#140: Understanding, Developing, and Implementing an Anticipated Events Review Process: Adoption of the FDA IND Rule on Safety Reporting Requirements
Chair
Director, Biostatistics, Johnson & Johnosn Innovative Medicines, United States
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, including membership in several multi-disciplinary...
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Speakers
Senior Medical Advisor, 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...
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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...
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Monday June 27, 2016 10:45am - 12:00pm EDT
108A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA