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Produktbild: Medical Product Regulatory Affairs
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Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices

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Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

11.10.2023

Abbildungen

50 schwarz-weiße und 10 farbige Abbildungen

Verlag

Wiley-VCH

Seitenzahl

336

Maße (L/B/H)

25,2/18,1/2,2 cm

Gewicht

806 g

Auflage

2. Auflage

Sprache

Englisch

ISBN

978-3-527-33326-4

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

11.10.2023

Abbildungen

50 schwarz-weiße und 10 farbige Abbildungen

Verlag

Wiley-VCH

Seitenzahl

336

Maße (L/B/H)

25,2/18,1/2,2 cm

Gewicht

806 g

Auflage

2. Auflage

Sprache

Englisch

ISBN

978-3-527-33326-4

Herstelleradresse

Wiley-VCH GmbH
Boschstraße 12
69469 Weinheim
DE

Email: GPSR Kontakt

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Die Leseprobe wird geladen.
  • Produktbild: Medical Product Regulatory Affairs
  • 1 The Aims and Structure of Regulations

    1.1 Introduction

    1.2 Purpose and Principles of Regulation

    1.3 The Legal Framework for Regulation

    1.4 Basic Legislation

    1.5 Scope of the Legislation

    1.6 Chapter Review

    1.7 Further Reading

    2 Regulatory Strategy

    2.1 Chapter Introduction

    2.2 Basic Regulatory Strategy

    2.3 Quality Assurance Systems

    2.4 Validation

    2.5 Regulatory Bodies

    2.6 International Harmonisation Bodies

    2.7 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

    2.8 Pharmaceutical Inspection Cooperation Scheme (PICS)

    2.9 The World Health Organization (WHO)

    2.10 Chapter Review

    2.11 Further Reading

    3 Drug Discovery Classification and Early Stage Development

    3.1 Chapter Introduction

    3.2 Drug Categorisation

    3.3 Drug Discovery

    3.4 Drug Development

    3.5 Drug Delivery

    3.6 Chapter Review

    3.7 Suggested Reading

    4 Non-Clinical Studies

    4.1 Chapter Introduction

    4.2 Non-Clinical Study Objectives and Timing

    4.3 Pharmacological Studies

    4.4 Bioavailability and Bioequivalence

    4.5 Toxicology Studies

    4.6 Chemistry, Manufacturing and Control Development

    (CMC)

    4.7 Quality by Design

    4.8 Quality of Biotech Products

    4.9 Good Laboratory Practice (GLP)

    4.10 Chapter Review

    4.11 Further Reading

    5 Clinical Trials

    5.1 Chapter Introduction

    5.2 Clinical Trials

    5.3 Clinical Trial Design

    5.4 Good Clinical Practice

    5.5 Clinical Trials in the EU

    5.6 Clinical Trials in The US

    5.7 Chapter Review

    5.8 Further Reading

    6 Marketing Authorisation

    6.1 Chapter Introduction

    6.2 The Application Dossier

    6.3 CTD

    6.4 Submission and Review Process in the EU

    6.5 Submission and Review Process in the US

    6.6 Chapter Review

    6.7 Further Reading

    7 Authorisation of Veterinary Medicines

    7.1 Chapter Introduction

    7.2 Overview of Development Process for Veterinary

    Medicines

    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

    7.7 Approval of Veterinary Medicines in the US

    7.8 Chapter Review

    7.9 Further Reading

    8 Variations to the Drug Authorisation Process

    8.1 Chapter Introduction

    8.2 Provisions in Support of Special Drug Applications

    8.3 Accelerated Access to New Drug Therapies

    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

    8.6 Use of Non-Authorised Drugs for Animal Treatment in the EU

    8.7 Changes to an Authorised Drug

    8.8 EU System for Processing Changes

    8.9 Processing Changes in the US

    8.10 Authorisation of Generic Drugs

    8.11 Reference Drug Exclusivity

    8.12 Other Authorisation Procedures

    8.13 Chapter Review

    8.14 Further Reading

    9 Medical Devices

    9.1 Chapter Introduction

    9.2 Regulatory Strategy for Medical Devices in the EU

    9.3 Regulatory Strategy for Medical Devices in the US

    9.4 Development of Devices

    9.5 Chapter Review

    9.6 Further Reading

    10 Authorisation of Medical Devices

    10.1 Chapter Introduction

    10.2 Evaluation of Medical Devices in Europe

    10.3 Evaluation of Medical Devices in the US

    10.4 Placing of Devices on the Market in the EU

    10.5 Placing of Devices on the Market in the US

    10.6 Chapter Review

    10.7 Further Reading

    11 Good Manufacturing Practice (GMP)

    11.1 Chapter Introduction

    11.2 Drug GMP Regulations and Guidance

    11.3 Essential GMP Requirements

    11.4 Validation

    11.5 GMP Requirements for Devices

    11.6 Chapter Review

    11.7 Further Reading