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Swissôtel Le Plaza

Oct 24, 2019 9:00 AM - Oct 25, 2019 5:30 PM

Messeplatz 25, 4005 Basel, Switzerland

Future of Evidence Workshop

RWE and RCT as building blocks for transformative evidence generation

Session 1: Setting the Stage, Global Regulatory Experience (and Data Quality Standards)

Session Chair(s)

Inger  Mollerup, MS, MSc

Inger Mollerup, MS, MSc


Inger Mollerup Regulatory Consulting, Denmark

Sources for Real World Data supporting RWE are multiple and include electronic medical records, medical charts, claims data, product and disease registries, and patient generated data/patient reported outcomes. In the regulatory environment, safety databases (e.g. FDA’s Sentinel System and PMDA’s MID-NET) are used to follow drug safety in the post marketing space, and examples of other regulatory use of RWD such as the supportive RWE to provide data on historical response rates drawn from chart are appearing. In this session we will hear about the approach for utilising RWE for regulatory purposes from the 3 major regions, EU, US and Japan, what requirements they have to ensure that the quality of the data can support regulatory decisions, and what their expectations are for future use of RWE.


Peter  Mol, PharmD, PhD

Use of Real World Data for Regulatory Purposes Pre- and Post-Approval, European Perspective and Experience

Peter Mol, PharmD, PhD

MEB, Netherlands

CHMP member, NL

Yoshiaki  Uyama, PhD, RPh

Utilising Real World Data: PMDA’s Perspective and Experience Based on Japanese Databases (REMOTE via Zoom)

Yoshiaki Uyama, PhD, RPh

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Associate Executive Director

M. Khair  ElZarrad, PhD, MPH

Incorporating Real World Evidence into Regulatory Decision Making: FDA Perspective, Guidance and Experience

M. Khair ElZarrad, PhD, MPH

FDA, United States

Director, Office of Medical Policy, CDER

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