Medical Product Regulatory Affairs

Durch die Behandlung einer Vielzahl unterschiedlicher Produkttypen und der wichtigsten globalen Märkte ist dieses Lehrwerk genau richtig für Kurse rund um Zulassungsfragen medizinischer Geräte. Eignet sich auch hervorragend als Einführung in das Thema.

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 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.

Texte du rabat

Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. 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. Medical Product Regulatory Affairs includes information on:

• Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia
• Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation
• Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery
• Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence
• Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

Contenu
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