2 Module 3 – Quality 1136.3.3 Drug Master Files 1166.3.4 Module 4 – Non-clinical Study Reports 1166.3.5 Module 5 – Clinical Study Reports 1166.3.6 Module 2 – Summaries 1186.3.7 Module I – Region Specific 1206.3.8 Module 1 – EU 1216.3.9 Module 1 – US 1236.4 Submission and Review Process in the EU 1276.4.1 Union Authorisation 1286.4.2 Scientific Evaluation Process 1296.4.3 Decision Making Process 1306.4.4 National Authorisations 1326.4.5 Decentralised Procedure 1326.4.6 Mutual Recognition Procedure 1346.4.7 Plasma Master Files and Vaccine Antigen Master Files 1346.5 Submission and Review Process in the US 1346.6 Chapter Review 1386.7 Further Reading 1387 Authorisation of Veterinary Medicines 1397.1 Chapter Introduction 1397.2 Overview of Development Process for Veterinary Medicines 1397.2.1 Pre-clinical Studies 1407.2.2 Clinical Trials 1417.2.3 Good Clinical Practices 1417.3 Authorisation of Clinical Trials in the EU 1457.4 Authorisation of Clinical Trials in the US 1467.5 Maximum Residue Limits (MRLs) 1477.6 Authorisation of Veterinary Medicines in the EU 1497.6.1 Applications to Establish MRLs 1497.6.2 Review of Applications and Establishment of MRLs 1527.6.3 Marketing Authorisations 1567.6.4 Presentation of the Dossier 1567.7 Approval of Veterinary Medicines in the US 1587.7.1 New Animal Drug Application (NADA) 1587.7.2 Approval of Veterinary Biological Products 1637.8 Chapter Review 1647.9 Further Reading 1648 Variations to the Drug Authorisation Process 1658.1 Chapter Introduction 1658.2 Provisions in Support of Special Drug Applications 1658.2.1 Orphan Drugs 1658.2.2 Paediatric Applications 1678.3 Accelerated Access to New Drug Therapies 1708.3.1 EMA Accelerated Review and Conditional Marketing Routes 1708.3.2 EU Compassionate Use 1718.3.3 Expedited Pathways in the US 1718.3.4 Expanded Access and Emergency Use Authorization (EUA) 1748.4 Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible 1758.5 Animal Drugs for Minor Use and Minor Species 1768.5.1 Conditional Approval 1768.5.2 Indexing 1768.5.3 Designation 1768.6 Special Provisions to Facilitate Access to Drugs for Animal Treatment in the EU 1778.7 Changes to an Authorised Drug 1778.8 EU System for Processing Changes 1778.8.1 Extension Applications 1788.8.2 Major Variation (Type II) 1788.8.3 Minor Variation (Type IA or IB) 1798.9 Processing Changes in the US 1798.9.1 Manufacturing Change Supplements 1808.9.2 Major Changes 1808.9.3 Moderate Changes 1808.9.4 Minor Changes 1818.10 Authorisation of Generic Drugs 1818.10.1 EU Regulations 1818.10.2 US Regulations 1828.11 Biosimilars 1838.11.1 EU Regulations 1848.11.2 US Regulations 1858.12 Reference Drug Exclusivity 1898.13 Other Authorisation Procedures 1918.13.1 Well-Established Medical Use Products 1918.13.2 Combination Products 1918.13.3 Homeopathic Medicines 1928.13.4 Traditional Herbal Medicines 1928.13.5 US Regulation of OTC Drugs 1938.14 Chapter Review 1938.15 Further Reading 1949 Medical Devices 1959.1 Chapter Introduction 1959.2 Regulatory Strategy for Medical Devices in the EU 1959.2.1 Use of Standards to Establish Conformity 2009.2.2 Classification of Devices 2019.3 Regulatory Strategy for Medical Devices in the US 2109.3.1 Classification of Devices 2109.3.1.1 Class I 2119.3.1.2 Class II 2119.3.1.3 Class III 2119.3.2 Classification of New Devices 2129.4 Development of Devices 2129.4.1 Design Controls 2139.4.2 Design and Development Planning 2149.4.3 Design Input 2149.4.4 Design Output 2169.4.5 Design Verification and Design Validation 2169.4.6 Design Review 2179.4.7 Risk Analysis 2189.4.8 