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Swissôtel Le Plaza

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

Messeplatz 25, 4005 Basel, Switzerland

Value, Access & Regulatory Evidence Workshop

Acknowledging the different perspectives and finding the pragmatic way forward

Session 6: Joint Clinical Assessment (REA)

Session Chair(s)

Claudine  Sapède, PharmD

Claudine Sapède, PharmD

Director, Global HTA Policy

NOVARTIS INTERNATIONAL, Switzerland

In this session panellists will discuss the state of play, experience from REA pilots and potential development post 2020 surrounding joint clinical assessments (JCAs) - a key component of the joint work across European HTA agencies. What good quality means for stakeholders in relation to clinical HTA methodological standards for JCAs? What practical as well as policy implications this may have for stakeholders and sustainability of EU cooperation? During the workshop session the audience will also be invited to share its perspective and experience.

Speaker(s)

Anja  Schiel, PhD

Panel Discussion

Anja Schiel, PhD

Norwegian Medicines Agency (NoMA), Norway

Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA

Edith  Frénoy, MA, MSc

Panel Discussion

Edith Frénoy, MA, MSc

MSD Europe Inc., Belgium

Director, European Public Policy – Strategic EU Advocacy Lead

Michael  Berntgen, PhD

Panel Discussion

Michael Berntgen, PhD

European Medicines Agency, Netherlands

Head of Scientific Evidence Generation

Anne  Willemsen, MSc

Panel Discussion

Anne Willemsen, MSc

ZIN - National Health Care Institute, Netherlands

Senior Project Manager, Joint Production Co-Lead Partner - Pharmaceuticals

Kalitsa  Filioussi

Kalitsa Filioussi

ORE, Novartis Oncology, Italy

European Market Access Director, Hematology

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