Therapeutic Risk Management of Medicines

Therapeutic Risk Management of Medicines
Author :
Publisher : Elsevier
Total Pages : 435
Release :
ISBN-10 : 9781908818270
ISBN-13 : 1908818271
Rating : 4/5 (70 Downloads)

Book Synopsis Therapeutic Risk Management of Medicines by : Stephen J. Mayall

Download or read book Therapeutic Risk Management of Medicines written by Stephen J. Mayall and published by Elsevier. This book was released on 2014-04-16 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders.A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US.This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. - An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines - A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) - A comprehensive guide for performing risk management more effectively throughout a product's life-cycle


Therapeutic Risk Management of Medicines Related Books

Therapeutic Risk Management of Medicines
Language: en
Pages: 435
Authors: Stephen J. Mayall
Categories: Medical
Type: BOOK - Published: 2014-04-16 - Publisher: Elsevier

DOWNLOAD EBOOK

Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines
Pharmacoepidemiology and Therapeutic Risk Management
Language: en
Pages: 0
Authors: Abraham G. Hartzema
Categories: Drug monitoring
Type: BOOK - Published: 2008 - Publisher:

DOWNLOAD EBOOK

Pharmacoepidemiology
Language: en
Pages: 977
Authors: Brian L. Strom
Categories: Medical
Type: BOOK - Published: 2012-03-05 - Publisher: John Wiley & Sons

DOWNLOAD EBOOK

Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world re
Pharmacoepidemiology
Language: en
Pages: 1220
Authors: Brian L. Strom
Categories: Medical
Type: BOOK - Published: 2019-12-16 - Publisher: John Wiley & Sons

DOWNLOAD EBOOK

This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in
Principles and Practice of Clinical Trials
Language: en
Pages: 2573
Authors: Steven Piantadosi
Categories: Medical
Type: BOOK - Published: 2022-07-19 - Publisher: Springer Nature

DOWNLOAD EBOOK

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design,