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#302: From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care
Wednesday June 18, 2025 8:30am - 9:30am EDT
202A
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-610-L04-P; CME 1.00; RN 1.00

This session explores adverse event collection, processing, and actioning fundamentals as critical for integrating patient safety within teams, organizations, and the broader clinical research and patient care ecosystems.

Learning Objectives

Discuss improvements within the drug safety landscape to adverse event reporting, processing, decision-making, and communication; Appraise stakeholder roles in protecting patients and promoting public health; Discuss opportunities for adverse event stakeholders to collaborate across the health care continuum (clinical development, safety, advocacy).

Chair

Allison Cuff Shimooka, MBA

Speaker

Panelist
Rebecca Noss, MS

Panelist
Narayan Nair, MD

Panelist
Jeremy Jokinen, PhD, MS


Speakers
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
avatar for Narayan Nair

Narayan Nair

Associate Director Regulatory Affairs, Office of Biostatistics and Pharmacovigil, FDA, United States
Narayan Nair, M.D. is the Director of the Division of Pharmacovigilance in the Center for Biologic Evaluation and Research at the FDA. He oversees the Division that performs pharmacovigilance activities for vaccines and other biologic products regulated by FDA. Dr. Nair is a Board-Certified... Read More →
RN

Rebecca Noss

President, Global Pharmacovigilance Consultant, Noss Research Consulting, United States
Global Pharmacovigilance ‘PV’ Consultant with twenty-eight years of solid clinical research experience and post-marketing in pharmaceuticals. Excellence in providing safety strategy to product development teams, ensuring timely and high-quality execution of safety documents such... Read More →
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States
Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

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