IDMP Textmining in global Regulatory Affairs
Co-hosted by Averbis & MAIN5, supported by Merck KGaA
Making use of AI technologies in Pharma R&D and adjacent areas has gained tremendous attention over the last couple of years. To date only limited solutions have succeeded to generate an added value for this highly regulated industry. Due the fact that pharma is still a highly document centric industry, integrated text mining solutions immediately proof a high value for pharma continuously shifting from unstructured to structured data across its regulated processes.
The FDA already provides clear guidance of how to qualify and validate knowledge-based systems assigned to supporting GxP related processes. New regulatory issues such as IDMP, reporting of an increasing number of adverse events as well the adequate pre-review of scientific papers name just a few topics that may gather your attention.
In this seminar we will present the possible applications of text mining in regulatory affairs with a focus on IDMP using specific case studies. In addition the challenge for aligning the associated regulatory processes and maintaining the organizational change will be discussed.