Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

ISBN-13: 9783527333264 / Angielski / Twarda / 2024 / 350 str.

John J. Tobin;Gary Walsh

Spis treści

1 The Aims and Structure of Regulations1.1 Introduction1.2 Purpose and Principles of Regulation1.3 The Legal Framework for Regulation1.4 Basic Legislation1.5 Scope of the Legislation1.6 Chapter Review1.7 Further Reading2 Regulatory Strategy2.1 Chapter Introduction2.2 Basic Regulatory Strategy2.3 Quality Assurance Systems2.4 Validation2.5 Regulatory Bodies2.6 International Harmonisation Bodies2.7 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use2.8 Pharmaceutical Inspection Cooperation Scheme (PICS)2.9 The World Health Organization (WHO)2.10 Chapter Review2.11 Further Reading3 Drug Discovery Classification and Early Stage Development3.1 Chapter Introduction3.2 Drug Categorisation3.3 Drug Discovery3.4 Drug Development3.5 Drug Delivery3.6 Chapter Review3.7 Suggested Reading4 Non-Clinical Studies4.1 Chapter Introduction4.2 Non-Clinical Study Objectives and Timing4.3 Pharmacological Studies4.4 Bioavailability and Bioequivalence4.5 Toxicology Studies4.6 Chemistry, Manufacturing and Control Development(CMC)4.7 Quality by Design4.8 Quality of Biotech Products4.9 Good Laboratory Practice (GLP)4.10 Chapter Review4.11 Further Reading5 Clinical Trials5.1 Chapter Introduction5.2 Clinical Trials5.3 Clinical Trial Design5.4 Good Clinical Practice5.5 Clinical Trials in the EU5.6 Clinical Trials in The US5.7 Chapter Review5.8 Further Reading6 Marketing Authorisation6.1 Chapter Introduction6.2 The Application Dossier6.3 CTD6.4 Submission and Review Process in the EU6.5 Submission and Review Process in the US6.6 Chapter Review6.7 Further Reading7 Authorisation of Veterinary Medicines7.1 Chapter Introduction7.2 Overview of Development Process for VeterinaryMedicines7.3 Authorisation of Clinical Trials in the EU7.4 Authorisation of Clinical Trials in the US7.5 Maximum Residue Limits (MRLs)7.6 Authorisation of Veterinary Medicines in the EU7.7 Approval of Veterinary Medicines in the US7.8 Chapter Review7.9 Further Reading8 Variations to the Drug Authorisation Process8.1 Chapter Introduction8.2 Provisions in Support of Special Drug Applications8.3 Accelerated Access to New Drug Therapies8.4 Approval of New Drugs when Human Efficacy Studies arenot Ethical or Feasible8.5 Animal Drugs for Minor Use and Minor Species8.6 Use of Non-Authorised Drugs for Animal Treatment in the EU8.7 Changes to an Authorised Drug8.8 EU System for Processing Changes8.9 Processing Changes in the US8.10 Authorisation of Generic Drugs8.11 Reference Drug Exclusivity8.12 Other Authorisation Procedures8.13 Chapter Review8.14 Further Reading9 Medical Devices9.1 Chapter Introduction9.2 Regulatory Strategy for Medical Devices in the EU9.3 Regulatory Strategy for Medical Devices in the US9.4 Development of Devices9.5 Chapter Review9.6 Further Reading10 Authorisation of Medical Devices10.1 Chapter Introduction10.2 Evaluation of Medical Devices in Europe10.3 Evaluation of Medical Devices in the US10.4 Placing of Devices on the Market in the EU10.5 Placing of Devices on the Market in the US10.6 Chapter Review10.7 Further Reading11 Good Manufacturing Practice (GMP)11.1 Chapter Introduction11.2 Drug GMP Regulations and Guidance11.3 Essential GMP Requirements11.4 Validation11.5 GMP Requirements for Devices11.6 Chapter Review11.7 Further Reading

O autorze

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 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.