Contract Manufacturing of Medicines

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Author :
Publisher : Kluwer Law International B.V.
ISBN 13 : 9041126422
Total Pages : 462 pages
Book Rating : 4.0/5 (411 download)

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Book Synopsis Contract Manufacturing of Medicines by : Magdalena Krekora

Download or read book Contract Manufacturing of Medicines written by Magdalena Krekora and published by Kluwer Law International B.V.. This book was released on 2008-01-01 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following: and• definition of and‘medicineand’ in different jurisdictions; and• categories of medicines; and• manufacturing and importation regulation in numerous jurisdictions worldwide; and• inspection regimes; and• good manufacturing practice (GMP); and• marketing authorization; and• manufacturing documentation; and• complaints and product recall; and• liability insurance; and• protection of trade secrets; and• data exclusivity and data protection; and• deficiencies and delays; and and• recognition and enforcement of judgements. A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.

Continuous Manufacturing for the Modernization of Pharmaceutical Production

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Author :
Publisher : National Academies Press
ISBN 13 : 0309487811
Total Pages : 69 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Continuous Manufacturing for the Modernization of Pharmaceutical Production by : National Academies of Sciences, Engineering, and Medicine

Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.

Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide

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Author :
Publisher : Pharmalicensing
ISBN 13 : 1905310110
Total Pages : 130 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide by :

Download or read book Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide written by and published by Pharmalicensing. This book was released on with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Art of Pharmaceutical Manufacturing

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Author :
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (987 download)

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Book Synopsis The Art of Pharmaceutical Manufacturing by : G.C. Hanford Manufacturing Company (Syracuse, N.Y.)

Download or read book The Art of Pharmaceutical Manufacturing written by G.C. Hanford Manufacturing Company (Syracuse, N.Y.) and published by . This book was released on 1994 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Manufacturing Handbook

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1384 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-21 with total page 1384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Pharmaceutical Outsourcing: Discovery and Preclinical Services

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Author :
Publisher : Lulu.com
ISBN 13 : 0984904905
Total Pages : 277 pages
Book Rating : 4.9/5 (849 download)

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Book Synopsis Pharmaceutical Outsourcing: Discovery and Preclinical Services by : William C. Stevens Jr.

Download or read book Pharmaceutical Outsourcing: Discovery and Preclinical Services written by William C. Stevens Jr. and published by Lulu.com. This book was released on 2011 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Outsourcing: Discovery and Preclinical Services is the first in a series on pharmaceutical outsourcing. This first book is written for all practitioners in the pharmaceutical and biotech world and is about managing projects in drug discovery and preclinical development. The purpose envisioned by the authors and editors is to provide an understanding of how outsourcing works from the perspective of sponsor, internal customer, service provider, outsourcing service marketplace, principal investigator, project leader, and consultant. The authors of this book and the companies they represent hail from the Americas, Europe, Asia, and Australia, underscoring the fact that drug discovery is an international effort. The scope of the businesses covered include the one-person consulting company through to a sponsor among the largest in the industry. Written in the styles unique to each author, the reader will enjoy getting into the minds of the writer. Our intention is to provide a story for each aspect of the process as you move from target validation, genomic profiling, screening, medicinal chemistry, modeling and informatics, safety evaluation, therapeutic target confirmation, through to protecting the results of the research, the intellectual property. Emerging trends in drug discovery support a rapidly growing business model in outsourcing, the virtual pharma company. In recognition of this important element are several success stories and learnings on arbitraging risks in discovery. Outsourcing provides the ultimate flexibility in managing projects that may quickly grow, progress in directions unanticipated, or fail early. Last but not least, this book provides insights in working with companies outside your region, with business cultures unfamiliar or unknown. Relationship building is about understanding your sponsor or customer in their cultural space and being able to establish the rapport for clear and open communications. Priceless!

