Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful.

More and more is being expected of volunteers and the voluntary sector in the UK. But what does it mean to be a volunteer today? This book seeks to add new insights into individual action in that part of the economy that is beyond the state and the market. Volunteering is examined from the perspective of the individual, the organisation, and the community (of place, identity or interest).

EPDF and EPUB available Open Access under CC-BY licence. This book examines the idea and practice of co-creation in public services. Informed by practical action, lived experience and research from 10 countries across Europe, including the UK, it shines new light on the theory and reality of co-creation by conceptualising it in terms of human rights, social justice and social innovation. Focusing on human dimensions, the book presents real life examples in public services as diverse as social care, health, work activation, housing and criminal justice. It also highlights the ways digital technologies can accelerate or hinder co-creation. The book confronts a paradox at the heart of co-creation: standardisation and inflexibility in planning and resourcing, or ‘concrete-ness’, counters the ‘elasticity’ required to sustain co-creation in complex contexts.

Introduction and conclusion available Open Access under CC-BY-NC licence. The turn towards a Social Investment approach to welfare implies deploying resources to enhance human capital and mobilise the productive potential of citizens, starting in early childhood. This edited collection brings regional and local realities to the forefront of social investment debates by showcasing successes, challenges and setbacks of Social Investment policies and services from ten European countries: Italy, UK, Sweden, Finland, Greece, Germany, Poland, the Netherlands, Hungary, and Spain. It provides practical, accessible illustrations of good practice, routes to success, and lessons learned. The book is informed throughout by engagement with service users and local communities, and features many previously unheard voices including front-line workers, local decision makers, volunteers and beneficiaries.

The turn towards a Social Investment approach to welfare implies deploying resources to enhance human capital and mobilise the productive potential of citizens, starting in early childhood. This edited collection brings regional and local realities to the forefront of social investment debates by showcasing successes, challenges and setbacks of Social Investment policies and services from ten European countries: Italy, UK, Sweden, Finland, Greece, Germany, Poland, the Netherlands, Hungary, and Spain. It provides practical, accessible illustrations of good practice, routes to success, and lessons learned. The book is informed throughout by engagement with service users and local communities, and features many previously unheard voices including front-line workers, local decision makers, volunteers and beneficiaries.