Pharmacovigilance

CRISTINA BIGINI

Pharmacovigilance

Via Meucci, n° 36 - 56121 Pisa - Loc. Ospedaletto
Telefono +39 050 3154101
Fax + 39 050 3154285
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Privacy Policy
PHARMACOVIGILANCE PRIVACY POLICY
In compliance with the EU Regulation 2016/679, Abiogen Pharma S.p.A., informs you that your personal data will be processed in a lawful, correct and transparent manner. For this reason, Abiogen Pharma S.p.A. wishes to submit to your kind attention the INFORMATION concerning the processing of personal data collected by the Company through this format. 
Information pursuant to art.13 E.U. Regulation 2016/679.
1)	Data Controller 
The Data Controller is Abiogen Pharma S.p.A., in the person of its legal representative Dr. Massimo Di Martino, with headquarters in Ospedaletto (PI), Via Antonio Meucci no. 36, whose contact details are: tel: +39 050.3154259; e-mail: segreteria.presidenza@abiogen.it  
2)	Data Protection Officer (DPO).
The Data Protection Officer (DPO) is lawyer Ms. Valeria Macchia, with offices in Livorno, Piazza Grande no. 38, whose contact details are e-mail: dpo@pec.abiogen.it
3)	Type of data processed
The processing concerns the following types of data:

-	common data: name, surname, telephone number and e-mail address.
-	special data (e.g. data relating to your state of health, medication intake, reports of adverse drug reactions).
 
4)	Purpose and legal basis of the processing
Your data will be processed exclusively for the purpose of fulfilling the regulatory requirements of Pharmacovigilance (e.g. identification of any adverse events following the taking of drugs, ascertaining the causal link between the administration of the drug and the adverse event, etc.)  
The legal basis for this purpose is Article 9.2, letter g, of the EU Regulation 2016/679, as well as Article 2 sexies, letter z, of Legislative Decree 196/03, as amended by Legislative Decree 101/18. 
In addition, personal data may be processed for legal purposes in accordance with Article 6.1, letter c, of the EU Regulation 2016/679 or to establish, exercise or defend a legal claim, pursuant to Article 9.2, letter f, of the EU Regulation 2016/679. 
5)	Compulsory or optional nature of providing data and consequences of a refusal to answer
The interested party is free to provide the personal data contained in the request forms to the Company. Failure to provide obligatory data marked with an asterisk will result in the impossibility of processing the data for the above-mentioned purposes.
6)	Possible recipients or categories of recipients of personal data 
The personal data of the data subject may be processed by employees of Abiogen Pharma S.p.A., which the Data Controller appoints as authorised processors, or by third parties which the Data Controller uses and appoints as data processors.
Furthermore, such data may be communicated to legitimate subjects in order to fulfil the obligations provided for by the law, regulations and Community legislation. 
7)	Transfer of data to a third country 
In the case of transfer of data to third countries that may not offer an adequate level of data protection, Abiogen Pharma S.p.A. guarantees that the processing will be carried out in accordance with the provisions of Chapter V of the EU Regulation 2016/679. 
8)	Period of retention of personal data and criteria used to determine that period 
Your personal data will be kept for the time necessary to fulfil legal obligations. The criterion used to determine the retention period is based on compliance with the rules set out in the EU Regulation 2016/679. Personal data will in any case be stored in pseudonymised form until the deadline indicated above, in order to prevent the identification of the subjects. After this period, your data will be destroyed.

9)	Data processing modes 
The data is processed by both automated and paper-based means, applying the security measures provided for in the regulations set out in the EU Regulation 2016/679. 

10)	Security Measures
 Abiogen Pharma S.p.A. uses technologies, security measures, rules and other procedures (e.g. minimisation and pseudonymisation) to protect your personal data from unauthorized access, improper use, disclosure, loss or destruction in accordance with the provisions of articles 25-32 of the European Regulation no. 679/2016. In order to guarantee data confidentiality, Abiogen Pharma S.p.A. uses firewalls and password protection systems that comply with industry standards.

11)	Rights of the persons concerned
Pursuant to Articles 15-22 of the E.U. Regulation 2016/679, the data subject shall have the right to request from the Controller access to, rectification or erasure of, or restriction of, personal data concerning him or her, or to object to their processing. The above requests should be addressed to the Privacy Group - GRUPPOPRIVACY@abiogen.it
12)	You may lodge a complaint with a supervisory authority or the Data Protection Authority.
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