Design Changes 2189.5 Chapter Review 2189.6 Further Reading 21910 Authorisation of Medical Devices 22110.1 Chapter Introduction 22110.2 Evaluation of Medical Devices in Europe 22110.2.1 Clinical Evaluation 22110.2.2 Clinical Investigations 22210.2.3 Performance Evaluation of IVDs 22510.2.4 Performance Studies of IVDs 22510.3 Evaluation of Medical Devices in the US 22610.3.1 Exempted Investigations 22710.3.2 Abbreviated Requirement Investigations 22710.3.3 IDE Investigations 22710.3.4 Labelling of Devices for Investigational Use 22910.4 Placing of Devices on the Market in the EU 23010.4.1 Designation of Notified Bodies 23010.4.2 Conformity Assessment Procedures 23210.4.2.1 Conformity Assessment Based on a Quality Management System and Assessment of Technical Documentation 23310.4.2.2 EU Type-Examination 23510.4.2.3 Production Quality Assurance 23510.4.2.4 EU Verification 23510.4.2.5 EU (Self) Declaration of Conformity 23610.4.3 Technical Documentation 23610.4.4 Labelling Requirements 23610.4.5 Registration of Economic Operators and Devices 23810.5 Placing of Devices on the Market in the US 23810.5.1 510(k) Pre-market Notification 23910.5.2 Traditional 510(k) 23910.5.3 Abbreviated 510(k) 23910.5.4 Special 510(k) 23910.5.5 De Novo 510(k) 24010.5.6 Notification and Review Procedures 24010.5.7 Pre-market Approval (PMA) 24010.5.8 Changes to a PMA-Approved Device 24110.5.9 Humanitarian Use Devices (HUDs) 24310.5.10 Labelling of Devices 24310.6 Chapter Review 24310.7 Further Reading 24411 Good Manufacturing Practice (GMP) 24511.1 Chapter Introduction 24511.2 Drug GMP Regulations and Guidance 24511.3 Essential GMP Requirements 24811.3.1 Quality Assurance System 24811.3.2 Personnel 24811.3.3 Premises and Equipment 24911.3.4 Documentation 25711.3.5 Production 25711.3.6 Quality Control 25811.3.7 Work Contracted Out 25911.3.8 Complaints, Product Recall and Emergency Un-blinding 25911.3.9 Self-inspection 25911.4 Validation 26011.4.1 Facilities and Equipment Validation 26111.4.2 Process Validation 26211.4.3 Computer Systems Validation 26211.4.4 Methods Validation 26511.4.5 Cleaning Validation 26611.4.6 Validation of Sterilisation Procedures 26711.4.7 Water Purification System Validation 26811.5 GMP Requirements for Devices 26811.6 Chapter Review 27311.7 Further Reading 27312 Oversight and Vigilance 27512.1 Chapter Introduction 27512.2 Registration of Manufacturers and Other Entities 27512.3 Manufacturing Authorisation of Medicinal Products in the EU 27512.3.1 Wholesale Distribution of Medicinal Products 27612.3.2 Registration of Economic Operators for Medical Devices on the EU market 27812.4 Registration of Producers of Drugs and Devices in the US 27812.5 Additional Licensing Requirements 27912.6 Inspections 27912.6.1 Inspection Techniques 28012.6.2 Audit Findings and Consequences 28612.7 Market Vigilance and Oversight of Drugs 28912.7.1 Pharmacovigilance in the EU 28912.7.2 Pharmacovigilance Risk Assessment Committee (PRAC) and the EudraVigilance System 29012.7.3 Pharmacovigilance and Marketing Authorisation Holders 29312.7.4 Pharmacovigilance Inspections and Audits 29412.7.5 Renewal of Marketing Authorisations 29512.7.6 Pharmacovigilance and Reporting in the US 29512.7.7 Periodic Reports 29612.8 Advertising and Promotion 29712.9 Market Vigilance and Oversight of Devices 29812.9.1 Market Vigilance in the EU 29812.9.2 Medical Device Vigilance in the US 29912.9.3 Medical Device Reporting 29912.9.4 Reports of Corrections and Removals 30012.9.5 Post-market Surveillance 30212.10 Chapter Review 30312.11 Further Reading 303Index 305