Medical Product Regulatory Affairs

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 an associate professor of 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 has taught 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 manufacturing facility based in the region.

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