The impact of regulation on drug development provides the reader with a basic understanding of the evolution of global regulatory standards relevant to the research and development process of medicinal products and the role regulatory science plays, i.e. the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of regulated products. This book provides practical guidance on how to obtain such advice efficiently and how it is incorporated in global regulatory planning and strategies.
Reihe
Sprache
Verlagsort
Verlagsgruppe
Elsevier Science & Technology
Zielgruppe
Maße
Höhe: 234 mm
Breite: 156 mm
ISBN-13
978-1-907568-70-1 (9781907568701)
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Schweitzer Klassifikation
Dr Guenter Hennings is the Director of hgh regulatory sciences, a German consulting firm providing regulatory assistance for the development of medicinal products. He has over 30 years senior management experience in drug research and development in top-tier global pharmaceutical companies - including the successful global marketing authorisation applications for more than ten new active substances, resolution of drug safety and pharmacovigilance issues and EU referral procedures. In addition to his activities as consultant Dr Hennings currently serves as a visiting scientist at the department of Regulatory Affairs, University of Bonn, Germany. He is widely published, with a number of articles in both biochemical pharmacology and regulatory sciences.
Developing effective medicines - a contribution to public health; Evolution and maintenance of global regulatory standards; Current regulatory issues of research and development pipelines; The value chain from discovery to post-authorisation research; Health authorities provide scientific (and regulatory) advice; Strategic regulatory plans and planning.
