Author: United States. Food and Drug Administration. Task Force on Risk ManagementPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 24
Book Description
Managing the Risks from Medical Product Use
Author: United States. Food and Drug Administration. Task Force on Risk ManagementPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 24
Book Description
Managing the Risks from Medical Product Use
Author: Managing the Risks from Medical Product Use
Author: United States. Food and Drug Administration. Task Force on Risk ManagementPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 15
Book Description
Managing the Risks from Medical Product Use
Author: Managing Risks from Medical Product Use
Author: United States Government Printing OfficePublisher:
ISBN: 9780160503078
Category :
Languages : en
Pages : 168
Book Description
Managing the Risks from Medical Product Use
Author: Therapeutic Risk Management of Medicines
Author: Stephen J. MayallPublisher: Elsevier
ISBN: 1908818271
Category : Medical
Languages : en
Pages : 435
Book Description
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
Managing the Risks from Medical Product Use
Author: United States. Food and Drug Administration. Task Force on Risk ManagementPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 172
Book Description
Mastering Safety Risk Management for Medical and In Vitro Devices
Author: Jayet MoonPublisher: Quality Press
ISBN: 1636941729
Category : Business & Economics
Languages : en
Pages : 195
Book Description
When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).
Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQPublisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.