International Pharmaceutical Product Registration, Second Edition

With 45 chapters that cover all of the major technical and clinical topics in a Common Technical Document registration, including summaries, quality of the drug substance and dosage form, nonclinical studies and clinical trials, this Second Edition provides a roadmap for International Conference on Harmonisation (ICH) and other technical and regulatory requirements for global filings in the US, EU, Japan and elsewhere.

Anthony C. Cartwright is a Pharmaceutical Regulatory Consultant, Harpenden, UK. Tony Cartwright is involved in numerous professional organizations including the Royal Pharmaceutical Society of Great Britain, the Drug Information Association and The Organisation for Professionals in Regulatory Affairs, where he chairs their Lifelong Learning Committee. He was formerly Chair of the European CPMP Quality Working Party. He was an active participant in working groups and conferences of the International Conference on Harmonisation, particularly involved in guidelines on stability testing and impurities. He has authored over 30 scientific and technical publications and book chapters. He is the Co-editor of Informa Healthcare's Pharmaceutical Product Licensing: Requirements for Europe and the first edition of International Pharmaceutical Product Registration. Brian R. Matthews, Ph D, is Senior Director, EU Registration and Authorised Representative for Alcon Laboratories and is based in the UK. He is involved with a number of professionals associations such as the Parenteral Drug Association, The Organisation for Professional in Regulatory Affairs and the Royal Pharmaceutical Society of Great Britain. He is also involved in a number of standards committee within the British Standards Institution, the European Standards Committee and the International Standards Organization where his particular interests include methods of sterilization, animal materials used in the manufacture of medical devices, contact lens care products, interaocular lenses, irrigation solutions, viscosurgical products and Braille for application to pharmaceutical labelling. He is also a member of committees within the British Pharmacopoeia relating to pharmacy and to microbiology. Brian has written a number of papers on a wide range of topics relating to pharmaceutical legislation. He is on the editorial boards for the Regulatory Affairs Journal (Pharma) and (Medical Devices) and the European Journal of Parenteral and Pharmaceutical Sciences. In addition to co-editing Pharmaceutical Product Licensing: Requirements for Europe and the first edition of International Pharmaceutical Product Registration he is also the author of Pharmaceutical Excipients: A Manufacturer's Handbook.