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Monday, June 27 • 10:45am - 12:00pm
#140: Understanding, Developing, and Implementing an Anticipated Events Review Process: Adoption of the FDA IND Rule on Safety Reporting Requirements

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-576-L05-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how to understand, develop, and implement the review/reporting process for events considered anticipated based upon the disease under study which is an important new procedure within clinical development. Attendees will also learn through the examination of case studies clarifying issues leading to uninformative safety reporting.

Learning Objectives

Describe barriers to implementation of the FDA Rule; Clarify the FDA Rule and guidance in order to reduce the number of uninformative safety reports; Recognize the end to end process of the aggregate review and reporting of Anticipated Events; Convert the knowledge of the process into a tangible approach for adoption; Identify how to guide an organization to develop and implement a process; Identify opportunities for improving the quality and efficiency of IND safety reporting processes.

Chair

Robert (Mac) Gordon, MS

Speaker

Using Case Studies to Facilitate Implementation of the FDA Rule for IND Safety Reporting
Marsha Millikan

FDA Perspective
Jonathan P. Jarow, PhD

One Company's Approach to Developing and Implementing an Anticipated Events Review Process
Robert (Mac) Gordon, MS



Chair
avatar for Robert (Mac) Gordon

Robert (Mac) Gordon

Biostatistician, Janssen Pharmaceutical Companies of Johnson & Johnson
Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career. Currently he is a clinical trial and clinical safety statistician at J&J. His clinical focus has been immunology for the past 10 years.

Speakers
avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor to the Center Director, CDER, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology Products. Prior to joining the FDA he was Professor of Urology, Pathology, Radiology, and Molecular Biology & Biochemistry at Johns Hopkins University.
avatar for Marsha Millikan

Marsha Millikan

Advisor, Expedited Reporting Global Patient Safety, Eli Lilly and Company
18 years of pharmaceutical drug safety experience. Currently oversees global PV expedited reporting business processes. She supported multiple projects including the FDA IND rule changes, database updates, creation of an investigator line listing report, & EU GVP process updates. Previously she worked in PV surveillance, case management, quality, & call center AE reporting. Before pharma, she worked as a hospital clinical pharmacist consulting on... Read More →


Monday June 27, 2016 10:45am - 12:00pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA