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Hotel Grand Majestic Plaza

Jun 15, 2017 8:15 AM - Jun 16, 2017 5:00 PM

Truhlarska 16, 110 00 Prague 1, Czech Republic

DIA Workshop on Benefit-Risk Strategy

Session 4: Innovative Ways for Capturing and Presenting the Data

Session Chair(s)

Jan  Petracek, MD, MSc

Jan Petracek, MD, MSc

CEO, iVigee Services a.s., Czech Republic

This session will give you a good understanding how the regulators are expecting to see the data presented now and going forward. The session will also give hands-on tools to improve your benefit-risk data visualisation. The following will be discussed: - Visual methods & graphical presentation - IMI-PROTECT (IMI project developing new ways to present benefit-risk data)

Speaker(s)

Mick  Foy

Mick Foy

Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Innovative Ways for Capturing and Presenting the Data for Benefit-Risk Management

Kaatje  Bollaerts, PhD

Kaatje Bollaerts, PhD

Senior Statistician, P-95, Belgium

Monitoring the Expected Benefit-Risk Profile of a Vaccine Using an Interactive Dashboard

Jan  Petracek, MD, MSc

Jan Petracek, MD, MSc

CEO, iVigee Services a.s., Czech Republic

Case Study

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