Strategies Used by Adults to Reduce Their Prescription Drug Costs

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Author :
Publisher :
ISBN 13 :
Total Pages : 12 pages
Book Rating : 4.3/5 (121 download)

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Book Synopsis Strategies Used by Adults to Reduce Their Prescription Drug Costs by : Robin A. Cohen

Download or read book Strategies Used by Adults to Reduce Their Prescription Drug Costs written by Robin A. Cohen and published by . This book was released on 2015 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Manufacturing of Pharmaceutical Proteins

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 3527683089
Total Pages : 458 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Manufacturing of Pharmaceutical Proteins by : Stefan Behme

Download or read book Manufacturing of Pharmaceutical Proteins written by Stefan Behme and published by John Wiley & Sons. This book was released on 2015-03-20 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.

Making Medicines Affordable

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Author :
Publisher : National Academies Press
ISBN 13 : 0309468086
Total Pages : 235 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine

Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Key Players in Pharmaceutical Contract Manufacturing

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Author :
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (83 download)

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Book Synopsis Key Players in Pharmaceutical Contract Manufacturing by :

Download or read book Key Players in Pharmaceutical Contract Manufacturing written by and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical contract manufacturing industry continues to grow, driven by mounting industry pressures. The highly competitive nature of the industry has been driving consolidation and companies are increasingly offshoring to emerging markets.

Contract Research and Manufacturing Services (CRAMS) in India

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Author :
Publisher : Elsevier
ISBN 13 : 1908818166
Total Pages : 251 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis Contract Research and Manufacturing Services (CRAMS) in India by : Milind Antani

Download or read book Contract Research and Manufacturing Services (CRAMS) in India written by Milind Antani and published by Elsevier. This book was released on 2012-10-31 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications. Simple and accessible presentation using tables, charts and diagrams Practical tips from leading practitioners Inclusion of relevant case laws and other legal considerations

Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products

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Author :
Publisher :
ISBN 13 : 9789354583056
Total Pages : 0 pages
Book Rating : 4.5/5 (83 download)

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Book Synopsis Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products by : Chandrasekhar Panda

Download or read book Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products written by Chandrasekhar Panda and published by . This book was released on 2021-07-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Book contains 11 Modules of Good Manufacturing Practices (GMP) for Pharmaceutical Products which will be very useful to the persons working in Pharmaceutical Industry and this can be used as a cGMP Training modules in Pharmaceutical Companies which is a basic training requirement for every employee. The Modules are Module-1 Plant Premises Module-2 Plant Equipment's Module-3 Plant Production Module-4 Plant Personnel Module-5 Plant Training, Documentation and Personnel Hygiene Module-6 Plant Quality Control Module-7 Qualification and Validation Module-8 Pharmaceutical QMS Module-9 Plant Self-Inspection and Audit Module-10 Plant Complaints and Product recall Module-11 Plant Contract Manufacturing and Contract Analysis

Contract Pharmaceutical Manufacturing, Research and Packaging

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Author :
Publisher :
ISBN 13 : 9781596237889
Total Pages : pages
Book Rating : 4.2/5 (378 download)

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Book Synopsis Contract Pharmaceutical Manufacturing, Research and Packaging by : BCC Research

Download or read book Contract Pharmaceutical Manufacturing, Research and Packaging written by BCC Research and published by . This book was released on 2011-09 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Continuous Biomanufacturing

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Publisher : John Wiley & Sons
ISBN 13 : 3527340637
Total Pages : 628 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Continuous Biomanufacturing by : Ganapathy Subramanian

Download or read book Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2017-12-26 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.

Current Good Manufacturing Practices

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Author :
Publisher : PharmaLogika Books
ISBN 13 : 9781937258177
Total Pages : 688 pages
Book Rating : 4.2/5 (581 download)

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Book Synopsis Current Good Manufacturing Practices by : Mindy J. Allport-Settle

