Regulatory Submissions, Information, and Document Management Forum

Don’t let traditional practices and legacy processes hold you back. The regulatory submission process is complex, time-consuming and involves many participants. If your submission contains mistakes or inaccurate information, your product’s future may be in jeopardy. The key to success is superb submission planning. During this session we will review the basics of effective and timely submissions, the need for team collaboration, and the use of technology. The planning process begins with regulatory strategy, identifying key components and deliverables required, including health authority interactions, develop a project plan with sufficient detail to provide guidance to the submission team, while reaching the goal. In this session we will provide best practice ideas for the techniques, tools and how to bring it all together in a plan that gets it right the first time.