Author: | FDA, eregs and guides a Biopharma Advantage L.L.C. Company, Biopharma Advantage Consulting L.L.C. | ISBN: | 1230000220495 |
Publisher: | Biopharma Advantage Consulting L.L.C. | Publication: | February 9, 2014 |
Imprint: | Language: | English |
Author: | FDA, eregs and guides a Biopharma Advantage L.L.C. Company, Biopharma Advantage Consulting L.L.C. |
ISBN: | 1230000220495 |
Publisher: | Biopharma Advantage Consulting L.L.C. |
Publication: | February 9, 2014 |
Imprint: | |
Language: | English |
Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms.
In this issue you will find:
Consolidated Guidance: E6: Guidance for Industry - Good Clinical Practice: Consolidated Guidance - ICH April 1996.
Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application - August 2003.
Title 21- Part 11: Electronic Records; Electronic Signatures - Revised as of April 1, 2011.
Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms.
In this issue you will find:
Consolidated Guidance: E6: Guidance for Industry - Good Clinical Practice: Consolidated Guidance - ICH April 1996.
Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application - August 2003.
Title 21- Part 11: Electronic Records; Electronic Signatures - Revised as of April 1, 2011.