A Consulting Team for Biopharmaceutical Companies

Category: Best Practice

  • Guidelines: Pharmacoepidemiology Practices (GPP)

    Tom

    Pharmacoepidemiologic studies provide valuable information about the health effects of healthcare products. The ISPE Guidelines for Good Pharmacoepidemiology Practice (GPP) are intended to assist investigators with issues pertaining to the planning, conduct, and interpretation of pharmacoepidemiologic research. This paper represents the fourth version and supersedes previous versions. While the overall structure and nature of the… Read more

  • Guidelines: ICH

    Tom

    ,

    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission… Read more