How Long to Read Medical Product Regulatory Affairs

How Long Does it Take to Read Medical Product Regulatory Affairs?

It takes the average reader 5 hours and 42 minutes to read Medical Product Regulatory Affairs by John J. Tobin

Assuming a reading speed of 250 words per minute. Learn more

Description

Medical Product Regulatory Affairs 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.

How long is Medical Product Regulatory Affairs?

Medical Product Regulatory Affairs by John J. Tobin is 341 pages long, and a total of 85,591 words.

This makes it 115% the length of the average book. It also has 105% more words than the average book.

How Long Does it Take to Read Medical Product Regulatory Affairs Aloud?

The average oral reading speed is 183 words per minute. This means it takes 7 hours and 47 minutes to read Medical Product Regulatory Affairs aloud.

What Reading Level is Medical Product Regulatory Affairs?

Medical Product Regulatory Affairs is suitable for students ages 12 and up.

Note that there may be other factors that effect this rating besides length that are not factored in on this page. This may include things like complex language or sensitive topics not suitable for students of certain ages.

When deciding what to show young students always use your best judgement and consult a professional.

Where Can I Buy Medical Product Regulatory Affairs?

Medical Product Regulatory Affairs by John J. Tobin is sold by several retailers and bookshops. However, Read Time works with Amazon to provide an easier way to purchase books.

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