Fiorenza Gaudenzi

Slough, United Kingdom United Kingdom

EU+ Assoc. Medical Director at Biogen

Medical / Health Care / Pharmaceuticals

As EU+ Assoc. Medical Director: Responsible and signatory for labelling activities in EU+ geographies, and responsible for safety content of responses to product regulatory queries originating from EU+ geographies; Responsible for the generation of the core and EU RMP for new product/indication filings with support of Epi and Medical Writing; responsible for post-approval maintenance of core RMP and EU RMP for assigned products; Responsible for overseeing and a signatory of Post-authorization safety studies (PASS) and other assigned studies in EU+ geographies; accountable for input on protocol design, ICF Safety content, study life-cycle activities including participation in interim and e...