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Gebr. - Good Clinical Practice: A Question & Answer Reference Guide 2010
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2010, ISBN: 9781882615933

Letzte Aktualisierung am: 26.06.2018 07:10:41 Binding: Spiralbindung, Edition: Spi, Label: Barnett International, LLC, Publisher: Barnett International, LLC, medium: Sonstige Einbände, nu… Más…

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2010, ISBN: 9781882615933

Letzte Aktualisierung am: 15.11.2017 12:47:15 Binding: Spiralbindung, Edition: Spi, Label: Barnett International, LLC, Publisher: Barnett International, LLC, medium: Sonstige Einbände, nu… Más…

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Mark P. Mathieu:
Good Clinical Practice: A Question & Answer Reference Guide 2010 - Pasta blanda

2010

ISBN: 9781882615933

Barnett Educational Services, 2010 New. 700 pp. Spiral bound soft cover.. Spiral Bound. New., Barnett Educational Services, 2010

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Mathieu, Mark P.:
Good Clinical Practice: A Question & Answer Reference Guide 2010 - libro usado

2010, ISBN: 9781882615933

Parexel Intl Corp. SPIRAL-BOUND. 188261593X Very Good Condition. Five star seller - Buy with confidence! . Very Good., Parexel Intl Corp

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Mark P. Mathieu:
Good Clinical Practice: A Question & Answer Reference Guide, May 2010 - libro usado

2010, ISBN: 9781882615933

Parexel Intl Corp, 2010-05-28. Spiral-bound. Good., Parexel Intl Corp, 2010-05-28

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Detalles del libro
Good Clinical Practice: A Question & Answer Reference Guide 2010

Newly updated and expanded for 2010, this industry-leading GCP training and reference guide answers approximately 700 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP standards for drugs and biologics. While continuing with a U.S./FDA focus, this innovative reference pocket guide has now been expanded to provide even more information on not just US GCP, but international GCP issues in such regions and countries as the European Union, India, Latin America and Russia! Find out for yourself why more and more leading pharma and biotech companies are using this reference guide to educate their clinical professionals, trial auditors, and site staff on the many emerging complexities of GCP standards. The completely updated and expanded 2010 guide includes: * 60+ pages of all-new Q&As, including questions addressing emerging topics such as the use of social media in clinical trials, and the implications of IRB reviews of social media content used for patient recruitment. * A new chapter featuring exclusive interviews with Leslie Ball, M.D., director of CDER's Division of Scientific Investigations (DSI), and Joanne Less, M.D., director of FDA's Good Clinical Practice Program on the priorities and direction of the FDA's GCP enforcement programs. * Completely new and updated section featuring all the latest data and trends on the FDA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. * 200+ Q&As updated to reflect the very latest FDA guidances, regulations, comments, and developments. Read how the FDA will now be focusing more intently on sponsors' quality systems when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. In one pocket handbook, you'll have authoritative answers to hundreds of common and emerging questions, in 20+ GCP-related areas, right at your fingertips: * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections * Investigational Drug Accountability, Administration, and Labeling * Now includes a new section on GCP in Latin America! * Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!

Detalles del libro - Good Clinical Practice: A Question & Answer Reference Guide 2010


EAN (ISBN-13): 9781882615933
ISBN (ISBN-10): 188261593X
Tapa dura
Tapa blanda
Año de publicación: 2010
Editorial: Barnett International, LLC
Peso: 1,075 kg
Idioma: eng/Englisch

Libro en la base de datos desde 2010-10-29T05:17:11-05:00 (Mexico City)
Página de detalles modificada por última vez el 2019-07-17T06:37:25-05:00 (Mexico City)
ISBN/EAN: 188261593X

ISBN - escritura alterna:
1-882615-93-X, 978-1-882615-93-3
Mode alterno de escritura y términos de búsqueda relacionados:
Autor del libro: mathieu, barnett
Título del libro: ref 2010, good clinical practice guide, good question good answer


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