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NEWS
07/07/2014: When bureaucracy calls for transparency:::: Rosario Imperiali: Holdership of the (Physicians) archives furnished by third parties:::: 06/05/2014 Data Certification Self-Diagnosis opportunity for companies :::: 04/22/2014 The Pharmasoft FEA CTA approved the issuance of the Certificate of Compliance SGCMF © 10002:2013 for the Pharm@idea Company :::: Appreciation from the Presidenty of the Italian Republic for Pharmasoft FEA :::: MSD Italy: issued the certificate of conformity SGCMF 10002 © covered by ACCREDIA – Italian Accreditation System:::: Bayer among the first companies to certify its "Data protection":::: 26 June 2013 BRISTOL MYERS SQUIBB Obtained the Certification Mark SGCMF:::: MSD Italy obtained the Certification Mark SGCMF::::19 March 2013:DOMPE'Italy already did their “homework”. Pending the new EU Regulation regarding the management of personal data the pharmaceutical company obtains the Certification Mark and prepares for the appointment with the new Privacy::::20 february 2013: Pharmasoft-fea announces the release of the first Marks 2013 for the certification of the physician archives for the multinationals ALMIRALL and ASTRAZENECA::::

pharmasoft fea

Pharmasoft FEA is a Certification Body independently accredited by the ACCREDIA (Italian National Accreditation Body). It is the first European Certification Body that operates exclusively in the specific areas of accreditation IAF 13 (pharmaceutical products) and IAF 38 (healthcare providers and other health care services). Pharmasoft works with Pharmaceutical and Healthcare companies guaranteeing specificity and in-depth knowledge of all of the elements that characterize an area as sensitive and specific as health. Our distinctiveness is to interpret the need for certainty and reliability, even through the use of new and modern types – specific certification schemes.

PHARMASOFT FEA IS:

CERTIFICATION

PHYSICIANS ARCHIVE
SGCMF©10002:2013

Certificazione archivi medici SGCMF10002:13

 FARMINDUSTRIA
CODE OF ETHIC

Certificazione codice deontologico Farmindustria

QUALITY MANAGEMENT
ISO:9001

Certificazione sistemi di gestione per la qualità ISO:9001
 

ISO:27001

Certificazione ISO:27001

PRIVACY SPERIMENTATION CLINICAL TRIALS

Certificazione privacy sperimentazioni cliniche

DATA PROTECTION
ISO/IEC 17020

Certificazione data protection iso/iec 17020
 

VERIFICATION INSPECTION OF DATA PROTECTION ISO/IEC 17020

Verifiche ispettive data protection iso/iec 17020

TRAINING

Training

AUDIT

Audit
 
 

PHARMA NEWS

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WHEN BUREAUCRACY CALLS FOR TRANSPARENCY

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WHEN BUREAUCRACY CALLS FOR TRANSPARENCY

In the last annual report of Transparency International (ONG specialized in evaluating the corruption coefficient of world countries) Italy was ranked 69 on a scale of 177 countries. Does the excessive bureaucracy of the processes give it a hand? The term, defined systematically by Max Weber (Economist, Sociologist, historical German 1864 – 1920) indicates: The “power of office”.We must also say ...

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DATA CERTIFICATION SELF-DIAGNOSIS OPPORTUNITY FOR COMPANIES

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DATA CERTIFICATION SELF-DIAGNOSIS OPPORTUNITY FOR COMPANIES

(Pharmakronos)Data protection, problems for the managers? In Italy, it seems so. To confirm this is Riccardo Giannetti, president of Pharmasof fea, on the sidelines of the workshop “Study on the European Union Privacy Seals” organized last April, in Brussels by the European Commission Directorate – General for Justice (Dgjust). Pharmasoft together with Accredia (the Italian National Accreditation ...

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IMPARTIALITY

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IMPARTIALITY

It is necessary that a certification company be impartial and it must also be perceived as such. This condition must be strictly met to convey confidence when issuing a certificate that transmits security. It is well know that a company’s source of income is its client, who pay for certification and this is a potential risk to impartiality. It is therefore essential, in order to obtain and maint...

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Holder as the center of obligations and responsibilities of the laws

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Holder as the center of obligations and responsibilities of the laws

The data holder is the person or institution who independently decides about the aims and methods of management and therefore determines the contents of the information. When the holder is a legal person, he/she may delegate the holdership to individuals with appropriate powers when needed.

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DDL simplifications: The Italian Data Protection Authority’s concerns

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DDL simplifications: The Italian Data Protection Authority’s concerns

The Italian Authority for the protection of personal data expressed extreme concern regarding the simplification of the DDL (Data Definition Language) that was approved by the government today on the standards of privacy. To be excluded from the application of the Code of personal data is anyone acting in an entrepreneurial activity, even individual, as it deprives the entrepreneurial rather th...

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New standards for internet and telecommunication data security

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New standards for internet and telecommunication data security

Telephone companies and internet providers have the obligation to inform users in the case of personal data distribution or loss. Telephone companies and internet providers must ensure the maximum protection of personal data because part of their new obligations will be to inform users in serious cases regarding the violation of their database that could involve the loss, destruction or misappr...

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POINT OF VIEW...

  • Rosario Imperiali: Holdership of the (Physicians) archives furnished by third parties

    Rosario Imperiali: Holdership of the (Physicians) archives furnished by third parties

  • Gianluca Di Ascenzo – Protection of privacy and the right to delete (art. 17)

    Gianluca Di Ascenzo – Protection of privacy and the right to delete (art. 17)

  • Maria Roberta Perugini – Data Profiling (art. 20)

    Maria Roberta Perugini – Data Profiling (art. 20)

  • Luciano Ferrarini, Sales Director of Pierre Fabre Pharma

    Luciano Ferrarini, Sales Director of Pierre Fabre Pharma