Medical Product Regulatory Affairs

Viel Information zum attraktiven Preis: In diesem übersichtlich strukturierten, prägnant formulierten Buch finden Sie alle wichtigen gesetzlichen Vorschriften für den internationalen Pharma- und Medizingerätemarkt. Nach einer kurzen Einführung in den Prozess der Wirkstoffentwicklung und -zulassung werden nationale Bestimmungen, EU-Recht, USA-Recht, die Vergabe von Herstell- und Vermarktungslizenzen, CDER-/CBER-Richtlinien sowie relevante Teile von GLP, GCP und GMP behandelt.

Auteur
J.J. Tobin worked for many years and in various capacities within Olympus diagnostica GmbH, a company employing several 100 people who develop and manufacture in vitro diagnostic reagents. Dr. Tobin therefore has extensive experience of working within an FDA and European medical device regulatory framework.

Gary Walsh is a senior lecturer in industrial biochemistry at the University of Limerick, Ireland. He has direct industrial experience within the pharmaceutical industry, as well as extensive teaching and non-laboratory based research interests in the pharmaceutical biotechnology arena. He has published a number of books, book chapters and journal articles relevant to this publication. He also teaches elements of pharmaceutical science and regulatory affairs on an annual course provided by the University of Limerick to an international medical device company with a manufactoring facility based in the region.

Résumé
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.
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.
Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Contenu

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

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

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 Advers...