Systematic diagnosis of pressing industry challenges—regulatory, scientific, operational, digital—and mapping state-of-the-art digital solutions or IT best practices for each.
Learners will be able to identify key pain points for pharma stakeholders and propose IT-enabled solutions or project archetypes that address them efficiently and compliantly.
ALCOA+ principles, audit trails, Part 11, integrated QMS.
Cyber defense, privacy-by-design, threat modeling, GDPR/HIPAA.
Decentralized trial platforms, ePRO, wearable data, remote site tools.
Mobile reminders, digital coaching, self-report apps.
Patient assistance platforms, transparency tools, value-based payment.
Serialization, IoT monitoring, blockchain, predictive logistics.
Digital training, change champions, agile transformation.
Automated compliance software, eCTD, labeling, regional variations.