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Tuesday, June 18 • 10:00am - 11:00am
#218: Long-Term Safety of Approved Medicines: Approaches for Identifying, Characterizing, and Quantifying Delayed Adverse Events

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-569-L04-P; CME 1.00; RN 1.00

This forum will hear from regulators, industry, vendors, and the academic community on how each has approached the generation of long-term safety data on a hypothetical approved medicine with a risk of delayed adverse events.

Learning Objectives

Compare strengths and weaknesses of different approaches for evaluating long-term safety particularly when delayed adverse events are a potential risk; Identify fit-for-purpose, longitudinal data sources to answer regulator research objectives for long-term follow-up studies.

Chair

Steven M. Weisman, PhD

Speaker

Panelist
Claudia A Salinas, PhD

Panelist
Naomi Boxall, PhD

Panelist
Vera Ehrenstein, DrSc, MPH

Panelist
Gerald Dal Pan, MD, MHS


Speakers
avatar for Steven Weisman

Steven Weisman

Global President, Clinical and Regulatory, Lumanity Inc, United States
Over the years, Dr. Weisman has built a stellar reputation as a regulatory and medical affairs consultant helping clients achieve productive relationships with regulatory authorities in the United States and around the world. Dr. Weisman has played a pivotal role working on important... Read More →
avatar for Naomi Boxall

Naomi Boxall

General Manager, PHARMO Institute, Netherlands
Naomi is General Manager at PHARMO and INSZO and is accountable for a portfolio of RWE projects using health data from various sources to support drug development and commercialization for global life science sector. With over 20yrs experience from a breadth of epidemiology topics... Read More →
avatar for Vera Ehrenstein

Vera Ehrenstein

Professor, Department of Clinical Medicine, Dept of Clinical Epidemiology, Aarhus University, Denmark
Vera Ehrenstein is professor of pharmacovigilance at the Department of Clinical Epidemiology, Aarhus University, Denmark. She has more than 20 years' experience as an epidemiologist, including more than 15 years' experience leading multinational postauthorisation safety studies of... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
CS

Claudia Salinas

Senior Director, GPS Pharmacoepidemiology, Eli Lilly and Company, United States
Dr. Salinas is a pharmacoepidemiologist, with a doctorate in Epidemiology from the University of Washington, currently working in late stage and postmarketing clinical development at Eli Lilly and Company. She has expertise in real-world data analysis and causal inference focusing... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Forum