“RWD TRENDS IN PHARMACOEPIDEMIOLOGY AND OPPORTUNITIES FOR RWE”

Chairs:

Brigitte Franke-Bray, (MD PhD) FFPM GFMD, Specialist in Pharmaceutical Medicine FMH, Treasurer IFAPP

Elena Panitti, MD, Global Head RWE Excellence Novartis, Basel, Switzerland

Speakers:

‘Quality in RWD Initiative in Austria’

Johannes Pleiner-Duxneuner, Priv. Doz. Dr, President GPMed

‘MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions’

David Brown, Statistician, Medicines and Healthcare products Regulatory Agency (MHRA), MHRA-Licensing

‘A vision for use of real-world evidence in EU medicines regulation: the DARWIN EU network’

Juan Jose Abellan, Data Analytics and Methods Task Force, Scientific Lead for DARWIN EU, EMA

Speakers

Franke-Bray Brigitte

MD, PhD, FFPM, GFMD, Treasurer and Board Member of IFAPP, Member of Board and Executive Committee of PharmaTrain, Advisory Board Member of ECPM, Consultant in Pharmaceutical Medicine

«Chair»

Panitti Elena

MD, Global Head RWE Excellence, Novartis Pharma AG, Basel, Switzerland

«Chair»

Brown David

Statistician, Medicines and Healthcare products Regulatory Agency (MHRA), MHRA-Licensing

«Speaker»

Abellan Juan Jose

Data Analytics and Methods Task Force, Scientific Lead for DARWIN EU, EMA

«Speaker»