ERTC Workshops
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.
Programme
Concept Paper
10th Workshop of the Eurordis Round Table of Companies:
“EURORDIS Strategy 2010-2015 and Partnership with the ERTC Members”
June 19th, 2009
Fundació Doctor Robert- UAB Casa Convalescència
Barcelona, Spain
To mark the 10th anniversary of the ERTC Workshops, this meeting focussed on the EURORDIS’ vision for the future, a vision shared by the US National Organisation for Rare Disorders (NORD) with whom a close collaboration is being implemented to coordinate efforts at a global level. This strategy will benefit the development of orphan drugs and will have a direct positive impact on the lives of patients living with a rare disease, in the two continents and beyond. This workshop was also the opportunity to take stock of five years of fruitful partnership with the pharmaceutical companies supporting EURORDIS via the ERTC.Participants: 50
Key feature: for the first time, participation from Peter Saltonstall, the newly appointed CEO of NORD, symbolised the start of an official collaboration between the two rare disease organisations. In the afternoon, the breakout sessions facilitated discussions on ways for industry of collaborating with EURORDIS on different specific actions.
Programme
9th Workshop of the Eurordis Round Table of Companies:
"Significant Benefit of Orphan Drugs:Impact on Clinical Development and Assessment"
December 12th, 2008
L’Aéro-club de France
Paris, France
Further to the revision of the EMEA Recommendation on significant benefit and the increasing discussions on added-value of orphan drugs at European level, this meeting provided a good forum to discuss how significant benefit can be linked to the post-marketing assessment of Orphan Medicinal Products in the Member States. Among the meeting outcomes, we can highlight the consensus on the need to communicate to the public on significant benefit. Greater transparency on the benefit provided by each new orphan drug authorised in Europe will certainly have an impact on the use of orphan drugs by physicians and patients, and, in general, on the recognition of the value of these products by national authorities and society at large.
Participants: 48
Key feature: Dr. Eric Abadie, Chair of the CHMP, EMEA, announced how the EMA will improve the visibility of such information in the future revised EPARs.
Programme
Concept Paper
8th Workshop of the Eurordis Round Table of Companies:
“Impact of the EU Paediatric Regulation on Orphan Drug Development”
June 20th, 2008Fundació Doctor Robert- UAB Casa Convalescència
Barcelona, Spain
One year after the adoption of the EU Paediatric Regulation, this workshop was an opportunity to learn how the regulatory professionals interpret and implement it in practice. In particular, how setting up a paediatric investigation plan links up with the various phases of orphan drug development (designation, protocol assistance, marketing authorisation). The afternoon discussion clarified the distinctive nature of the development of medicines for use in children and how to facilitate it.
Participants: 53
Key feature: first time that the orphan drug community analysed the benefits of the newly implemented paediatric regulation.
Programme
Concept Paper
7th Workshop of the Eurordis Round Table of Companies:
"Proof of Concept and Level of Evidence in Orphan Drug Development"
December 14th, 2007
La Maison des Arts & Métiers
Paris, France
Defining the term “Proof of Concept” is a difficulty in itself as it means confronting very different viewpoints. However, most participants of the 7th ERTC Workshop agreed that, in the case of orphan drugs, the demonstration of the proof of concept represents a green light to move forward to the next milestones. In the end, as underlined by one of the speakers, it may be more appropriate to talk about “proofs of concept”, rather than “proof of concept”, depending on the type of test done: from molecular, to mice, to man.Participants: 57
Key feature: an article from the French newspaper « Les Echos » reporting on our ERTC Workshop “Proof of Concept”.
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