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Session 2: What Does EU HTA Mean for Global Clinical Development Plans and Evidence Generation?
Session Chair(s)
Claudine Sapède, PharmD
Director, Global HTA Policy, NOVARTIS INTERNATIONAL, Switzerland
Matias Olsen, MA
Senior Manager, Public Affairs & Policy , European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium
Joint scientific consultation (JSC) provides an opportunity for companies to develop plans for the generation of evidence that can meet the needs of both regulatory agency and HTA bodies and facilitate the preparation of joint clinical assessments. Yet, proposing an asset for JSC presents both opportunities & challenges. In this session, we will discuss how cross-functional collaboration across access, regulatory, clinical development and other functions can help optimizing clinical development plans and evidence generation in the context of EU HTA.
Speaker(s)
Martin Scott
Scientific Director, Numerus GmbH, Germany
Scene Setting