Upcoming Events

Designed for senior regulatory leaders, this program sharpens high-level communication, strategic decision-making, and risk management skills. It equips participants with proven techniques to align stakeholders, foster inclusion, and navigate complex, high-stakes environments with clarity and confidence.

This two-day interactive workshop is designed to equip regulatory and quality professionals with the essential knowledge to guide their organizations in navigating global Software as a Medical Device expectation.

Regulations change, customer expectations evolve, and businesses grow. Is your quality management system built to keep up? This webcast will explain how a global medical device contract manufacturer modernized its quality system to support multiple sites, diverse customer requirements in an increasingly complex regulatory landscape. Participants will get a reality check on today's quality challenges and what organizations should look for in an eQMS to support compliance, scalability, and long-term regulatory readiness.

This interactive four-hour workshop will teach you how PRRCs function at organizations small and large, internal or outsourced, manufacturer or authorized representative, and working with medical devices or IVDs.

This two-hour interactive workshop explores how AI helps regulatory teams spot emerging trends earlier, track policy shifts faster and turn regulatory intelligence into strategic action.

Discover how biomarkers are used across the clinical development pathway and what happens when biomarker strategy meets the European regulatory landscape. This interactive workshop combines essential learning on biomarker types, applications and development pathways with practical guidance on CTR and IVDR requirements. Through real world examples, case studies and group exercises, participants will learn how biomarker decisions affect trial design, regulatory strategy, documentation and operational delivery.

This three-day introductory workshop provides a practical foundation for understanding the regulatory landscape governing combination products in the US, European Union, and key global markets.

Learn how the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.