Webinar: Dr Susan Fitzpatrick - Safety That Scales: Practical Clinical Safety Strategies for Early-Stage Biotechs
Event Details
Early-stage biotech companies face intense pressure to move quickly into the clinic, yet safety remains the most common source of critical findings, delays, and regulatory scrutiny in early trials. This webinar draws on practical experience supporting emerging sponsors and expands on themes from our white paper, Safety That Scales: Clinical Safety Strategies for Biotech Startups in Early Clinical Trials. We will demystify how drug safety operates in early-phase development, including the distinct roles of pharmacovigilance, medical monitoring, and risk management. Attendees will gain clarity on sponsor responsibilities, SAE and SUSAR reporting, safety governance models suitable for small organizations, and how to maintain effective CRO oversight. Through real-world case studies including first-in-human signal escalation and pre-inspection remediation we will highlight common pitfalls faced by academic spin-outs and first-time sponsors. Participants will leave with a practical safety readiness checklist and key questions leadership teams should be asking to build scalable, inspection-ready safety frameworks from day one.
Speaker:
Dr Susan Fitzpatrick is a Clinical Pharmacovigilance Consultant at Signal Pharma Experts, where she supports early-stage biotech and pharmaceutical companies in building scalable, inspection-ready clinical safety frameworks. With over 10 years of experience in preclinical and clinical development, she specializes in patient safety across first-in-human and later-phase trials. Susan has guided clinical programs from study start-up through close-out and regulatory submission, with expertise in SAE and adverse event management, safety data review, signal detection, risk mitigation, and preparation of key safety documents including Investigator’s Brochures and safety management plans. She also supports inspection readiness and serves as a subject matter expert during audits and regulatory inspections. She holds a BSc (Honours) in Pharmacology and a PhD in Medical Science from University College Dublin.
more