TGA Strategic Information Management Environment project update

The Strategic Information Management Environment (SIME) project is a TGA initiative to enhance the collection, management and reporting of TGA business information.

The delivery plan for the SIME project is now starting to take shape. A demanding schedule has been set, commencing with the delivery of a replacement for the Electronic Lodgement Facility scheduled for the first quarter of 2000. Other planned modules to be delivered include a replacement for the current Australian Register of Therapeutic Goods (ARTG), a new electronic facility for the lodgement of listed medical device applications, and a replacement for the current Adverse Drug Reaction System. The focus of each of these modules will be on providing better information to TGA staff as well as providing electronic access to information that will help our clients better conduct their business with the TGA.

Making sure that SIME is a useful tool for our clients is important to the TGA and we need your help to make sure that we fully understand your requirements. We are consulting widely with Industry Associations as well individuals who have expressed interest in a particular aspect of SIME. We are in the process of setting up a number of Special Interest Groups (SIGs) that will focus on particular issues relevant to SIME. These groups will encompass staff from within TGA as well as people external to the TGA. The purpose of these groups will be to ensure that consultation and communication is achieved in a planned, efficient and targeted manner. The groups will share information on their experiences and requirements and will communicate regularly via Email, teleconferences and bulletins. At present three Special Interest Groups have been identified to look at the following areas; security, electronic lodgement and information technology across the Industry.

We will keep you updated in future issues of the TGA News on progress of the project and how you can be involved.