Medical Product Regulatory Affairs : Pharmaceuticals, Diagnostics, Medical Devices /: Pharmaceuticals, Diagnostics, Medical Devices. (2023)

• Record Type: Book
• Further Information: Note: John J. Tobin, Gary Walsh.
• Authors: Tobin, John J; Walsh, Gary
• Contents: Contents; Preface XIII; 1 The Aims and Structure of Regulations 1; 1.1 Introduction 1; 1.2 Purpose and Principles of Regulation 1; 1.3 The Legal Framework for Regulation 3; 1.3.1 National Legislative Process 3; 1.3.2 EU Legislative Process 4; 1.3.3 Working with Legal Texts 5; 1.3.4 Guidance Documents 6; 1.3.5 Pharmacopoeia 7; 1.4 Basic Legislation 7; 1.4.1 EU Legislation 7; 1.4.2 US Legislation 11; 1.5 Scope of the Legislation 16; 1.6 Chapter Review 19; 1.7 Further Reading 19; 2 Regulatory Strategy 21; 2.1 Chapter Introduction 21; 2.2 Basic Regulatory Strategy 21; 2.2.1 Product Development 21; 2.2.2 Product Manufacture 21; 2.2.3 Market Vigilance 22; 2.3 Quality Assurance Systems 22; 2.3.1 Personnel 23; 2.3.2 Documentation 24; 2.3.3 Facilities and Equipment 25; Medical Product Regulatory Affairs. John J. Tobin and Gary Walsh; Copyright 2008 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim; ISBN: 978-3-527-31877-3; V; 2.3.4 Corrective and Preventive Action 25; 2.4 Validation 26; 2.5 Regulatory Bodies 27; 2.5.1 European Commission 27; 2.5.2 The EMEA 29; 2.5.3 National Competent Authorities 30; 2.5.4 Notified Bodies 32; 2.5.5 The FDA 32; 2.5.6 US Department of Agriculture 35; 2.5.7 Pharmacopoeia Authorities 36; 2.6 International Harmonisation Bodies 36; 2.7 International Conference on Harmonisation 36; 2.7.1 VICH 39; 2.7.2 The Global Harmonisation Task Force 39; 2.8 Pharmaceutical Inspection Cooperation Scheme 40; 2.9 The World Health Organization (WHO) 42; 2.10 Chapter Review 42; 2.11 Further Reading 42; 3 Drug Discovery and Development 43; 3.1 Chapter Introduction 43; 3.2 Drug Categorisation 43; 3.2.1 Prescription Status 43; 3.2.2 Physical Properties 44; 3.2.3 Mode of Action 44; 3.2.4 Therapeutic Use 45; 3.3 Drug Discovery 45; 3.4 Drug Development 50; 3.5 Drug Delivery 52; 3.5.1 Location 52; 3.5.2 Drug Characteristics 52; 3.5.3 Speed and Duration of Therapeutic Effect 53; 3.5.4 Stability 55; 3.6 Chapter Review 55; 3.7 Suggested Reading 55; 4 Non-Clinical Studies 57; 4.1 Chapter Introduction 57; 4.2 Non-Clinical Study Objectives and Timing 57; 4.3 Pharmacological Studies 58; 4.3.1 Pharmacodynamic Studies 59; 4.3.2 Pharmacokinetic/Toxicokinetic Studies 62; 4.4 Bioavailability and Bioequivalence 64; 4.5 Toxicology Studies 65; VI Contents; 4.5.1 Toxicity Studies 65; 4.5.2 Genotoxicity Studies 66; 4.5.3 Carcinogenicity Studies 67; 4.5.4 Reproductive Toxicology Studies 67; 4.6 Chemistry, Manufacturing and Control Development; (CMC) 67; 4.7 Quality of Biotech Products 68; 4.7.1 Stability Studies 68; 4.8 Good Laboratory Practice (GLP) 69; 4.9 Chapter Review 69; 4.10 Further Reading 71; 5 Clinical Trials 73; 5.1 Chapter Introduction 73; 5.2 Clinical Trials 73; 5.2.1 Phase I Trials 74; 5.2.2 Phase II Trials 74; 5.2.3 Phase III Trials 75; 5.3 Clinical Trial Design 76; 5.4 Good Clinical Practice 78; 5.5 Clinical Trials in the EU 78; 5.5.1 The Sponsor 80; 5.5.2 The Investigator.s Brochure 80; 5.5.3 The Investigator 81; 5.5.4 The Trial Protocol 81; 5.5.5 The Investigational Medicinal Product Dossier 82; 5.5.6 Informed Consent 82; 5.5.7 Manufacture of Investigational Medicinal Product 82; 5.5.8 Competent Authority Clinical Trial Application 84; 5.5.9 Independent Ethics Committee CTA 85; 5.5.10 Amendments to Clinical Trials 87; 5.5.11 Case Report Forms 87; 5.5.12 Adverse Event Reporting 87; 5.5.13 Annual Safety Report 88; 5.5.14 Monitoring of Trials 88; 5.5.15 End of Trial 88; 5.5.16 Trial Master File 88; 5.6 Clinical Trials in The US 89; 5.6.1 Investigational New Drug Application (IND) 89; 5.6.2 Institutional Review Board 91; 5.6.3 Communication with the FDA 94; 5.6.4 Labelling of Investigational Drugs 95; 5.7 Chapter Review 95; 5.8 Further Reading 95; Contents VII; 6 Marketing Authorisation 97; 6.1 Chapter Introduction 97; 6.2 The Application Dossier 97; 6.3 CTD 98; 6.3.1 Module Structure 101; 6.3.2 Module 3: Quality 101; 6.3.3 Drug Master Files 104; 6.3.4 Module 4: