The European Medicines Agency and Future Marketing Authorisation Procedures PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download The European Medicines Agency and Future Marketing Authorisation Procedures PDF full book. Access full book title The European Medicines Agency and Future Marketing Authorisation Procedures by Great Britain. Parliament. House of Lords. Select Committee on the European Communities. Download full books in PDF and EPUB format.
Author: Great Britain. Parliament. House of Lords. Select Committee on the European Communities
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 123
Get Book Here
Book Description
Author: Great Britain. Parliament. House of Lords. Select Committee on the European Communities
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 123
Get Book Here
Book Description
Author: Great Britain. Parliament. House of Lords. Select Committee on the European Communities
Publisher:
ISBN:
Category :
Languages : en
Pages :
Get Book Here
Book Description
Author: Great Britain. Parliament. House of Lords. Select Committee on the European Communities
Publisher:
ISBN: 9780104012925
Category : Drugs
Languages : en
Pages : 100
Get Book Here
Book Description
Author: Scott L. Greer
Publisher: World Health Organization
ISBN: 9289050438
Category : Law
Languages : en
Pages : 191
Get Book Here
Book Description
Civil Society Organizations (CSOs) can make a vital contribution to public health and health systems but harnessing their potential is complex in a Europe where government-CSO relations vary so profoundly. This study is intended to outline some of the challenges and assist policy-makers in furthering their understanding of the part CSOs can play in tandem and alongside government. To this end it analyses existing evidence and draws on a set of seven thematic chapters and six mini case studies. They examine experiences from Austria Bosnia-Herzegovina Belgium Cyprus Finland Germany Malta the Netherlands Poland the Russian Federation Slovenia Turkey and the European Union and make use of a single assessment framework to understand the diverse contexts in which CSOs operate. The evidence shows that CSOs are ubiquitous varied and beneficial and the topics covered in this study reflect such diversity of aims and means: anti-tobacco advocacy food banks refugee health HIV/AIDS prevention and cure and social partnership. CSOs make a substantial contribution to public health and health systems with regards to policy development service delivery and governance. This includes evidence provision advocacy mobilization consensus building provision of medical services and of services related to the social determinants of health standard setting self-regulation and fostering social partnership. However in order to engage successfully with CSOs governments do need to make use of adequate tools and create contexts conducive to collaboration. To guide policy-makers working with CSOs through such complications and help avoid some potential pitfalls the book outlines a practical framework for such collaboration. This suggests identifying key CSOs in a given area; clarifying why there should be engagement with civil society; being realistic as to what CSOs can or will achieve; and an understanding of how CSOs can be helped to deliver.
Author: Ewout Johan Marius van Ginneken
Publisher: Univerlagtuberlin
ISBN: 379832235X
Category :
Languages : en
Pages : 210
Get Book Here
Book Description
Author: Sally Shorthose
Publisher: Kluwer Law International B.V.
ISBN: 9403530235
Category : Law
Languages : en
Pages : 840
Get Book Here
Book Description
In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Author: Manish Mudaliar
Publisher: LAP Lambert Academic Publishing
ISBN: 9783659515668
Category :
Languages : en
Pages : 80
Get Book Here
Book Description
Biological medicinal products cover a diverse field. In the European Union, many of these are under the responsibility of the European Medicines Agency and are authorised via the centralised marketing authorisation procedure, such as products manufactured by biotechnology, or advanced therapy medicinal products. Naturally derived biological maybe nationally authorised in individual Member States, rather than through the pan European procedure. Due to the diverse nature of biological products, a number of specialised groups have been established within the Agency to supervise and coordinate activities related to these products. The regulation of follow-on biologics is a rising concern for the biotech industry since many biologics are approaching the end of their patent life, and as a result, will open the market for more affordable generics."
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 30
Get Book Here
Book Description
Author: Commission of the European Communities
Publisher:
ISBN: 9789282820605
Category : Drugs
Languages : en
Pages : 196
Get Book Here
Book Description
Recoge: 1.Marketing authorisations - 2.Mutual recognition - 3.Community referral - 4.Centralised procedure - 5.Variations - 6.Community marketing authorisation - 7.General information.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212456
Category : Medical
Languages : en
Pages : 318
Get Book Here
Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
