We are thrilled to announce that we submitted an abstract on behalf of IRISS to present ePI at the DIA RSIDM (Drug Information Association, Regulatory Submissions, Information and Document Management) and we are very pleased that by the end of the last year our session was confirmed and we managed to invite important and esteemed Speakers to the panel:
- Katja Pečjak, IRISS ePI Topic Group Lead, Subject Matter Expert at the EMA ePI Pilot Project; Billev Pharma East Ltd.
- Cesar Vinces, Director, Regulatory Innovation & International Policy; Accumulus Synergy, United States
- Hilmar Hamann, PhD, Head of Information Management Division; European Medicines Agency, Netherlands
- G. Scott Gordon, PhD, Senior Health Informatics Officer, OSP, CDER; FDA, United States
- Niklas Jaenich, PhD, RPh, Head of Global Labeling Operations and Digitization; Boehringer Ingelheim, Germany
- Jo English, VP and General Manager, Enterprise Technology; Calyx, United Kingdom (session chair)
Learning Objective : At the conclusion of this session, participants should be able to:
Understand the purpose of ePI & how it fits within regulatory ecosystem
Highlight the current state of ePI adoption globally
Describe the benefits of adopting ePI, best practices for implementation, and barriers to adoption
Explain how ePI interacts with global data standard initiatives & Why it matters
Electronic Product Information (ePI) represents a standardized approach expanding public access to precise, real-time information regarding summary of product characteristics, labeling, and package leaflets. Notably, ePI incorporates technical features that facilitates the use of common data standards and structured content exchanged using FHIR technology which enables seamless interoperability across the healthcare ecosystem. The EU member states adopted a common ePI standard and Japan has followed the same pathway. While a great first step, an opportunity to fundamentally transform how industry globally communicates labeling product information to patients and healthcare providers remains.
ePI brings significant benefits as it allows patients with timely and accurate insights into their prescribed therapies. Patients gain access to the most current prescribing guidelines such as dosage, side effects, and safety updates. Healthcare professionals (physicians and pharmacists) benefit by using structured content in ePI to support clinical decisions on treatments. ePI could also be integrated with electronic health records and e-prescribing systems, creating a seamless workflow for healthcare professionals, delivering a level of personalized medicine by highlighting the most effective therapy for patients with a specific diagnosis or clinical profile.
Recognizing the need for industry-wide coordination to make this paradigm shift a reality, this session will bring together a panel of leading voices in the ePI space. The moderated panel will foster engagement with participants into a range of topics and recommendations including the role of international data standards and exchange mechanisms for interoperability; impact of regional requirements on authoring structured content; strategies to overcome multilingual barriers in regulatory review; modernize legacy/emerging systems to allow for ePI processes; safeguarding personal identifiable information in patient-centric third-party applications.
Join us at RSIDM24 to hear valuable insights on the topic. #RSIDM24