Menu Back to Poster-Presentations-Details

P115: Electronic Product Information (ePI) Pilots Across LATAM: A Sponsor’s Digital Transformation Study

Poster Presenter

Jorge Azar

Senior Area Regulatory Director for Latin America
AstraZeneca
United States

Objectives

Present the ePI pilot program design and its roll out across Latin America, the strategies, and learnings of implementation in different and diverse regions like Mexico, Brazil, Central America, Caribbean, and Andean. ePI digital technology can be patient-centric and shape the regulatory environment

Method

The 2023 ePI Pilot was held across Latin America. It involved the engagement of regulatory authorities, healthcare professionals, Manufacturing and Patients; regulatory framework mapping, establishing labeling repository system and functionality, and placing pilot products in the market.

Results

The hypothesis of the pilot was if it was feasible to implement ePI across different and diverse Latin American pharmaceutical markets with or not respective legislation. Launching pilots is one way to understand how an environment responds to a new trend setter like ePI. The pilot across the different markets such as Mexico, Brazil, Central America, Caribbean, and Andean allowed us to collate data on which products the ePI pilot can be applied; how processes should be adapted so that different stakeholders can participate from manufacturing to the patient; and what digital systems can be built to facilitate ePI roll out end to end. Present data on where ePI pilots were hybrid as in paper and electronic format; and how engagements differed amongst participating National Regulatory Authorities. Analytics will be presented on the types of products rolled out and the decision making behind each product type selection. Findings will be presented on how patient can tailor the access to ePI as per their needs and in a patient-friendly electronic format while increasing readability. Also, the study will demonstrate how gaining experience through the pilot has allowed to shape the regulatory environment with an indicator such as an ePI guideline publication.

Conclusion

As we are moving towards digitalization and speeding up in sharing the latest information the Electronic Product information (ePI) for human medicines is a key example of digitalization in Healthcare offering benefits such as accessibility to updated version of product information (PI), accelerate the availability of new medicines, eliminates of non-compliance risk related to hardcopy PI implementation, optimize resources at agency and industry level, increase the possibility to share packs across different countries with multiple languages including a clear contribution on sustainability This Latin American ePI pilot case study shows: a) the importance for patients and Healthcare Professionals in LATAM to be introduced to digital healthcare. b) designing the ePI pilot implementation in parallel with paper allowed for getting the experience and advocate for its use across the region and be an enabler for a change in the regulation. c) understating the practicalities and lessons learnt of establishing such pilots across distinctively different markets