Non-Clinical Study Reports 105; 6.3.5 Module 5: Clinical Study Reports 105; 6.3.6 Module 2: Summaries 107; 6.3.7 Module I: Region-Specific 110; 6.3.8 Module 1: EU 110; 6.3.9 Module 1: US 113; 6.4 Submission and Review Process in the EU 114; 6.4.1 Community Authorisation 114; 6.4.2 Scientific Evaluation Process 119; 6.4.3 Decision-Making Process 120; 6.4.4 National Authorisations 121; 6.4.5 Decentralised Procedure 121; 6.4.6 Mutual Recognition Procedure 123; 6.4.7 Plasma Master Files and Vaccine Antigen Master Files 124; 6.5 Submission and Review Process in the US 124; 6.6 Chapter Review 127; 6.7 Further Reading 127; 7 Authorisation of Veterinary Medicines 129; 7.1 Chapter Introduction 129; 7.2 Overview of Development Process for Veterinary; Medicines 129; 7.2.1 Pre-Clinical Studies 130; 7.2.2 Clinical Trials 131; 7.2.3 Good Clinical Practices 131; 7.3 Authorisation of Clinical Trials in the EU 134; 7.4 Authorisation of Clinical Trials in the US 135; 7.5 Maximum Residue Limits 136; 7.6 Authorisation of Veterinary Medicines in the EU 138; 7.6.1 Applications to Establish MRLs 138; 7.6.2 Review of Applications and Establishment of MRLs 138; 7.6.3 Marketing Authorisations 142; 7.6.4 Presentation of the Dossier 143; 7.7 Approval of Veterinary Medicines in the US 144; 7.7.1 New Animal Drug Application 144; 7.7.2 Approval of Veterinary Biological Products 147; 7.8 Chapter Review 148; 7.9 Further Reading 148; VIII Contents; 8 Variations to the Drug Authorisation Process 149; 8.1 Chapter Introduction 149; 8.2 Provisions in Support of Special Drug Applications 149; 8.2.1 Orphan Drugs 149; 8.3 Accelerated Access to New Drug Therapies 151; 8.3.1 EMEA Accelerated Review 151; 8.3.2 Compassionate Use 151; 8.3.3 Fast-Track Products 152; 8.3.4 Treatment INDs 152; 8.3.5 Paediatric Applications 152; 8.4 Approval of New Drugs when Human Efficacy Studies are; not Ethical or Feasible 153; 8.5 Animal Drugs for Minor Use and Minor Species 153; 8.5.1 Conditional Approval 153; 8.5.2 Indexing 154; 8.5.3 Designation 154; 8.6 Use of Non-Authorised Drugs for Animal Treatment in the EU 154; 8.7 Changes to an Authorised Drug 154; 8.8 EU System for Processing Changes 154; 8.8.1 Extension Applications 155; 8.8.2 Major Variation (Type II) 155; 8.8.3 Minor Variation (Type IA or IB) 156; 8.9 Processing Changes in the US 156; 8.9.1 Manufacturing Change Supplements 156; 8.9.2 Major Changes 157; 8.9.3 Moderate Changes 157; 8.9.4 Minor Changes 157; 8.10 Authorisation of Generic Drugs 158; 8.10.1 EU Regulations 158; 8.10.2 US Regulations 159; 8.11 Reference Drug Exclusivity 159; 8.12 Other Authorisation Procedures 161; 8.12.1 Well-Established Medical Use Products 161; 8.12.2 Combination Products 161; 8.12.3 Homeopathic Medicines 161; 8.12.4 Traditional Herbal Medicines 162; 8.12.5 US Regulation of OTC Drugs 162; 8.13 Chapter Review 164; 8.14 Further Reading 164; 9 Medical Devices 167; 9.1 Chapter Introduction 167; 9.2 Regulatory Strategy for Medical Devices in the EU 167; 9.2.1 Use of Standards to Establish Conformity 168; 9.2.2 Classification of Devices 170; Contents IX; 9.3 Regulatory Strategy for Medical Devices in the US 173; 9.3.1 Classification of Devices 173; 9.3.1.1 Class I Devices 176; 9.3.1.2 Class II Devices 177; 9.3.1.3 Class III Devices 178; 9.3.2 Classification of New Devices 178; 9.4 Development of Devices 178; 9.4.1 Design Controls 180; 9.4.2 Design and Development Planning 180; 9.4.3 Design Input 182; 9.4.4 Design Output 182; 9.4.5 Design Verification and Design Validation 183; 9.4.6 Design Review 183; 9.4.7 Risk Analysis 184; 9.4.8 Design Changes 185; 9.5 Chapter Review 185; 9.6 Further Reading 185; 10 Authorisation of Medical Devices 187; 10.1 Chapter Introduction 187; 10.2 Evaluation of Medical Devices in Europe 187; 10.2.1 Clinical Investigations 188; 10.2.2 Performance Evaluations 190; 10.3 Evaluation of Medical Devices in the US 191; 10.3.1 IDE-Exempted Investigations 191; 10.3.2 Abbreviated Requirement Investigations 192; 10.
• Edition: 2nd
• Publisher Details: Wiley-Blackwell
• Publication Date: 2023
• Extent: 1 online resource (336 pages)
• Languages: English
• ISBNs: 9783527688982
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.