Pharmacovigilance during the Pre-Approval Phases: An Evolving Pharmaceutical Industry Model In Response To ICH E2E, CIOMS VI, FDA and EMEA/CHMP Risk-Management Guidelines

Author： Hartford Craig G.  

Publisher： Adis International

ISSN： 0114-5916

Source： Drug Safety, Vol.29, Iss.8, 2006-01, pp. : 657-673

Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.

Previous Menu Next

Abstract

Related content

CIOMS and ICH Initiatives in Pharmacovigilance and Risk Management: Overview and Implications

By Tsintis P.   Edith La Mache  

Drug Safety, Vol. 27, Iss. 8, 2004-01 ,pp. : 509-517

Adis International

Access to resources Recommend Favorite

Risk management plans – one year on from the EMEA guidelines

By  

Reactions Weekly, Vol. 1, Iss. 1130, 2006-01 ,pp. : 3-4

Adis International

Access to resources Recommend Favorite

Risk Management Plans: One Year on from the EMEA Guidelines

By Stather Rosie  

International Journal of Pharmaceutical Medicine, Vol. 20, Iss. 6, 2006-01 ,pp. : 385-387

Adis International

Access to resources Recommend Favorite

Reporting of Deaths During Pre-Approval Clinical Trials for Advanced HIV-Infected Populations

By Johann-Liang Rosemary   James Andrea N.   Behr Virginia L.   Struble Kimberly   Birnkrant Debra B.  

Drug Safety, Vol. 28, Iss. 7, 2005-01 ,pp. : 559-564

Adis International

Access to resources Recommend Favorite

Highly Automated QT Measurement Techniques in 7 Thorough QT Studies Implemented under ICH E14 Guidelines

By Couderc Jean-Philippe   Garnett Christine   Li Mike   Handzel Robert   McNitt Scott   Xia Xiajuan   Polonsky Slava   Zareba Wojciech  

Annals of Noninvasive Electrocardiology, Vol. 16, Iss. 1, 2011-01 ,pp. : 13-24

Blackwell Publishing

Access to resources Recommend Favorite