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Pharmacovigilance

Reporting side effects

The Company’s Pharmacovigilance system has the aim to collect all the safety information and to improve the use    of the active principles/ medicinal products of which detain the Marketing Authorization Holder (MAH) and, when possible, to reduce the risk of side effects of their products.
In order to guarantee the safety of the patients, the Pharmacovigilance Unit collects, assesses and analyses spontaneous reports of adverse reactions and provides this information to the competent authorities.
Furthermore, the Pharmacovigilance Unit ensures that all the information related to drug safety is immediately send to the attention of healthcare professional.

From July 21st, 2012 healthcare professional and/or citizens can spontaneously report suspect adverse reactions directly to AIFA (Agenzia Italiana del Farmaco – national competent authority in Italy) through dedicated paper or electronic form.
The instruction on how to get and send a report is reported in the following link.
In case of reports regarding herbal medicnal product and food supplements please refer to the following link.

For reporting any adverse drug reactions in patient following the use of IBI or IBIGEN medicinal products, or for requesting information on the safety of IBI or IBIGEN medicinal products, you can directly contact the company by filling the following form.

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INFORMATION PURSUANT TO ARTICLE 13 OF REGULATION EU NO. 2016/679

Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. (hereafter IBI) situated in Via Fossignano n°2 – Aprilia (LT), pursuant to article 13 of Regulation EU no. 2016/679 (hereafter Regulation) as Data Controller would like to inform you of the following.

The personal data supplied in connection with Pharmacovigilance activities which IBI is legally bound to perform (D.M. April 30th, 2015), will be collected and processed in paper and electronically exclusively for the proper implementation of activities connected to Pharmacovigilance purposes such as, for example: (i) identifying any unknown adverse reactions; (ii) improving and strengthening information of any known suspected adverse reactions; (iii) assessing the casual link between the dosage and the adverse reaction observed; (iv) communication of such information to ensure that the drugs used have a favourable risk/benefit ratio for the population. It is necessary to provide these details and in case of failure, we would not be able to perform the activities mentioned above.

The retention of personal data and documents relating to individual authorised medicinal products will be stored as long as the marketing authorisation exists and for at least further 10 years after the marketing authorisation has ceased to exist.

The Pharmacovigilance Unit can come to know your personal data only for the mentioned purposes. Data can be supplied to Regulatory Authorities if required, in connection with harmacovigilance activities, in accordance with applicable legislation and to individuals who are authorised to access the data by law and/or by secondary legislation. Outside of these situations, data will not be communicated and diffused to any third party.

Data will not be send outside the European Union.

We wish to inform you that, pursuant to article 15 of the Regulation, you have the right to require to the controller the access, rectification and deletion of the personal data or the restriction of the regulation that will affect them or to object to the processing.

These rights may be exercised writing to the email address info@ibi-lorenzini.com.

The subject, with regards to the processing of their personal data, has the right to complain directly to the supervisory Authority. The Data Protection Officer can be contacted to the following email address: dpo_ibi@protectiontrade.it

 Consent to the personal data processing

Obtained the information provided for art.13 of Regulation, I give the consent to processing the personal data exclusively for Pharmacovigilance activities.

Dichiarazione in merito al GDPR (Regolamento Generale Protezione dei Dati)

In caso di sottoscrizione Newsletter dovrai confermare l’iscrizione per mezzo di mail di conferma inviata all’indirizzo inserito. In tal caso il trattamento prevede:

la profilazione dell’utente in gruppi, status, preferenze secondo quanto indicato e dedotto dalle informazioni inviate tramite il form o successiva autonoma profilazione.
l’utilizzo del dato per l’invio di comunicazione a mezzo digitale (email, whatsapp) e non (cartaceo) avente scopo informativo/commerciale.
l'utilizzo della mail per la generazione di campagne marketing e informative personalizzate, digitali e non.

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Dichiarazione in merito al GDPR (Regolamento Generale Protezione dei Dati)

In caso di sottoscrizione Newsletter dovrai confermare l’iscrizione per mezzo di mail di conferma inviata all’indirizzo inserito. In tal caso il trattamento prevede:

la profilazione dell’utente in gruppi, status, preferenze secondo quanto indicato e dedotto dalle informazioni inviate tramite il form o successiva autonoma profilazione.
l’utilizzo del dato per l’invio di comunicazione a mezzo digitale (email, whatsapp) e non (cartaceo) avente scopo informativo/commerciale.
l'utilizzo della mail per la generazione di campagne marketing e informative personalizzate, digitali e non.

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Notice on the treatment of personal data

Dear visitor, in the following sections we will describe how the reserved area of the www.ibi-lorenzini.it website is managed as far as processing personal data of users. The notice is issued pursuant to art. 13 of EU Regulation 679/2016 (hereinafter also the Regulation) on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and applies to those who interact with the website of Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. (hereinafter I.B.I.), which can be accessed at the following address: www.ibi-lorenzini.it, the opening page of the official I.B.I. website. The notice only applies to the I.B.I. website. It does not apply to any other websites that the user may access through links.

  1. The processing of the personal data that you supply, which are also used for the creation of your user profile, and which will be included in the “Doctors’ Details” database, has the following purposes:
  • carry out medical sales related activities for drugs for human consumption. Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. and Ibigen S.r.l., part of the same company group (hereinafter also Ibigen Group), carry out such activities in compliance with the provisions of the current regulations, with particular, but not exclusive, attention to Italian Legislative Decree no. 219 of 24.04.2006 and subsequent modifications. In view of the objectives of the Ibigen Group, it is important to point out that the processing activities do not deal with any special data. The supply of the data for the medical sales activities is necessary, and failure to provide consent will make it impossible for us to fulfil the above objectives;

  • forwarding of invitations or information on congresses, conferences, seminars, communications on initiatives promoted or sponsored by the Ibigen group, regular or occasional publications, information on new products, methods and services. Such activities are carried out by e-mail, fax, SMS, normal post or telephone. The supply of the data for such purposes is optional, and failure to supply them will result in the information not being forwarded.

  1. As far as the creation of your profile on our website, we remind you that your password is strictly confidential and should not be disclosed.
  2. Your data will not be disclosed, but may be shared with individuals, companies, associations or professional studios providing support or consultancy services to the Ibigen Group, the medical sales representative network, our suppliers and any sub-suppliers - from time to time entrusted with activities connected with the above objectives -, mailing or statistical survey companies, or companies for the forwarding of scientific documentation, and individuals authorised to access the data by law and/or pursuant to secondary regulations.
  3. Such people may only acquire knowledge of your personal data for the above mentioned purposes.
  4. The Owners of the Treatment (Data Controllers) are the two companies of the Ibigen Group with legal headquarters at Via Fossignano no. 2, Aprilia (LT), Italy.
  5. Personal data are processed using manual and automated means, for the time necessary for reaching the objectives for which they were collected. Special safety measures are in place to avoid data loss, unlawful or incorrect use and unauthorised access.
  6. Lastly, we also inform you that you can at any time exercise the rights contemplated by the Regulation, and in particular request access to the data, their correction, update and block, or you can withdraw your consent, or request the limitation of the processing or the cancellation of the data. As data subject, you also have the right to issue a complaint with the relevant control Authority. Such rights may be exercised in writing to the following e-mail address: info@ibi-lorenzini.com.
  7. The Data Protection Officer may be contacted at the following e-mail address: dpo_ibi@protectiontrade.it

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