Key Issues In Pharmaceuticals Law

Download Key Issues In Pharmaceuticals Law full books in PDF, epub, and Kindle. Read online Key Issues In Pharmaceuticals Law ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!

Key Issues in Pharmaceuticals Law

Author : José Luis Valverde
Publisher : IOS Press
ISBN 13 : 9781586038403
Total Pages : 176 pages
Book Rating : 4.0/5 (384 download)

DOWNLOAD NOW!

Book Synopsis Key Issues in Pharmaceuticals Law by : José Luis Valverde

Download or read book Key Issues in Pharmaceuticals Law written by José Luis Valverde and published by IOS Press. This book was released on 2007 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The focus of Key Issues in Pharmaceuticals Law is on the ongoing achievement of an authentic world code for medicinal products - a so-called "Pharmacopoeia"--Through scientific technical harmonization. The legal dimension of medicinal products conditions the whole sector and it acquires a global dimension through the demand to protect people's health. Hence it is necessary to go forward to total harmonization of all its aspects. A global legal statute for medicinal products is justified by the very nature of the product, by its social control and the need for it to circulate freely, although limitations can be accepted, for reasons of solidarity with less favored populations. Awareness must arise that the challenge for healthcare is not going to find an adequate answer at the world level without a qualitative change in the world organization of the UN. The globalized world we live in demands reinforced continental solidarity, if we are to confront the common problems and bring about international order. A scientific technical code on the quality of medicinal products is essential for a statute on medicines. That code is the Pharmacopoeia."--Publisher.

Contemporary Issues in Pharmaceutical Patent Law

Author : Bryan Mercurio
Publisher :
ISBN 13 : 9781138934481
Total Pages : 0 pages
Book Rating : 4.9/5 (344 download)

DOWNLOAD NOW!

Book Synopsis Contemporary Issues in Pharmaceutical Patent Law by : Bryan Mercurio

Download or read book Contemporary Issues in Pharmaceutical Patent Law written by Bryan Mercurio and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection explores the complexities associated with the intersection of pharmaceutical law and policy and public health. Focusing on patent and relevant regulatory laws, the collection provides a comprehensive overview of the most important and pressing issues governments are currently facing in regards to ensuring access to medicines at an affordable cost. Each chapter focuses on a separate issue and offers clear, balanced and detailed analysis of the international framework, trends and available policy options.

The Law and Ethics of the Pharmaceutical Industry

Author : M.N.G. Dukes
Publisher : Elsevier
ISBN 13 : 0080459366
Total Pages : 429 pages
Book Rating : 4.0/5 (84 download)

DOWNLOAD NOW!

Book Synopsis The Law and Ethics of the Pharmaceutical Industry by : M.N.G. Dukes

Download or read book The Law and Ethics of the Pharmaceutical Industry written by M.N.G. Dukes and published by Elsevier. This book was released on 2005-11-04 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation.Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change.*Provides a balanced picture of the current role of the pharmaceutical industry in society*Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases*This is the only book addressing the legal implications of big pharma activities and ethical standards

Pharmacy Law and Practice

Author : Jon Merrills
Publisher : Academic Press
ISBN 13 : 0123946182
Total Pages : 570 pages
Book Rating : 4.1/5 (239 download)

DOWNLOAD NOW!

Book Synopsis Pharmacy Law and Practice by : Jon Merrills

Download or read book Pharmacy Law and Practice written by Jon Merrills and published by Academic Press. This book was released on 2013-04-19 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacy Law and Practice, Fifth Edition provides a straightforward and useable guide for students, practitioners, academics and others interested in pharmacy law and practice in the United Kingdom. This multi-dimensional book includes discussions of socio-political influences on legal developments to provide greater insight to the reader. It clearly sets out the background to regulatory issues together with simple and practical statements of what a pharmacist has to do to obey the law. As in previous editions, this book discusses topics thematically rather than by statute. It is a unique and reader-friendly guide that boils down the complex or difficult language of the law, describes the reasons behind it, and illustrates the application to pharmacy practice. - Thoroughly updated to reflect regulatory and legal developments in areas including employment law, online transactions and internet pharmacies, non-medical prescribing and more - Takes an intuitive, problem-solving approach and discusses topics thematically rather than by statute to show how all of the larger pieces fit together - The electronic version of this book contains valuable links to provide readers with the most current information in a rapidly changing subject area

Drug Information

Author : Patrick M. Malone
Publisher : McGraw Hill Professional
ISBN 13 : 0071492038
Total Pages : 907 pages
Book Rating : 4.0/5 (714 download)

DOWNLOAD NOW!

