This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

The authors aim to provide readers with a comprehensive account of the global pharmaceutical systems and have written specifically with the needs of pharmacy students taking master's degrees in mind. The text is particularly suited to Pharmaceutical Care/Social Pharmacy programs.

The first three chapters are intended to familiarize the reader with social science methods and models. The succeeding chapters describe different parts of the drug system. In general each of these chapters starts with an international overview and is followed by an analysis of the aims and functions of the component from the perspective of a nation.

Until this book these subjects have not been brought together and as such this presents a unique understanding of global social pharmacy. This book is timely given that pharmacists are encouraged to broaden their day-to-day practice, so that they become more involved with advising clients, managing medicines and supporting the promotion of health. In the light of developments in the 'extended role' of pharmacists, students of pharmacy are required to understand the social context of health, illness and professional practice.

This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients' access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

Offers a social view of the activities leading to the timely patient access to medicines including: drug research, drug production, drug distribution, drug prescribing, drug information and drug control Provides theoretical models to enable pharmacists to understand the organization of drug systems in their particular global territory Written specifically with the needs of pharmacy students taking Master's degrees in mind

There is growing interest in the impact of patients' illness on the quality of life of family members. Much of the previous research focuses on the impact on family members who are also carers, or is restricted to one disease or disease area. This book describes the conceptualisation, development and validation of the first generic quality of life measure for family members, the Family Reported Outcome Measure (FROM-16). The book presents the findings of a literature review looking at current research into the area of family quality of life and highlights the need for a generic family measure. The process and results of interviews with 126 family members are discussed, and the development and validation processes of the measure are described in detail, including Item Response Theory and Classical Test Theory. Finally, this book details the potential uses of the FROM-16 and the challenges faced by clinicians, researchers and society in measuring family quality of life.