Regulatory Submissions, Information, and Document Management Forum

Feb. 8, 2021 – Feb. 10, 2021  • Virtual

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Regulatory information is arguably the most valuable asset of a pharmaceutical, biotech, or medical device company. It includes data, meta-data, documents, and other forms of information about regulatory and submission intelligence, regulatory authority submission and reporting requirements, submission plans for new products, and lifecycle management activities, as well as product registration information, labeling, CMC, safety submissions, communications from health authorities, and more.

How regulatory information is managed has a profound impact on operational efficiency across the whole organization, on data quality, and ultimately on the company’s ability to meet the needs of patients. As global regulatory requirements, technology, data sources, and data standards evolve, the importance of sound regulatory information management becomes even greater.

DIA’s Regulatory Submissions, Information, and Document Management Forum, February 8-10, brings together industry and regulatory stakeholders working across the scope of regulatory information to examine current 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.