The book Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices is written by John J. Tobin, and Gary Walsh. Medicines and medical devices are among the most tightly regulated products in the developed world. This chapter introduces you to the basic principles and concepts behind regulations so you can fully appreciate the importance of compliance. The chapter then analyzes the general legislative framework used to create regulations and identifies the core legal texts used to regulate such products in the European Union (EU) and the United States of America (USA). Finally, the chapter examines the legal definitions of drugs and medical devices, which are central to determining the scope of regulations.
In a modern constitutional democracy, laws are created through a hierarchical legislative process. You will find the main legal principles laid out in a constitution, which derives its legitimacy directly from the will of the people and can only be amended by referendum. The constitution establishes your basic rights as an individual in the state and establishes a system of government that includes the legislative, executive, and judicial branches of government.
Topics of this Edition
1 The Aims and Structure of Regulations
2 Regulatory Strategy
3 Drug Discovery and Development
4 Non-Clinical Studies
5 Clinical Trials
6 Marketing Authorisation
7 Authorisation of Veterinary Medicines
8 Variations to the Drug Authorisation Process
9 Medical Devices
10 Authorisation of Medical Devices
11 Good Manufacturing Practice (GMP)
12 Oversight and Vigilance
Overview of Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
Written in a clear and concise style by an experienced author, this attractively priced book covers regulatory issues in the world’s leading pharmaceutical and medical device markets, making it the most comprehensive in its field. After a look at drug development, entire sections are devoted to EU and national regulatory issues, application and retention of manufacturing licenses, and regulation in the US. Other topics covered include CDER, CBER, and marketing and manufacturing licenses. , the ICH process, and good laboratory/clinical/manufacturing practices. Everything pharmacologists, bioengineers, pharmaceutical engineers, pharmacy students, and those working in the pharmaceutical industry need to know about medical regulatory issues.
|Book Name||Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices|
|Author of Book||John J. Tobin, Gary Walsh|