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Wednesday, June 29 • 4:00pm - 5:15pm
#373: Safety Reporting Pitfalls and Successes for Oncology and Hematology Drugs

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Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

On September 29, 2010, FDA issued a final rule amending its regulations governing expedited IND safety reporting requirements that revised the definitions used for reporting and clarified when to submit relevant and useful information in order to reduce the number of uninformative reports distributed by sponsors. An audit of randomly selected expedited safety reports submitted to FDA’s Office of Hematology and Oncology Products (OHOP) in 2015 revealed that the majority of submitted safety reports were uninformative. Submission of uninformative expedited safety reports by commercial sponsors of INDs continues to be a significant problem that can compromise detection of valid safety signals. Representatives from OHOP will present the current state of safety report submissions and efforts to modernize safety reporting.

Learning Objectives

Recognize the current state of safety report submissions to FDA’s Office of Hematology and Oncology Products (OHOP) based on a 2015 audit of safety reports as well as actions that OHOP has taken to guide sponsors to submit informative safety reports; Describe processes and procedures that the pharmaceutical industry has implemented to improve expedited safety reporting practices for hematology and oncology products; Describe OHOP-led initiatives to modernize safety reporting submission.

Chair

Tamy Kim, PharmD

Speaker

FDA Perspective
Suranjan De, MBA, MS

A Large Pharma’s Experience with Implementing the FDA Final Rule on Expedited IND Safety Reporting
Nina Stuccio, DO


Chair
avatar for Tamy Kim

Tamy Kim

Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER, FDA
Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →

Speakers
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
avatar for Nina Stuccio

Nina Stuccio

Therapeutic Area Lead, Clinical Safety and Risk Management, Oncology, and Bone, Merck Research Laboratories
Nina Stuccio, D.O. is the Therapeutic Area Lead, Oncology and Bone, Global Safety and an Industry member of the Clinical Trial Transformation Initiative (CTTI) IND Safety Advancement Project, focused on oncology trials to determine barriers and identify solutions for compliance with... Read More →

Wednesday June 29, 2016 4:00pm - 5:15pm EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Session