Over the past years, assessment of drug safety has been radically reshaped by the availability of safety databases, which are the global repository of thousands of data, and a critical element of pharmacovigilance work. As a key tool for the evaluation of safety data, it is necessary that safety databases undergo periodic evaluations to guarantee their correct operation, ensuring compliance with the Pharmacovigilance relevant regulatory requirements and data security.
Miriam Alvarez, Drug Safety Manager at Asphalion, reviews the essential elements to take into consideration, including QMS, management of computerized systems, access control; data protection, etc. Furthermore, she goes over the relevant documentation to keep in mind, and will offer tips on which are the most common findings in this type of audits.
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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