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Overview

*Short Course requires separate registration


Registration: 7:30–8:30AM


Currently, data is primarily kept in custody in documents. Life Science is moving away from this paper thinking and shifting towards structured data solutions (e.g. XEVMPD, IDMP, SPL, PQ/CMC, GInAS, ePI). The data is to be entered, stored and maintained in a Regulatory Information Management System (RIM). RIM data actually safeguards the patients by justifying the high quality of consistently produced drugs with an efficient benefit-risk ratio when used in accordance with the prescribing information. When managed correctly, the data continuous to fulfill this role as it is used for making informed decisions throughout the life cycle of a product. If not managed correctly, the data can become a source of failure which puts the patient at risk.

The RIM data undergoes a very dynamic continuous change during development and marketing phases. This Short Course puts the patients in context of the data, showing how life science professionals should to safeguard them during development and marketing of drugs, in a tool and company agnostic manner. It will touch upon all contributors and consumers of the regulatory information. It will also address dependencies for general capabilities like management of country requirements, data management, document management, and dossier management.


Learning objectives

At the conclusion of this session, participants should be able to:
  • Assess the definition of reliable information without the need for verification
  • Comprehend what (circular) end-to-end regulatory information management means, and how transactions of data are not standalone events
  • Identify who owns the data, documents, dossiers, where these are generated, and how these can be repurposed without re-work
  • Establish seamless regulatory processes of value-added steps in a tool agnostic way
  • Govern data to support interoperability of tools and streamline regulatory processes.