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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

Anja Schiel, PHD

Special Advisor, Lead Methodologist/Statistician; NOMA, Norwegian Medical Products Agency (NOMA), Norway

Panel Discussion

Edith  Frénoy, MA, MSC

Edith Frénoy, MA, MSC

Director, European Public Policy – Strategic EU Advocacy Lead, MSD Europe Inc., Belgium

Panel Discussion

Michael  Berntgen, PHD

Michael Berntgen, PHD

Head of Scientific Evidence Generation, European Medicines Agency, Netherlands

Panel Discussion

Anne  Willemsen, MSC

Anne Willemsen, MSC

Senior Project Manager, Joint Production Co-Lead Partner - Pharmaceuticals, ZIN - National Health Care Institute, Netherlands

Panel Discussion

Kalitsa  Filioussi

Kalitsa Filioussi

European Market Access Director, Hematology, ORE, Novartis Oncology, Italy

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