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 life cycle management activities, as well as product registration information, labeling, CMC, and 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.
Life Sciences
Join industry leader V. “Bala” Balasubramanian for a DIA Virtual Round Table Discussion: RIM Working Group Update on Tuesday, June 16th at 1:15pm – 2:00 pm EDT. The discussion will include:
- Updates to the RIM white paper
- Creation of the RIM Reference Model Version 1.0
- Information on the recently launched AI in Regulatory Topic Group
Register here.
About DIA
DIA is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow.
Learn more about the DIA 2020 Annual Meeting here.
Learn more about Orion’s Life Sciences expertise and ReALM®.