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Tuesday, June 20 • 4:00pm - 5:15pm
#288: Breaking Down the Wall for Global Regulators to Leverage Real World Data

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will present global perspectives on the use of real world evidence for drug and device regulatory decision making including postmarket surveillance, fast track or acceleration programs, conditional approval programs.

Learning Objectives

Describe a global view of access and use of data.


Duane Schulthess, MBA


Lessons Learned From the EMA Adaptive Pathways Pilot Project: The Need for a Real-World Data Strategy for Success
Radek Wasiak, PhD, MA

When and How Can Health Care Database Analyses Replace RCTs in Marketed Medications?
Sebastian Schneeweiss, DrSc, MD

Alison Cave, PhD

Nicola Bedlington

avatar for Duane Schulthess

Duane Schulthess

Managing Director, Vital Transformation
Duane is the Managing Director of Vital Transformation which consults to national health authorities, blue chip multi-national organisations, governments, and stakeholder groups on healthcare policy and technology. He and his firm have developed many unique techniques and methods... Read More →

avatar for Nicola Bedlington

Nicola Bedlington

Secretary General, European Patient's Forum
Nicola Bedlington was first Executive Director of the European Patients’ Forum (EUPATI), which she continues to serve as its Secretary General, and is co-founder of Patients Access Partnership (PACT). She previously provided leadership to the Swiss government’s Environment and... Read More →
avatar for Alison Cave

Alison Cave

Principal Scientific Administrator, European Medicines Agency (EMA)
Alison Cave is a Principal Scientific Administrator at the European Medicines Agency within the Pharmacovigilance and Epidemiology Department. She has over 20 years of academic research experience in the cardiovascular field gained in the US and UK. Prior to joining the EMA she was... Read More →
avatar for Sebastian Schneeweiss

Sebastian Schneeweiss

Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology, Harvard Medical School and Brigham and Women's Hospital, United States
Dr. Schneeweiss's research focuses on assessing the effectiveness and safety of biopharmaceuticals in clinical practice. He has developed analytic methods to improve the accuracy of estimating causal treatment effects of new drugs using complex digital healthcare databases. His work... Read More →
avatar for Radek Wasiak

Radek Wasiak

Vice President and General Manager, Real-World Evidence and Meta Research, Evidera
Radek Wasiak has experience in health economics and services, and multidisciplinary research, including analyses of burden of illness or effectiveness of healthcare interventions in oncology, pain, infectious diseases, women’s health. As a research scientist at the Liberty Mutual... Read More →

Tuesday June 20, 2017 4:00pm - 5:15pm CDT
N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  10: Value-Access, Forum