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The quality system

ASSURING IBI PRODUCT QUALITY

The Quality System follows and adds onto the national (AIFA) and international (EU GMP and 21 CFR 210-211 for US FDA) standards on protecting patients’ health. The Quality System strives for ongoing improvement and takes care of the whole lifecycle of IBI products, to guarantee their constant quality.

THE QUALITY CONTROL LABS

IBI’s modern Quality Control labs are authorized by the pharmaceutical authorities (AIFA- USFDA). Here IBI performs all the analyses needed to control the quality of medicines and APIs for human and experimental use (GMP). Constantly up-to-date on the developments in the field, IBI’s highly professional and qualified specialist technicians apply IBI's Quality Management System procedures to follow the production activities and check that the products correspond to specifications.

QUALITY ASSURANCE

IBI's Quality Assurance guarantees that GMP (Good Manufacturing Practices) principles and standards are always applied and constantly implemented when defining and supervising quality levels.
Its plants and the Quality System are regularly checked and certified by national and international supervisory bodies, such as FDA, EMA, ISS and AIFA Certiquality.

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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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