Lene Hansen Email & Phone Number

Søborg, Region Zealand, Denmark

Denmark

Since 2014 annually representing the Danish Medicines Agency giving lecture at following course:"Regulatorisk Life Cycle Management", topic: Quality variations to marketing authorisationPreviously also given lecture in course:- "Holdbarhedsdokumentation", topic: Stability data and CTD module 3

Copenhagen, Capital Region, Denmark

Centre for Medicines Licensing and Pharmacovigilance | Quality Assessment and Clinical Trials Department | Pharmaceutical Quality UnitCore task in the Pharmaceutical Quality Unit:Assessment of the entire CMC | quality documentation (module 3, Part II, IMPD) in all stages of life cycle (clinical trials, marketing authorisation, variations, out of specification situations) and in the different EU approval procedures. Knowing the overlap to GMP. Primary field: Small chemical molecules | APIs, including peptides.Knowhow and responsibilities:- Different strategic, cross-disciplinary or project teamwork in-house or with EU Authorities. - Responsible for liaison with industry, internal experts and EU Authorities.- Knowing the EU pharmaceutical legislation, CMC requirements, guidelines and pharmacopoeias.- Responsible for guidance to industry on legislation and guidelines and scientific advice meetings.- Expert on the EU variation systems with focus on CMC changes (human and veterinary).- Responsible for maintaining and updating quality management system and local SOPs/materials.- Responsible for in-house and international meetings, training and workshops - ready to travel.Appointed CMC | quality expert for Denmark in other EU Authority Institutions:- For EMA (the Netherlands) in the centralised procedure for approval of medicine.- For EDQM (France) in the certification procedure for approval of certificates of suitability ("CEP").- For EDQM (France) as member of technical advisory board ("TAB").

Copenhagen, Capital Region, Denmark

Knowhow and responsibilties:See under "Senior adviser". Less focus on conducting core task of the Pharmaceutical Quality Unit and more focus on strategic, cross-disciplinary and project teamwork.

Copenhagen, Capital Region, Denmark

Knowhow and responsibilties:See under "Senior adviser", but with main focus on conducting core task of the Pharmaceutical Quality Unit. Primary field for a limited period also expended to APIs of biological origin.

Copenhagen, Capital Region, Denmark

Kongens Lyngby, Capital Region, Denmark

Pharmacist | Master Of Science In Pharmacy | Cand. Pharm.

Master thesis conducted in collaboration with Section of Forensic Chemistry, Department of Forensic Medicine, University of Copenhagen..

Upper Secondary Education | High School | Mathematics