News & Events

  • September 12-13, 2016

    i4i attends DIA Global Labeling 2016, for "Essential Updates on Worldwide Regulations and Guidelines". A conference for regulators and industry to update their knowledge of local and global labeling-related policies, and to share processes, tools, and approaches to ensure effective and compliant labeling. Stop by the exhibition area and meet the i4i team!

  • September 2, 2016

    The FDA is now accepting REMS (Risk Evaluation and Mitigation Strategy) submissions in the Structured Product Labeling (SPL) format. Once the final guidance is issued, the FDA intends to mandate the REMS SPL submission type, but for now the new submission format remains voluntary.

    For the first year, during this voluntary submission period, any sponsors that begin submitting REMS in SPL can request assistance from the FDA in creating the REMS Summary section of their REMS submission. The FDA believes the initiative will improve the sharing and integration of Risk Evaluation and Mitigation Strategies (REMS) with pharmacy and hospital IT systems.

    In partnership with two clients, i4i participated in the FDA's REMS SPL pilot and is now supporting all clients that are ready to begin creating REMS SPL submissions. Once the final guidance is published, i4i has plans to release an update to A4L that supports the REMS SPL creation. Find out more about A4L here. Or click here to dig deeper into the FDA's REMS SPL initiative.

  • May 23-25, 2016

    i4i is in Leiden joining the conversation on how to "Stop Paper Thinking".
    The 16th DIA Conference on European Electronic Data Management and eHealth Topics is the only conference focused on Electronic Content Management that brings together both regulatory agencies and industry to discuss how to reduce reliance on paper documents. If you are attending the conference, stop by the exhibition area and meet the i4i team!

  • April 6-8, 2016

    DIA Euro bannerThe 28th annual DIA EuroMeeting is in Hamburg and i4i is there.
    With 14 themes, pre-conference tutorials and hot top sessions there will be much to learn, and discover and plenty to talk about.
    Make sure you stop by and meet the team at booth F11!

  • February 8-10, 2016

    i4i joins the DIA RSIDM in North Bethesda, MD.DIA RSIDM banner
    Covering topics through four tracks; Electronic Regulatory Submissions (ERS), Regulatory Information Management (RIM) Business, RIM Technology, and Electronic Document Management (EDM), this forum touches on i4i's core strengths and expertise creating innovative solutions for business operation processes in the Life Sciences sector. We look forward to discussing how structured content solutions can streamline your regulatory processes and requirements. If you are going to be there, take a moment to connect with our team at booth 302!

  • January 2016

    Best Wishes from i4i! 2015 was another great year and it continues to be a pleasure helping our valued clients reach their goals year after year. As new regulations and opportunites unfold we look forward to contributing to further successes in 2016.