Agenda

02:30 AM

Opening

Health Cluster Portugal
EIT Health Innostars

02:35 AM

Preclinical evidence behind the guidelines

• What Preclinical Evidence Is Expected - and at What Stage.
• Linking Preclinical Evidence to the General Safety and Performance Requirements (GSPR).
• Usability Studies as Part of Preclinical Evidence.

Speaker: Ana Brito (Coordinator of the Medical Devices Regulatory Support Unit, IPN)

03:00 AM

Clinical Evaluation Strategy

• Building a Risk‑Aligned Clinical Evaluation Strategy.
• The Art of Literature: Building a Robust Clinical Evaluation Report (CER).
• Integrating PMS, PMCF and Evidence Generation in a Clinical Evidence Lifecycle.

Speaker: Inês Urbano (Medical Devices Regulatory Affairs Consultant, IPN)

03:30 AM

Early clinical validation

• The Sweet Spot: When Early Validation Drives Real Progress.
• ISO 14155 fundamentals for early feasibility and pilot studies.
• Designing high‑quality early clinical studies: Endpoints, Methodology & Scalable Evidence.

Speaker: Maria Nascimento (Testing and Validation Sub-Unit Coordinator, IPN)

04:00 AM

Q&A Session

04:10 AM

Closing  

Health Cluster Portugal
EIT Health Innostars