At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, industry and regulatory stakeholders working across the scope of regulatory information will share their expertise on how to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related systems. The Forum presents four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Electronic Document Management, and Electronic Regulatory Submissions. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory information, and plenary sessions featuring regulatory intelligence updates by FDA and other regulatory authorities are offered each day.
TransCelerate’s Clinical Content & Reuse Initiative will feature an on-demand session entitled “Protocol Amendment Metadata Landscape Exploration,” led by Novartis’ Clinical Development & Analytics Associate Director Sharon McErlean.