Personal Information
Organization / Workplace
Slough, United Kingdom United Kingdom
Occupation
EU+ Assoc. Medical Director at Biogen
Industry
Medical / Health Care / Pharmaceuticals
About
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...
Tags
phv
pharmacovigilance
qppv
pv
eu qppv
drug safety
See more
Presentations
(1)Likes
(2)Who is the EU QPPV and what do they do
Fiorenza Gaudenzi
•
8 years ago
Bioavailability and Bioequivalence Studies
Dr. Kunal Chitnis
•
10 years ago
Personal Information
Organization / Workplace
Slough, United Kingdom United Kingdom
Occupation
EU+ Assoc. Medical Director at Biogen
Industry
Medical / Health Care / Pharmaceuticals
About
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...
Tags
phv
pharmacovigilance
qppv
pv
eu qppv
drug safety
See more