Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices - Image 1

£69.48

Wiley Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Name: Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
Brand: Wiley
Price: 69.48 GBP
Availability: InStock

Law

It has never been this cheap. We have no record of a lower price.

£69 today · cheaper than every other day in the last 3 months

NEW HERE?

Amazon shows you one price. We show you all of them.

Tosheroon watches Amazon prices so you don't have to. Every product on Amazon has a price history — we make it visible. Set the price you'd actually pay, and we'll email you the second it gets there. No app, no account, one email.

WHAT'S ON THIS PAGE

↓ Price chart
when this has been cheap or pricey

↓ Forecast
where the price is heading next

↓ Statistics
all-time high & low, recent range

↑ Price alert
name your number, we'll email you

Price History & Forecast

Grey patches = out of stock. Cheaper = lower on the chart. Hover for exact prices.

Last 52 days · 52 data points (no recent data)

Historical

Generating forecast…

Price Distribution

Price distribution over 52 days • 2 price levels

Days at Price

Current Price

Price Analysis

Most common price: £69 (29 days, 55.8%)

Price range: £69 - £75

Price levels: 2 different prices over 52 days

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.

Key Features

New Store Stock

Product Specifications

Brand: Wiley
Format: hardcover
ASIN: 3527333266
Category: Books > Subjects > Business, Finance & Law > Law
Domain: Amazon UK
Release Date: 11 October 2023
Listed Since: 04 February 2012

Barcode

No barcode data available

Wiley Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

It has never been this cheap. We have no record of a lower price.

Price History & Forecast

Price Distribution

Price Analysis

Description

Key Features

Product Specifications

Barcode

Similar Products You Might Like

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

FDA Regulatory Affairs: Third Edition

Regulatory Affairs in the Pharmaceutical Industry

FDA Regulatory Affairs: Third Edition

Guide to EU Pharmaceutical Regulatory Law

Das europäische Arzneimittelrecht: Zentrale Rechtsfragen des Arzneimittelzulassungsverfahrens

Guide to EU and UK Pharmaceutical Regulatory Law

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

Computer System Validation: Pharmaceutical, Biologics, and Medical Device Regulations, Concise Reference

Regulatory Protection in the Pharmaceutical and Life Science Industries: Challenges, Opportunities and Ongoing Reform (Elgar Monographs in Intellectual Property Law)

Specification of Drug Substances and Products: Development and Validation of Analytical Methods

The Law and Regulation of Medicines and Medical Devices

Benefit-Risk Assessment in Pharmaceutical Research and Development (Chapman & Hall/CRC Biostatistics Series)

International Drug Regulatory Mechanisms

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Career Options in the Pharmaceutical and Biomedical Industry: An Insider’s Guide

Practical Guide to 21 CFR Part 11: Your Essential Handbook for Navigating 21 CFR Part 11

Medical Product Safety Evaluation: Biological Models and Statistical Methods (Chapman & Hall/CRC Biostatistics Series)

International Pharmaceutical Product Registration: 200 (Drugs and the Pharmaceutical Sciences)

Biosimilars and Interchangeable Biologics: Strategic Elements

Mastering Strategic Marketing For Specialty Pharmaceuticals: A Hands-on Guide