Training

Training

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Capacity Building

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Relationship Management

Paolo Stocco
Paolo Stocco
Chief Executive Officer
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Alfredo Cesario
Alfredo Cesario
Chief Scientific Officer
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Barbara Cibin
Barbara Cibin
Chief Financial Officer
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Giorgio Roveggia
Giorgio Roveggia
Customer Relationship Manager
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Rome

Via Giuseppe Lazzati, 185

00166 - Roma

 +39 334 8643299

Veronella

Piazza Guglielmo Marconi 22

37040 - Verona

 +39 348 88 58 179

Brussels

Avenue Laterale, 65

1180 - Brussels

 +32 473977232

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Federsanità - Anci
Deloitte
Gii
EU-Open Consulting
is a Member of the Italian Initiative Group
of the Italian Embassy in Belgium, Bruxelles
bio-sci
Bio Sci Consulting
AdriaCongrex
AdriaCongrex
Metis
METIS
ADR Center
ADR Center
Unicatt
Sede di Roma
FAST
FAST
Federazione delle associazioni scientifiche e tecniche
Charles AUFFRAY
Charles Auffray
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Stefano Bonassi
Stefano Bonassi
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Willem Ivo (Pim) De Boer
Willem Ivo (Pim) De Boer
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Ingrid Klingmann
Ingrid Klingmann
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Graziano Onder
Graziano Onder
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Stefania Boccia
Stefania Boccia
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Nicola Marra de Scisciolo
Nicola Marra de Scisciolo
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Claire Ignaszewski
Claire Ignaszewski
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Innovative Medicine Initiative Project "SprintT -Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies"

May 2014

EU Open Consulting is co-leader with Sanofi RD of Workpackage 3 "Regulatory Consensus over operational definitions". The objectives of this work-package are:

Enabling regulatory tools for addressing the prevention of mobility disability in frail sarcopenic older persons, an unmet medical need in our aging EU population. More specifically:

  • Agree an operational definition of Physical Frailty & Sarcopenia - in order to assess the effectiveness of a multi-component treatment (centered on physical activity) in a randomized clinical trial.
  • Qualify a panel of biomarkers related to PF&S for future use in the same context;
  • Discuss with regulators novel methodologies for physical activity measurements and fall detection;
  • Refine the population definition based on the data generated by the RCT.

In order to realize these key objectives this WP will initiate and follow-up two Scientific Advice Procedures at the European Medicines Agency and put in place a Dialogue Platform with Stakeholders: Patients and Carers, General Practitioners and Health Care Professionals, Bioethics experts, ICT and Data experts.

The extended Dialogue Platform will include Regulatory Experts from the EU; non-EU Regulatory Authorities could be also invited as observers, bringing their region approach into the overall debate.

Early regulatory dialogue and the final outcome of the formal SA procedures embedded in the project will pave the way for future therapeutic development in the field of geriatric indications, an area of medical and societal unmet needs.

  www.mysprintt.eu