Good Clinical Practice For Your Reference - Book 5
ICH - Efficacy Guidelines E3 – E15
ICH-E3: Clinical Study Reports ICH-E3 -
Structure and Content of Clinical Study Reports
ICH-E4: Dose-Response Information to Support
ICH-E5: Ethnic Factors in the Acceptability of
foreign Clinical Data
ICH-E6: Guideline for Good Clinical Practice
ICH-E7: Studies in Support of Special
ICH-E8: General Considerations for Clinical
ICH-E9: Statistical Principles for Clinical
ICH E-10: Choice of Control Group and Related
Issues in Clinical Trials
ICH-E11: Clinical Investigation of Medicinal
Products in the Pediatric Population
ICH-E12: Draft ICH Consensus Principle
Principles for Clinical Evaluation of New Antihypertensive Drugs
ICH-E14: The Clinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
ICH-E15: Definitions for Genomic Biomarkers,
Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
ICH Q8 Pharmaceutical Development
ICH Q9 Quality Risk Management
ICH Q10 Pharmaceutical Quality System
There is a Threat Lurking Online with the Power to Destroy Your Finances, Steal Your Personal Data, and Endanger Your Life.
In Spam Nation, investigative journalist and cybersecurity expert Brian Krebs unmasks the criminal masterminds driving some of the biggest spam and hacker operations targeting Americans and their bank accounts. Tracing the rise, fall, and alarming resurrection of the digital mafia behind the two largest spam pharmacies-and countless viruses, phishing, and spyware attacks-he delivers the first definitive narrative of the global spam problem and its threat to consumers everywhere.
Blending cutting-edge research, investigative reporting, and firsthand interviews, this terrifying true story reveals how we unwittingly invite these digital thieves into our lives every day. From unassuming computer programmers right next door to digital mobsters like "Cosma"-who unleashed a massive malware attack that has stolen thousands of Americans' logins and passwords-Krebs uncovers the shocking lengths to which these people will go to profit from our data and our wallets.
Not only are hundreds of thousands of Americans exposing themselves to fraud and dangerously toxic products from rogue online pharmacies, but even those who never open junk messages are at risk. As Krebs notes, spammers can-and do-hack into accounts through these emails, harvest personal information like usernames and passwords, and sell them on the digital black market. The fallout from this global epidemic doesn't just cost consumers and companies billions, it costs lives too.
Fast-paced and utterly gripping, Spam Nation ultimately proposes concrete solutions for protecting ourselves online and stemming this tidal wave of cybercrime-before it's too late.
"Krebs's talent for exposing the weaknesses in online security has earned him respect in the IT business and loathing among cybercriminals... His track record of scoops...has helped him become the rare blogger who supports himself on the strength of his reputation for hard-nosed reporting." -Bloomberg Businessweek
European Directive 2005/28/EC
Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
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.
European Directive 2005/28/EC