Learn best practices for managing serious adverse events (SAEs) and optimizing safety databases to improve workflows, ensure compliance, and enhance patient outcomes. Join pharmacovigilance expert Rebecca Noss to explore actionable strategies for modernizing SAE workflows and leveraging real-time data for smarter decision-making.

Key Takeaways:

• Define pharmacovigilance, AEs, SAEs, and pregnancies.

• Best practices for AE and SAE management.

• Managing special situations in adverse event reporting.

• A practical example of a completed SAE form.

Speaker:

Rebecca Noss brings 27 years of expertise in pharmaceutical clinical research and pharmacovigilance. She earned her MSc in Pharmacovigilance and Pharmacoepidemiology from the University of Bordeaux. Her specialties include Safety Assessment, Serious Adverse Event (SAE) Management, Safety Signal Management, and PV Risk Assessment. Rebecca has extensive experience with EMA Good Pharmacovigilance Practices (GVP), FDA REMS, post-marketing surveillance, and managing PV service providers. She is a trusted leader in developing PV documents and supporting compliance across regulatory frameworks.

About Cloudbyz:
Cloudbyz delivers advanced eClinical solutions for safety, compliance, and operational efficiency in clinical research. For more information visit www.cloudbyz.com