Join us on the 21st of October, at 15:00 CET, to learn how your company can reach major time and cost savings as well as other business benefits using advanced text mining in the context of regulatory information management.
With the advance of IDMP implementation, data is becoming a key asset for the life sciences industry. Pharma companies are currently focusing on the heavy burden of initial IDMP data collection, but looking ahead, data maintenance will become their prevalent issue. This can only be tackled by maintaining the quality and integrity of data at all times. Making sure your data and content are always up to date, and FHIR messages are fully aligned with the content of submitted eCTD sequences, would bring major time and cost savings as well as other business benefits for the industry.
Advanced text mining technologies in the context of end-to-end RIM can support the current and future regulatory operations challenges alike. You are kindly invited to attend our webinar where some of those challenges, as well as their respective solutions, will be presented by Kelly Hnat from K2 Consulting, Hanno Ebsen from Averbis, and Renato Rjavec from Amplexor.
Kelly is a leader in RIM and IDMP with 25 years' experience in the biopharmaceutical industry leading IT, RIM, and Regulatory Operations organizations. Kelly is a globally recognized expert in IDMP and is a key subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS subteam, and the SPOR EU Implementation Guide Focus Groups. Additionally, she is a member of ISO TC215/WG6 (the ISO group responsible for the IDMP standards), is a member of the Core Research Team for the Gens & Associates World Class RIM survey, and serves as President and CEO of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards. Kelly is the founder of K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations.
Hanno holds a Master's degree in Psychology and has more than 18 years of experience in the life science industry. After 15 years in management at a consulting firm, he moved into AI product development for pharma. At Averbis, he is the first point of contact for customers in the Life Sciences sector.
As Director of Product Management, Renato is responsible for Amplexor’s Life Sciences product portfolio, focusing on customer value, innovation, quality and compliance. He has been with the company for 14 years, previously working on analysis, design, development and delivery of end-to-end regulatory and quality solutions for the Life Sciences industry.