DIA's Annual Canadian Meeting: New Reality / New Frontiers

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has evolved to respond to the increasingly global face of drug development, so that the benefits of international harmonization for better global health can be realized worldwide. From CTD to MedDRA to the many Quality guidelines now available, there has been significant revolution as a result of the organization's output. ICH has been particularly prolific of late producing some key and much anticipated documents that will have a major impact on regulators and industry. The panel will review some of the key developments and publications, the involvement of Health Canada, and some of the changes contemplated for ICH as it assesses new ways to add even more value in future.