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

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.