Book Synopsis Drug Information by : Patrick M. Malone

Download or read book Drug Information written by Patrick M. Malone and published by McGraw Hill Professional. This book was released on 2010-05-12 with total page 907 pages. Available in PDF, EPUB and Kindle. Book excerpt: Extensive coverage of the Internet as a source of and distribution means for drug information, and detailed sections on evaluating medical literature from clinical trials Audience includes Pharmacists, Pharmacy students and Pharmacy schools Updated to include using PDAs for medication information Covers the ethical and legal aspects of drug information management Nothing else like it on the market

Pharmacy Law Desk Reference

Author : Albert I Wertheimer
Publisher : Routledge
ISBN 13 : 1136406239
Total Pages : 558 pages
Book Rating : 4.1/5 (364 download)

DOWNLOAD NOW!

Book Synopsis Pharmacy Law Desk Reference by : Albert I Wertheimer

Download or read book Pharmacy Law Desk Reference written by Albert I Wertheimer and published by Routledge. This book was released on 2012-10-12 with total page 558 pages. Available in PDF, EPUB and Kindle. Book excerpt: Your primary source for information on the legal issues of pharmaceutical practice, care, and activity Today’s pharmacist is faced with legal, ethical, and moral concerns in making the transition from traditional pharmacy practice to an expanded role in clinical pharmacy and patient drug management services. Pharmacy Law Desk Reference is a primer on the legal aspects of pharmaceutical practice, providing background on foundational legal concepts, and guidance on the Food, Drug, and Cosmetic Act (FDCA), the Controlled Substances Act (CSA), and the Federal Trade Commission. This unique book examines the major topics that impact pharmaceutical care, including professional liability insurance; the need for supportive personnel in pharmacy practice; patent law, trademarks, and copyrights; law and ethics; business law; HIPAA privacy in the pharmacy; electronic prescribing; and medication error reporting. Handy tables, figures, and exhibits make complex information easy to access and understand. The better pharmacists understand the regulatory and legislative framework that shapes their practice, the better they will be able to carry out their responsibilities to patients. Pharmacy Law Desk Reference offers a broad scope on established legal subjects, the current direction of the profession, and important contemporary topics that affect the clinical role of the practicing pharmacist. Each chapter is authored by a nationally recognized authority on one or more aspect of pharmacy law and many of the contributors are active in the American Society of Pharmacy Law. Topics addressed in Pharmacy Law Desk Reference include: telepharmacy collaborative drug therapy management trade secrets and trade secret protection anti-competitive practices the threat of civil and criminal liability the Health Insurance Portability and Accountability Act of 1996 (HIPAA) FDA inspections consumer protection laws credentialing pharmacy compounding accreditation employment contracts Medicaid and Medicare controlled substance registration and prescription orders forged prescription orders and many more Pharmacy Law Desk Reference is a comprehensive resource on the professional, legal, and contemporary issues in pharmacy practice. It is a primary reference guidebook for pharmacy practitioners, leaders of state and national pharmacists associations, members of state boards of pharmacy, educators and students, and an essential addition to all pharmacy libraries.

Bringing Medical Devices to Market

Author : Charlene Cho
Publisher :
ISBN 13 : 9781641059718
Total Pages : 389 pages
Book Rating : 4.0/5 (597 download)

DOWNLOAD NOW!

Book Synopsis Bringing Medical Devices to Market by : Charlene Cho

Download or read book Bringing Medical Devices to Market written by Charlene Cho and published by . This book was released on 2021 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compliance concerns that arise in the context of bringing a medical device to market"--

Essentials of Pharmacy Law

Author : Douglas J. Pisano
Publisher : CRC Press
ISBN 13 : 9781420012767
Total Pages : 140 pages
Book Rating : 4.0/5 (127 download)

DOWNLOAD NOW!

