Daniela Serinoli

Background

About Daniela Serinoli

I am a pharmacist with practical experience in regulatory affairs, analytical development, validation; Responsible for evaluation of post-approval change requests defining the actions/documents needed for compliance with local Brazilian regulation; Evaluation of technical/regulatory documents in order to have the post-approval, immediate implementing variation and annual report sent to Brazilian local HA and compliance with local regulation; Knowledge in brazilian regulation and their practical impact in the drug product/drug substances related to the subjects on stability (including forced degradation studies evaluation), analytical validation/transfer of analytical method, method verification (compendial/pharmacopeial), analytical development, GMP requirements and post approval variation as well as international guidelines on the same subjects (ICH, EMA and FDA); Responsible for evaluating Quality Risk assessments and change control. Knowledge in CTD format dossiers. Knowledge in Veeva Systems. Dual nationality: brazilian and italian (EU citizenship).