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#653: Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII Across the Product Lifecycle
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
115AB
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-26-637-L04-P; CME 1.00; RN 1.00

Benefit-risk planning is recommended by both FDA and CIOMS XII but it is complex to implement. In this forum, a panel will discuss the importance of strategically conducting continuous benefit-risk planning for development programs.

Learning Objectives

Demonstrate the need for a continuous approach to benefit-risk planning; Recognize the risks of failing to conduct benefit-risk planning; Identify ways to introduce benefit-risk planning into drug development

Chair

Claudia Ana Ianos, MD

Speaker

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Robyn Bent, BSN, MS, RN

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Diana Morgenstern, MD, FACP

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Megan Aragon, MBA

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Bennett Levitan, MD


Speakers
avatar for Megan Aragon

Megan Aragon

Technology Services Administrator, East Texas Lighthouse for the Blind, United States
Megan Aragon is the Technology Services Administrator at East Texas Lighthouse for the Blind, where she leads Assistive Technology (AT) strategy and training initiatives. A native AT user, she brings lived experience with vision loss to systems-level program design and service delivery... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
Robyn Bent, MS, RN, is the director of the Patient-Focused Drug Development (PFDD) Program in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). . Ms. Bent also serves as an FDA representative to the Management Committee of the International... Read More →
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Senior Director, Safety Risk Management Lead, Pfizer, United States
Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 15 years of... Read More →
avatar for Bennett Levitan

Bennett Levitan

Executive Director, Benefit-Risk Assessment / Epidemiology, Johnson & Johnson, United States
Bennett Levitan, MD-PhD is Executive Director Benefit-Risk (B-R)/Epidemiology at Johnson & Johnson. He introduced state of the art patient-focused B-R to J&J and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the... Read More →
DM

Diana Morgenstern

Head, Real World Evidence and Outcomes Research, Viatris, United States
Diana Morgenstern, MD, FACP is a general internist whose varied career includes depth and breadth in clinical practice, medical education, and strategic approaches to pharmaceutical industry medical affairs, including real world evidence generation to address care gaps. Dr. Morgenstern... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   01: ClinSafety-PV-RM, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

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