16th Workshop of the EURORDIS Round Table of Companies
“The value of partnering in RD therapies:
Benefits of working with patients along the treatment lifecycle in the areas of clinical trials, regulatory affairs and health technology assessment
1 March 2012, Brussels, Belgium
Venue:
Hotel Le Plaza Brussels
Boulevard Adolphe Max 118 -126
1000 City of Brussels, Belgium
Tel. + 32 2 278 01 00
Website: leplaza-brussels.be
Programme
Attendance to these workshops is limited to the ERTC Members, or on invitation.
For more information, please contact:
Maria Mavris
Therapeutic Development Director
maria.mavris@eurordis.org
Anne-Mary Bodin
Operations Unit Assistant
anne-mary.bodin@eurordis.org
15th Workshop of the EURORDIS Round Table of Companies
“Compassionate Access to Rare Disease Therapies”
Programme
Concept Paper
Conclusions
14th Workshop of the Eurordis Round Table of Companies
EURORDIS - ERNST & YOUNG
“Mechanisms for the Implementation of the Clinical Added-Value (Relative Effectiveness) of Orphan Drugs, CAVOD”
Fundació Doctor Robert- UAB Casa Convalescència Barcelona, Spain
Jointly organised by EURORDIS and ERNST & YOUNG, this workshop was the final meeting of ERNST & YOUNG's Feasibility Study on CAVOD in the framework of the European Commission Tender. A high number of participants gathered to discuss the preliminary results of the work performed by ERNST & YOUNG. Enormous progress was achieved towards shaping the future of the CAVOD mechanism and a consensus reached on common proposals for a feasible assessment mechanism. Participants: 82
Key feature: co-organised with Ernst & Young
Programme
Concept Paper
13th Workshop of the Eurordis Round Table of Companies:
"Patients' Access to OMPs, Innovative Pricing Schemes and National Measures in a Global Financial and Economic Crisis Environment"
13th December 2010
Les salons de l'Aéro-Club de France Paris, France
Attracting a larger audience than usual, the topic of this workshop was timely in a global financial and economic crisis environment, with additional pressure on national healthcare budgets. In a context of promotion of national plans and strategies on rare diseases in all the European Member States, the development of new and more appropriate measures to improve access to Orphan Medicinal Products has become a priority.During this workshop, the results of two surveys on patient access to orphan drugs were presented and the crucial need for an early dialogue and a coordinated EU approach were discussed, to aid patients’ access to Orphan Medicinal Products.
Participants: 86
Programme
Concept Paper
12th Workshop of the Eurordis Round Table of Companies:
“Retooling the EU Orphan Drug Regulation and US Orphan Drug Act for Better and Faster Development of Rare Disease Therapies”
June 18th, 2010
Fundació Doctor Robert- UAB Casa Convalescència Barcelona, Spain
A consensus was reached about using all the available tools offered by the current EU and US regulations, rather than starting a revision process for which the outcome would be rather uncertain. Several ways of improving the orphan drug regulations were evoked and solutions proposed to accelerate the development of orphan drugs on both sides of the Atlantic.
Participants: 61
Key feature: First time that a discussion bringing together all the stakeholders was taking place to reflect on the existing Orphan Drugs legislations both in the EU and US.
Programme
Concept Paper
11th Workshop of the Eurordis Round Table of Companies:
“Improving Access to Orphan Drugs for all Patients affected by Rare Diseases in Europe: EU Assessment of Clinical Added-Value of Orphan Drugs (CAVOD)”
December 11th, 2009
Les salons de l'Aéro-Club de France
Paris, France
Following the outcomes of the EU Pharmaceutical Forum in 2008,
the Commission Communication on Rare Diseases (November 2008) and the EU Council Recommendations on Rare Diseases (June 2009), this meeting provided the opportunity for all stakeholders to discuss the EURORDIS and the EBE(EFPIA)/ EuropaBio proposals on how to move towards the practical implementation of an effective and realistic procedure for the evaluation of the clinical added-value of newly authorized orphan medicinal products (CAVOD). During this meeting, an agreement was reached on the nature and specific objectives of the CAVOD report, as well as on the possibility of setting up a Working Party in charge of the CAVOD report at the European Medicines Agency level.Participants: 63
Key feature: first time that all the actors concerned by HTA in Europe were together to discuss a new innovative approach for Orphan Medicinal Products that could benefit all parties.
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