Book Synopsis Essentials of Pharmacy Law by : Douglas J. Pisano

Download or read book Essentials of Pharmacy Law written by Douglas J. Pisano and published by CRC Press. This book was released on 2002-07-29 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the laws and regulations relating to the practice of pharmacy, and the regulation and control of drugs cosmetics, and medical devices. Most available pharmacy law texts thus far have been written by lawyers and present heavy, dense, legalistic reading that focuses on legal theory. Essentials of Pharmacy Law is written by a practicing pharmacist in clear, accessible, contemporary prose that concentrates on application. This user-friendly text is a compilation and commentary of selected federal laws and regulations pertaining to the general practice of pharmacy in the United States. It covers topics in a simple and concise format. Furthermore, case studies and review questions and a bulleted summary of key points make for easy reading and aid in comprehension. Essentials of Pharmacy Law will be extremely useful to senior pharmacy students preparing for the Multi-State Jurisprudence Exam (NABLEX MJPE). as well as the voluntary Pharmacist Competency Exam offered to practicing pharmacists. It alsoalso serves as a valuable reference for pharmacy students, practicing pharmacists seeking licensure by reciprocity and/or preparing for the MJPE, pharmacy technicians who are in need of a comprehensive update, and other interested healthcare professionals.

Competition Law and Policy in the Japanese Pharmaceutical Sector

Author : Akira Negishi
Publisher : Springer Nature
ISBN 13 : 9811678146
Total Pages : 252 pages
Book Rating : 4.8/5 (116 download)

DOWNLOAD NOW!

Book Synopsis Competition Law and Policy in the Japanese Pharmaceutical Sector by : Akira Negishi

Download or read book Competition Law and Policy in the Japanese Pharmaceutical Sector written by Akira Negishi and published by Springer Nature. This book was released on 2022-02-08 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first book published that focuses on competition law and policy in the Japanese pharmaceutical sector. It consists of chapters written and edited by academics who research the industry from various perspectives, including economics, competition law, pharmaceutical regulations, and intellectual property law. Competition policies involving pharmaceutical products attract attention from academics and policymakers worldwide. The pharmaceutical industry is regulated by drug laws that vary from country to country and are affected by differing practices and industrial structures. The book begins by examining drug regulations and trade practices in the industry that are peculiar to Japan and its healthcare system. It then presents the Japanese Antimonopoly Act and cases involving it, and discussions of current competition law issues in the Japanese pharmaceutical industry. The book also discusses innovation and intellectual property and economic analyses of pharmaceutical regulations and drug discovery. The chapters include comparative studies on Japanese regulations vs. those in the European Union and the United States. Japan is one of the biggest pharmaceutical markets in the world. With this in mind, the book provides “one-stop shopping” for anyone interested in pharmaceutical regulations in the country. Covering the basics but extending to in-depth explorations of complex problems, this book appeals not only to students and academics, pharmaceutical companies and regulators, but also to those dealing with real-world policy issues that encompass competition policy, intellectual property, and pharmaceutical regulation. Chapter 11 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com

Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law

Author : Amalia Athanasiadou
Publisher : Kluwer Law International B.V.
ISBN 13 : 9403501146
Total Pages : 520 pages
Book Rating : 4.4/5 (35 download)

DOWNLOAD NOW!

Book Synopsis Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law by : Amalia Athanasiadou

Download or read book Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law written by Amalia Athanasiadou and published by Kluwer Law International B.V.. This book was released on 2018-08-14 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.

Pharmaceutical Industry Antitrust Handbook

Author :
Publisher : American Bar Association
ISBN 13 : 9781604425628
Total Pages : 484 pages
Book Rating : 4.4/5 (256 download)

DOWNLOAD NOW!

Book Synopsis Pharmaceutical Industry Antitrust Handbook by :

Download or read book Pharmaceutical Industry Antitrust Handbook written by and published by American Bar Association. This book was released on 2009 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Chapters on Pharmaceutical Law

Author : Stefaan Callens
Publisher :
ISBN 13 : 9789050950862
Total Pages : 0 pages
Book Rating : 4.9/5 (58 download)

DOWNLOAD NOW!

