Senior regulatory professional
Since November 2010
long acting insulin products tresiba® and ryzodeg® (degludec and degludecplus) clinical part of the registration file, phase 3a and 3b Clinical trials. close collaboration with eu, jpn, us and io. implementation of the new pharmacovigilence set-up (EMA) Long acting insulin products Tresiba® and Ryzodeg® (Degludec and DegludecPlus) Clinical part of the registration file, phase 3a and 3b clinical trials. Close collaboration with EU, JPN, US and IO. Implementation of the new pharmacovigilence set-up (EMA)
Regulatory proffesionalSeptember 2006 --- June 2007
Clinical file of the prandimet submission. international working group with nni princeton and nn china.
Group Leader & Specialist, International Product SafetyOctober 2000 --- September 2006
potential recalls, complaint and safety handling and coding. answers and reporting to authorities. legal cases. quarterly and surveillence reports. internal and external audits. team Leader. lean implementation in the administrative processes.
LinkedIn Assessment :
CBS (SIMI) in Medical Marketing Strategy (MMS) from Copenhagen Business School (SIMI) in 2010
Cand Pharm in cand pharm from Danmarks Farmaceutiske Universitet in 1991
High school certificate in Mathematics from Odense Katedral in 1984
P2I in from Power2Influence in 0000
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