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Pharmaceutical industry --- Biotechnology industries

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Pharmaceutical biotechnology. --- Biotechnology. --- Biotechnology industries. --- Biomedical industries --- High technology industries --- Chemical engineering --- Genetic engineering --- Biopharmaceutical technology --- Drugs --- Biotechnology --- Pharmaceutical technology --- Pharmaceutical biotechnology --- Biotechnology industries --- E-books

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"This book, the first in a new series that focuses on treaty implementation for sustainable development, examines key legal aspects of implementing the Cartagena Protocol on Biosafety to the UN Convention on Biological Diversity (CBD) at national and international levels. The volume provides a serious contribution to the current legal and political academic debates on biosafety by discussing key issues under the Cartagena Protocol on Biosafety that affect the further design of national and international law on biosafety, and analyzing recent progress in the development of domestic regulatory regimes for biosafety. It also examines the legal, political, economic, and practical challenges and solutions encountered in recent efforts to develop and implement domestic biosafety regulations, with a focus on developing countries. In the year of the fifth UN Meeting of the Parties to the Cartagena Protocol on Biosafety, at the signature of a new Nagoya-Kuala Lumpur Protocol on Liability and Redress, this timely book examines recent developments in biosafety law and policy"--

Biotechnology industries --- Biotechnology --- Transgenic organisms industry --- LAW / International. --- Law and legislation. --- Safety measures. --- Safety regulations. --- Convention on Biological Diversity --- Law / international. --- Law and legislation --- Safety measures --- Safety regulations

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The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. The biopharmaceutical market is among the most research-intensive market sectors globally. Clinical researchers face a multitude of public and private funding options with respect to bringing their idea or innovation to market. These funding options are continually changing and complex, and are expected to decr

Biopharmaceutics -- Research. --- Biotechnology industries. --- Pharmaceutical industry -- Finance. --- Pharmaceutical industry --- Biopharmaceutics --- Pharmacology --- Social Sciences --- Chemistry, Pharmaceutical --- Research --- Industry --- Investigative Techniques --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Chemistry --- Science --- Health Occupations --- Technology, Industry, and Agriculture --- Anthropology, Education, Sociology and Social Phenomena --- Biological Science Disciplines --- Natural Science Disciplines --- Technology, Industry, Agriculture --- Disciplines and Occupations --- Biomedical Research --- Economics --- Drug Industry --- Drug Discovery --- Health & Biological Sciences --- Pharmacy, Therapeutics, & Pharmacology --- Finance --- Research. --- Pharmacy --- Biopharmaceutics. --- Finance.

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An effective CMC regulatory compliance strategy for biologics and biopharmaceuticals can seem like a mystery.  Through means of this 2nd edition, this no longer needs to occur.  A great deal of thanks goes to two regulatory authorities – the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), who provide through their respective websites, an abundance of guidance, especially in the last several years.  So much has changed since the 1st edition of this book was published in 2004.  There are now additional manufacturing processes for producing commercial biopharmaceuticals – transgenic plant cell cultures and transgenic animals.  In addition to commercial recombinant proteins and monoclonal antibodies, there are now commercial cell-based medicines (cellular therapy) and DNA-based medicines (gene therapy).  Biosimilars are now on the marketplace in Europe, and under review for commercial approval in the USA.  Vaccine manufacturing has resurged due to the concerns of potentially pandemic mutated animal influenzas (e.g., swine flu, bird flu).  Strategic international regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including biopharmaceuticals, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality Systems (PQS).  The vast majority of the over 600 regulatory references listed in this book were either issued or updated since the release of the 1st edition.  All of these changes are the reason this updated edition includes not only biopharmaceuticals but also other biologics (e.g., live virus vaccines, human plasma-derived proteins, cell-based medicines, natural-sourced proteins) that have CMC regulatory compliance concerns and challenges in common with the genetically-engineered biologics (i.e., the biopharmaceuticals).      About The Author   John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.  Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry.  Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee.  Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)).

Medicine. --- Pharmaceutical biotechnology -- Quality control. --- Pharmaceutical biotechnology industry -- Law and legislation. --- Pharmaceutical biotechnology. --- Pharmaceutical technology. --- Pharmaceutical biotechnology industry --- Pharmaceutical biotechnology --- North America --- Technology --- Pharmacology --- Quality of Health Care --- Americas --- Technology, Industry, and Agriculture --- Biological Science Disciplines --- Health Services Administration --- Natural Science Disciplines --- Geographic Locations --- Technology, Industry, Agriculture --- Health Care --- Geographicals --- Disciplines and Occupations --- Quality Control --- Biopharmaceutics --- Guideline Adherence --- United States --- Health & Biological Sciences --- Pharmacy, Therapeutics, & Pharmacology --- Law and legislation --- Quality control --- Law and legislation. --- Quality control. --- Biopharmaceutical technology --- Drugs --- Biotechnology --- Biomedicine. --- Pharmaceutical Sciences/Technology. --- Biomedicine general. --- Pharmaceutical technology --- Biotechnology industries --- Pharmaceutical industry --- Clinical sciences --- Medical profession --- Human biology --- Life sciences --- Medical sciences --- Pathology --- Physicians --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Health Workforce --- Biomedicine, general.