Book Synopsis Chapters on Pharmaceutical Law by : Stefaan Callens

Download or read book Chapters on Pharmaceutical Law written by Stefaan Callens and published by . This book was released on 2000 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book aims to give an overview of the European legal issues on medicinal products, starting from the development of the products all through to the selling of them. Topics such as the definition of a medicinal product and the description of important issues related to research and development are dealt with. Furthermore, the book analyses the marketing authorisation of a medicinal product, including the issues related to leaflets and packaging. In addition, the book gives an overview of the rules related to the distribution and import (in parallel) of medicines as well as the protection of innovation by means of intellectual property rights. Recent developments, such as the impact of internet and e-commerce as well as the processing of health data, are also examined. The political important issues of pricing and reimbursement of medicines is covered as well. The book ends with a chapter on the selling of medicinal products at pharmacies. The book is written for lawyers as well as non lawyers (such as directors and marketing managers of pharmaceutical companies, officials of public authorities in health care, policy makers etc.) working or interested in the pharmaceutical sector. With contributions from: S. Callens, F. De Visscher, L. Hombroeckx, B. Janse, A. Mencik, T. Schoors, J. ter Heerdt and A. Vijverman.

The Generic Challenge

Author : Martin A. Voet
Publisher : Brown Walker Press (FL)
ISBN 13 : 9781627346177
Total Pages : 230 pages
Book Rating : 4.3/5 (461 download)

DOWNLOAD NOW!

Book Synopsis The Generic Challenge by : Martin A. Voet

Download or read book The Generic Challenge written by Martin A. Voet and published by Brown Walker Press (FL). This book was released on 2016-09-07 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Fifth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

The Generic Challenge

Author : Martin A. Voet
Publisher : Brown Walker Press
ISBN 13 : 9781612337289
Total Pages : 0 pages
Book Rating : 4.3/5 (372 download)

DOWNLOAD NOW!

Book Synopsis The Generic Challenge by : Martin A. Voet

Download or read book The Generic Challenge written by Martin A. Voet and published by Brown Walker Press. This book was released on 2013-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Fourth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind available on this important subject.

Drug Safety

Author : United States. General Accounting Office
Publisher :
ISBN 13 :
Total Pages : 12 pages
Book Rating : 4.:/5 (7 download)

DOWNLOAD NOW!

Book Synopsis Drug Safety by : United States. General Accounting Office

Download or read book Drug Safety written by United States. General Accounting Office and published by . This book was released on 2001 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:

EU Law of Competition and Trade in the Pharmaceutical Sector

Author : Pablo Figueroa (Lawyer)
Publisher :
ISBN 13 : 9781785362606
Total Pages : 0 pages
Book Rating : 4.3/5 (626 download)

DOWNLOAD NOW!

Book Synopsis EU Law of Competition and Trade in the Pharmaceutical Sector by : Pablo Figueroa (Lawyer)

Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa (Lawyer) and published by . This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition/antitrust law and trade regulation in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-profile competition enforcers, this work provides valuable insider knowledge on the application of competition law and policies to the pharmaceutical industry. Key features include: Extensive commentary on the legislation and the latest case law and administrative precedents in the pharmaceutical sector, at both EU and national level Coverage of various key developments including the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers In-depth analysis of topics commonly raised in the pharmaceutical sector including: pricing policies, IP life-cycle management, IP licensing and horizontal cooperation agreements Key economic and business perspectives to accompany legal analysis, providing the reader with a rounded view of the subject matter. This book will be a useful resource for lawyers and in-house counsel active in the pharmaceutical sector. The information and analysis provided will prepare readers to take on cases and drive the antitrust review of transactions and agreements within the industry. Researchers, economists and civil servants with an interest in competition law and trade regulation can also benefit from the practical insights provided therein.

The Generic Challenge

Author : Martin A Voet
Publisher :
ISBN 13 : 9781627347471
Total Pages : pages
Book Rating : 4.3/5 (474 download)

DOWNLOAD NOW!

Book Synopsis The Generic Challenge by : Martin A Voet

Download or read book The Generic Challenge written by Martin A Voet and published by . This book was released on 2020-07 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This Fourth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind available on this important subject.