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Session 4, Track C: Patient Support Programs and Drug Safety: Compliance, Reporting, and Optimization
Session Chair(s)
Ricardo Pasquel Cook, MD
Safety Team Lead
Pfizer Inc., Canada
Anna Bussel, MPharm
Vice President Pharmacovigilance and Medical Information
ClaroPV Services Inc, Canada
As Patient Support Programs (PSPs) become increasingly integral to patient care - especially with the rise of injectable therapies - ensuring pharmacovigilance (PV) compliance and data quality is more critical than ever. This session explores the evolving PSP landscape in Canada and the U.S., highlighting key differences, challenges, and opportunities. Experts will share proactive strategies for designing compliant post-market surveillance workflows, optimizing AE reporting, and improving collaboration between PV and commercial teams. Attendees will gain practical insights into monitoring PSP-provider compliance, enhancing data quality, and aligning workflows with regulatory expectations to safeguard patient safety.
- Patient Supports Programs and Drug Safety
Riti Singh, Bayshore Healthcare (Bayshore Specialty Rx Ltd.) - Good Pharmacovigilance Practices Audits Of Patients Support Programs
Agnes Jankowicz, Claropv Services Inc. - Patient Support Programs and Safety Reporting: An Industry Perspective
Nadia Latif, Ipsen Biopharmaceuticals Canada Inc
Learning Objective : - Compare Canadian vs. U.S. regulatory expectations for Patient Support Programs (PSPs), using regional examples to highlight major differences
- Outline effective strategies to design and monitor PSP workflows that improve adverse event (AE) reporting quality and ensure compliance
- Apply KPIs to evaluate PSP effectiveness in pharmacovigilance and suggest enhancements for organizational processes
Speaker(s)
Patient Supports Programs and Drug Safety
Riti Singh, PharmD, MBA
Bayshore Healthcare (Bayshore Specialty Rx Ltd.), Canada
National Director - Scientific Affairs, Quality, Ethics and Compliance
Speaker
Nadia Latif, MS
Ipsen Biopharmaceuticals Canada Inc., Canada
Senior Manager, Pharmacovigilance
Good Pharmacovigilance Practices Audits Of Patients Support Programs
Agnes Jankowicz, MS
ClaroPV Services Inc, Canada
Vice President, Pharmacovigilance
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