Download or read book Current Good Manufacturing Practices written by Mindy J. Allport-Settle and published by PharmaLogika Books. This book was released on 2018-02-20 with total page 688 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Regulations and Associated Guidance Documents: - Code of Federal Regulation Title 21 Overview - Part 11 Electronic Records; Electronic Signatures (21CFR§11) and Guidance for Industry - Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community (21CFR§26) - Part 200 Drugs: General (21CFR§200) - Part 207 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and The National Drug Code (21CFR§207) - Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General (21CFR§210) - Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (21CFR§211) - Part 600 Biological Products: General (21CFR§600) - Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (21CFR§807) - Part 820 Quality System Regulation (21CFR§820) - Part 11, Electronic Records; Electronic Signatures - Scope and Application - Guidance for Industry and FD A Staff: Current Good Manufacturing Practice Requirements for Combination Products - Guidance for Industry: CGMP for Phase 1 Investigational Drugs - Process Validation: General Principles and Practices - PAT - A Frame work for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance - Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations - Contract Manufacturing Arrangements for Drugs: Quality Agreements - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP - Formal Dispute Resolution: Sponsor Appeals Above the Division Level Reference Tools: - Glossaries combined in one location - GMP Keyword Index for 21CFR211 - Combined Index for all documents

Strategic Supply Chain Management 2E (PB)

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Author :
Publisher : McGraw Hill Professional
ISBN 13 : 0071813098
Total Pages : 320 pages
Book Rating : 4.0/5 (718 download)

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Book Synopsis Strategic Supply Chain Management 2E (PB) by : Shoshanah Cohen

Download or read book Strategic Supply Chain Management 2E (PB) written by Shoshanah Cohen and published by McGraw Hill Professional. This book was released on 2013-06-21 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise For Strategic Supply Chain Management: "This book shows convincingly that a robust supply chain strategy is critical for business success in today's uncertain economic environment. Cohen and Roussel explain not only what makes for a good supply chain strategy but also how to put that strategy into practice." -- Jim Miller, VP, Worldwide Operations, Google "Strategic Supply Chain Management loudly and clearly makes the case that successful companies' supply chain strategies are closely aligned with their competitive differentiation and operating models. The book uses in-depth examples that bring these concepts to life and demonstrate that one size doesn't fit all. Anyone who thinks operations is just another corporate function needs to read this book." -- Manish Bhatia, SVP, Worldwide Operations, SanDisk "The advent of global marketplaces, heightened competition, accelerated pace of product innovation, and fast-changing customer preferences have increased the impact of the supply chain on company profitability and long-term success. But cultural challenges to successful supply chain design remain. Cohen and Roussel's book provides a platform for addressing these challenges and is recommended reading for chief executives, strategy professionals, and supply chain practitioners." -- Martin Roper, Chief Executive Officer and President, Boston Beer "The authors present a straightforward path for developing and deploying a global supply chain strategy that addresses the priorities of today's executive management teams." --Hau Lee, Thoma Professor of Operations, Information and Technology, Stanford Graduate School of Business The classic guide to supply chain strategy--re-created to help business leaders gain an advantage in today's volatile, globalized arena The global landscape has changed dramatically since the first edition of Strategic Supply Chain Management established itself as the authority on creating value and achieving competitive advantage from the supply chain. Shorter economic cycles, more-frequent natural disasters, higher costs in low-cost countries, more-restricted access to working capital, and greater focus on sustainability have made effective supply chain management much more challenging--and much more critical to the bottom line. This second edition is your answer to gaining a strategic advantage in the face of these challenges. Drawing on dozens of new company examples as well as cutting-edge benchmarking research, it shows you how to make your supply chains more agile, flexible, and resilient. With 80 easy-to-read tables and diagrams, this fully revised book explains how to: Develop a supply chain strategy that will help you realize your business goals Design a process architecture that maps out the activities of the end-to-end supply chain Create the most effective supply chain organization Build the most beneficial relationships with your supply chain partners Use metrics to assess and drive business success Implement transformational change See how today's best supply chain strategies work in all-new profiles of BASF, Essilor, Haier, Kaiser Permanente, Lenovo, and Schlumberger. Find out what these industry leaders are doing to get the greatest value out of their supply chains. When value depends on how well you deliver, you need Strategic Supply Chain Management, Second Edition.

Contract Pharmaceutical Manufacturing, Research and Packaging

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Author :
Publisher :
ISBN 13 : 9781596235281
Total Pages : pages
Book Rating : 4.2/5 (352 download)

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Book Synopsis Contract Pharmaceutical Manufacturing, Research and Packaging by : BCC Research

Download or read book Contract Pharmaceutical Manufacturing, Research and Packaging written by BCC Research and published by . This book was released on 2009-10 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: