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Monday, June 25 • 11:00am - 12:15pm
#118: How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-530-L04-P; CME 1.25; IACET 1.25; RN 1.25

Why has the utilization of real-world data to assess efficacy lagged relative to the application of real-world safety data? Important questions must be addressed concerning efficacy data quality, endpoint surrogacy, and overall study design. This session will bring together global regulators, healthcare technologists, and drug developers to tackle the practical challenges, so that real world evidence can be more optimally incorporated into regulatory decision making.

Learning Objectives

Identify how real-world data must be collected, analyzed and reported in order to be useful in regulatory decision-making beyond the post-market safety surveillance setting.

Chair

Jeffrey N. Stuart

Speaker

EMA Perspective
Tânia Teixeira, PharmD

Regulatory Perspective
Nikolai Constantin Brun

Patient Perspective
Jeff Allen, PhD

FDA Perspective
Jacqueline A. Corrigan-Curay



Speakers
avatar for Jeff Allen

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research, United States
Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As... Read More →
avatar for Nikolai Brun

Nikolai Brun

Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics, Danish Medicines Agency, Denmark
Background and experience in the clinical field and afterward in research and devel-opment of pharmaceuticals in the Biotech and Pharmaceutical Industry for 17 years with a long list of publications in high-impact journals. 4 years as Director of Division responsible for Medical Evaluation... Read More →
avatar for Jacqueline Corrigan-Curay

Jacqueline Corrigan-Curay

Principal Deputy Director, Office of the Center Director, CDER, FDA, United States
Jacqueline Corrigan-Curay, J.D., M.D., serves as Principal Deputy Center Director in the Center for Drug Evaluation and Research, FDA. Dr. Corrigan-Curay provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality... Read More →
avatar for Jeffrey Stuart

Jeffrey Stuart

Associate Vice President, Global Regulatory Affairs, Merck Sharp & Dohme LLC , United States
Jeff Stuart is a Regulatory Affairs Certified professional whose current interests include immunooncology and precision medicine. He has served as a speaker, session organizer, and steering committee member for several DIA events and has authored numerous scientific publications... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Official at the FDA, European Medicines Agency
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →


Monday June 25, 2018 11:00am - 12:15pm EDT
Room 205AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum