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
Practical Approaches to Risk Minimisation for Medicinal Products
Language: en
Pages: 0
Authors: World Health Organization
Categories: Drugs
Type: BOOK - Published: 2014 - Publisher:

DOWNLOAD EBOOK

Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in hu
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,
Textbook of Patient Safety and Clinical Risk Management
Language: en
Pages: 493
Authors: Liam Donaldson
Categories: Medical
Type: BOOK - Published: 2020-12-14 - Publisher: Springer Nature

DOWNLOAD EBOOK

Implementing safety practices in healthcare saves lives and improves the quality of care: it is therefore vital to apply good clinical practices, such as the WH
Patient Safety and Quality
Language: en
Pages: 592
Authors: Ronda Hughes
Categories: Medical
Type: BOOK - Published: 2008 - Publisher: Department of Health and Human Services

DOWNLOAD EBOOK

"Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community