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Participant's comments

  • The questionnaire is a good way to identify how well the registers are working.

  • Our registry is in a kind of ethical/legal limbo...

  • Good initiative. I wish you best results in your research.

  • The main role of the EU should be to make European registry easy: harmonizing laws, providing technical solutions accepted by all EU authorities.

  • Thank you... it was nice!

  • The initiatives by the EU in relation to rare disease registries is a catalyst internationally ; it has resulted in a registry formation in Australia and New Zealand. National NMD registries and other rare disease registries are in existence because of the pioneering work in the EU

  • We have recently been approached by two pharmaceutical companies to collaborate on studies about long-term monitoring post marketing. It seems that the EMA has asked them to rely on the registries. On one side participation may be of interest to the registers, and all means to alleviate the workload of data providers, who are also in charge of the patients (and many other tasks) should be attempted . It is also highly desirable do harmonize the kind of data required for such post marketing surveillance. On the other side, most of the Registries do not have the data that have been asked: too precise, too often (quartely data required whereas register records annual information), patient recorded "outcome"... Collaboration with EMA and industry may be interesting if some additional funding is available for data provider to enter the data, but should be harmonized, because it is not difficult to add variable continuously and for any new medicinal product that will be marketed.

  • We have some concerns regarding the use of disease registries for postmarketing surveillance, as it apparently now being recommended (required?) by the EMA) the variables requested are many - for each drug - and will require addition of variables in the existing registries. Some may have to change the whole setup of their database because they only allow once-a-year entry of data, not several times a year. Who will pay for this?

  • Our register was too poor of information to be valuable information and therefore was eliminated. We have realized that to make real statistical data must be collected from a number of different people and not only researched and compiled by those who have the RD

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