Patient safety is of paramount importance to Gentium. It is our ethical and regulatory responsibility to monitor the safety of the medicines we develop from their preclinical stage, throughout clinical testing and for as long as they are prescribed to patients. Timely reporting to Drug Safety is critical to enable compliance with regulatory requirements.
Healthcare professionals are asked to report any suspected adverse reactions via their national reporting system listed in the correspondent SPC. Adverse events should also be reported to Gentium using one of the language-specific telephone numbers listed below.
Please note that if you are a patient reporting occurrences of adverse events or if you have questions about your condition, please contact your health care practitioner. Medical Safety and Medical Information personnel do not provide answers or advice about individual medical questions.
COLLECTION OF PERSONAL DATA – INFORMATION (article 13 D. lgs. 196/2003)
1. In compliance with the provisions of the article 13 D. Lgs 196/2003 (the “Privacy Code”), Gentium S.r.l. informs about the purpose of the collection and the use of personal information, communication and diffusion and the nature of the requested information.
2. Information collected by Gentium S.r.l. are processed and used for instrumental purposes connected to the reporting of adverse reaction, in a fair way and respecting the law and privacy of natural persons.
3. Personal data are processed through paper and electronics means. Data are stored in paper or electronics archives in full respect of minimum security measures required by law.
4. Personal information won't be shared, sold or exchanged with third parties, unless communication to third parties is functional to meet the above mentioned purposes and unless it is essential to carry out the obligations undertaken by the parties. In this case the treatment of personal information shall be fair and in respect of law. Gentium S.r.l. reserves the right to disclose personal information to third parties where required by law, regulatory, law enforcement or other government authority of a competent jurisdiction in order to protect our rights and/or to comply with such legal proceedings. Such disclosure shall occur on a ‘need-to-know’ basis, unless otherwise instructed by a regulatory or other government authority. Personal Information is safely stored on secure servers that only authorized personnel have access to via password. Data will be held for only for the time strictly necessary to carry out the activities mentioned in the previous article 2.
5. You have the right to obtain confirmation of the existence or non-existence of the personal data concerning the same, even if not yet recorded, and the communication of the said information in an intelligible form. You shall have the right to obtain the following: a) the source of the personal data; b) the purpose and the means of processing; c) the logic applied if the data is processed using electronic means; d) the personal information concerning the proprietor, the officers in charge and the representatives nominated in accordance with Article 5, subparagraph 2 of the Privacy Code; e) the subjects or categories of subjects to whom the personal data might be communicated or who might acquire knowledge of the same in his/her position of representative nominated for the territory of the State, of officer(s) in charge or of designated person(s). You shall have the right to obtain: a) the update, the correction, or the integration of the data, if of interest to the same; b) the cancellation, the transformation into an anonymous form or the blocking of the data which have been processed unlawfully in addition to the data which do not need to be preserved in relation to the purposes for which the said data have been collected and subsequently processed. c) the certification that the operations pursuant to letter a) and b) have been made known, also with regards to their content, to those to whom the data have been communicated or published, with the exception of those cases in which the said fulfillment becomes either impossible or requires the employment of means which are manifestly disproportionate to the rights protected.
6. Gentium S.r.l., located in Villa Guardia (CO) Piazza XX Settembre 2, P.IVA/CF 02098100130 shall be considered as the owner of the personal data processed.