David Elder – författare

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.•    Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies•    Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines•    Uses case studies to help readers understand and apply ICH guidelines•    Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines•    Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.•    Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies•    Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines•    Uses case studies to help readers understand and apply ICH guidelines•    Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines•    Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.•    Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies•    Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines•    Uses case studies to help readers understand and apply ICH guidelines•    Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines•    Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Cirencester is one of the most remarkable towns in Britain. From its Roman beginnings around AD 75, when it was classed second only in importance to London, to its current status as the ‘Capital of the Cotswolds’, it has always punched well above its weight. The ‘A-side’ of its history as a small market town which developed at the centre of the Cotswold wool trade is well documented, but what about its ‘ ip-side’? Much of the town’s fascinating history has either been overlooked or lies hidden below the surface. Well-known local author David Elder delves deep into Cirencester’s lost, forgotten and hidden histories, recounting some remarkable stories. Learn, for example, about some of Cirencester’s minor celebrities and local characters, including the Victorian female astronomer who became a national expert in sunspots and solar eclipses. He also unearths fascinating facts, celebrating, for example, the town’s accolade of having the UK’s oldest public outdoor swimming pool in continuous use, and explaining why it was important for passengers travelling on the railways around the mid-nineteenth century to understand that Cirencester time was 7 ½ minutes earlier than London time.With tales of remarkable characters, unusual events and tucked-away or disappeared historical buildings and locations, Secret Cirencester will appeal to all those with an interest in the history of this town in Gloucestershire.

Stroud has been an important market town in the Cotswolds for centuries. At the heart of the five valleys, its prosperity was founded on the wool trade in the Middle Ages. During the Industrial Revolution, the town became a textile centre with numerous mills built along its streams. The canal network facilitated trade and industry in the town, as did the arrival of Brunel’s Great Western Railway. The town is renowned today for its historic buildings and steep streets and has become an independent cultural centre with a strong environmental community, which even boasted its own currency for a while in recent years. Through the centuries Stroud’s unusual history has encompassed the country’s oldest anti-slavery memorial, Huguenot and Jewish communities, a Victorian Communist colony, the last pistol duel in England, food riots, suffragettes, suffragists and much more.With tales of remarkable characters, unusual events and tucked-away or disappeared historical buildings and locations, Secret Stroud will appeal to all those with an interest in the history of this Gloucestershire town.

With its own traditions and strong sense of identity and independence, the Forest of Dean appears as a separate, almost secret, part of Gloucestershire. Some of its ancient history has only recently come to light, after lying hidden beneath the forest canopy for millennia, but its more recent past also evokes surprise and wonder. Local author David Elder takes the reader on an A–Z tour around the region’s history, uncovering the stories of its buildings, famous (and infamous) sons and daughters, natural features and fascinating old routes and thoroughfares. From its highest point, once known as Yarleton Hill, to the shores of its two vast rivers, we discover hidden places, many mentioned in the Domesday Book, characterful rocks and ancient trees. Alongside freeminers, rebel leaders, trade union rights campaigners, community doctors, composers, poets and pioneering metallurgists we find enterprising members of a family who gave their name to the household brand of a famous malted drink, and a wealthy merchant and, later, Lord Mayor of London immortalised in folklore.A–Z of the Forest of Dean reveals the history behind the area, its towns and villages, industries and the people connected with it. Alongside the famous historical connections, are unusual characters, tucked-away places and unique events that are less well-known. Fully illustrated throughout, this book will appeal to all those with an interest in this spectacular corner of England.

With its own traditions and strong sense of identity and independence, the Forest of Dean appears as a separate, almost secret, part of Gloucestershire. Some of its ancient history has only recently come to light, after lying hidden beneath the forest canopy for millennia, but its more recent past also evokes surprise and wonder. Local author David Elder takes the reader on an A-Z tour around the region's history, uncovering the stories of its buildings, famous (and infamous) sons and daughters, natural features and fascinating old routes and thoroughfares. From its highest point, once known as Yarleton Hill, to the shores of its two vast rivers, we discover hidden places, many mentioned in the Domesday Book, characterful rocks and ancient trees. Alongside freeminers, rebel leaders, trade union rights campaigners, community doctors, composers, poets and pioneering metallurgists we find enterprising members of a family who gave their name to the household brand of a famous malted drink, and a wealthy merchant and, later, Lord Mayor of London immortalised in folklore.A Z of the Forest of Dean reveals the history behind the area, its towns and villages, industries and the people connected with it. Alongside the famous historical connections, are unusual characters, tucked-away places and unique events that are less well-known. Fully illustrated throughout, this book will appeal to all those with an interest in this spectacular corner of England.

The Cotswolds area has played an important role in history through the ages and women from the Cotswolds have been at the forefront of many significant moments in the area’s history and associated with many of its special places. In this book the stories of these remarkable women are explored; some of them are well known and others deserve greater attention. Amongst them are the Gloucestershire nurse and poet of the First World War Eva Dobell and textile designer Dorothy Larcher; social worker and women’s rights campaigner Lilian Faithfull and suffragist Harriet Mcllquham; the astronomer Elizabeth Brown and educational pioneer Dorothea Beale as well as many other names and stories.Extraordinary Cotswolds Women is a celebration of some of the remarkable women in the history of the Cotswolds. Their stories include tales of tales of writers and artists, reformers and scientists, builder, farmers and royalty and much more. All those who would like to know more about the history of the Cotswolds will find this book of interest.