title: [Type Code of the pharmaceutical industry for the protection of personal data in the field of clinical research and pharmaceutical surveillance].
abstract: The Type Code establishes uniform criteria in the sectoral application of the Organic Law on Data Protection (LOPD) and its implementing Regulation increases the guarantee of its compliance and reduces the level of uncertainty as to its implementation. Two key activities in the pharmaceutical industry are considered, namely clinical research and pharmacovigilance, all scenarios that take place in the daily practice of these activities are developed and procedures for the use of personal data and irreversible dissociation are established, with these last being exempt from the application of data protection legislation. It develops a protocol that includes the guidelines to follow with regard to the exercise of rights of access, rectification, cancellation and opposition exercised by those affected and stipulates the supervisory functions of the Code by the Monitoring Committee.
authors.affiliation: Departamento Jurídico de Farmaindustria, Madrid, España.
authors.forename: Lourdes
authors.initials: L
authors.lastname: Fraguas
authors.forename: Mercedes
authors.initials: M
authors.lastname: Francés
authors.forename: Patricia
authors.initials: P
authors.lastname: Riesgo
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D016494:Computer Security / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing; D013030:Spain