VICH 1 - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook VICH 1 write by . This book was released on 2000. VICH 1 available in PDF, EPUB and Kindle.
First Conference on International Harmonisation of Veterinary Medicinal Products, 16-18 November 1999--Brussels, Belgium
First Conference on International Harmonisation of Veterinary Medicinal Products, 16-18 November 1999--Brussels, Belgium - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook First Conference on International Harmonisation of Veterinary Medicinal Products, 16-18 November 1999--Brussels, Belgium write by European Commission. This book was released on 2000. First Conference on International Harmonisation of Veterinary Medicinal Products, 16-18 November 1999--Brussels, Belgium available in PDF, EPUB and Kindle.
FDA Veterinarian
FDA Veterinarian - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook FDA Veterinarian write by . This book was released on 2000. FDA Veterinarian available in PDF, EPUB and Kindle.
Single-Use Technology in Biopharmaceutical Manufacture
Single-Use Technology in Biopharmaceutical Manufacture - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Single-Use Technology in Biopharmaceutical Manufacture write by Regine Eibl. This book was released on 2019-07-18. Single-Use Technology in Biopharmaceutical Manufacture available in PDF, EPUB and Kindle. Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Current Challenges in Pharmacovigilance
Current Challenges in Pharmacovigilance - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Current Challenges in Pharmacovigilance write by World Health Organization. This book was released on 2001-01-01. Current Challenges in Pharmacovigilance available in PDF, EPUB and Kindle. In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
