Søren Aggeboe

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Profile

Søren Aggeboe
Regulatory Business Manager at H. Lundbeck A/S
Pharmaceuticals | Copenhagen Area, Denmark, DK

Summary

Electronic Submission in eCTD format:
- EU (National, MRP, DCP and Central) DTD 1.4
- CA DTD 1.0
- Certificates of Suitability (CEP) for EDQM

EVMPD/IDMP:
- EVWEB trained

Regulatory projects/applications:
- S-Cubed 4.3 and 4.5.2 (Datafarm/Liquent)
- eCTD validation tools
- Adobe Acrobat Plug-ins for electronic submission
- EudraVigilance Medicinal Product Dictionary (EVMPD) trained
- HP Quality Center 9.2

Knowledge of:
Regulatory Compliance
Specialties: - Electronic Submission in eCTD format - System validation - Upgrading projects

Experience

  • Nov 2010 - Present
    Regulatory Business Manager / H. Lundbeck A/S
    Responsible for the operation, maintenance and development of the eCTD publishing tools
  • Mar 2005 - Present
    Student Assistant / H. Lundbeck
    Global Registration & Submission Tracking. Regulatory projects/applications: - Register™ client 3.x and web app 5.1 (ArisGlobal) - EudraVigilance Medicinal Product Dictionary (EVMPD) trained
  • Feb 2007 - Present
    Pharmacist Student / H. Lundbeck
    Stud.Pharm / H. Lundbeck A/S, Regulatory Affairs Operations, Denmark / 6 month work experience as part of education

Education

  • 1997 - 2009
    Danmarks Farmaceutiske Universitet
    Bachelor of Science in Pharmacy
  • 1993 - 1996
    Roskilde Tekniske Gymnasium
  • 1992 - 1993
    Odsherreds Efterskole
  • 1983 - 1992
    Fløng skole

Additional Information

Websites:
Personal Website
My LinkedIn
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