• Registreringsafdelingens rolle i virksomheden
• Lægemiddellovgivning i EU
• EU og dets institutioner
• Hvordan får man et lægemiddel registreret i EU?
• Hvilken slags dokumentation indeholder en registreringsansøgning?
• Produktinformation
• Vedligeholdelse af en markedsføringstilladelse
• Kliniske afprøvninger
• Pharmacovigilance
• Lægemiddelregistrering i USA
• Workshops
Download program
Kursusleder:
Anne Vinding Sillemann
Head of Global Regulatory Affairs, Topotarget A/S, Danmark
Undervisere:
Helen Maria Shennan
Regulatory Affairs Director, AstraZeneca A/S, Nordic, Danmark
Maiken Gy Kongstad
Senior Regulatory Affairs Manager, International Regulatory Affairs, Product Development, Nycomed: A Takeda Company
Marianne Toft
Director, Regulatory Operations & Information, Nycomed: A Takeda Company, Danmark
Kirsten Brønnum-Hansen
Afdelingsleder, New Products - NCE, LEO-Pharma A/S, Danmark
Lars Hyveled
Regulatory Lead (Development Projects), LEO Pharma A/S, Danmark
Vibeke Bjerregaard
MSc Pharm, Regulatory Product Manager, Novo Nordisk A/S
Lene Havsteen
Regulatory Coordinator, Sundhedsstyrelsen
Merete Schiegelow
M.Sc. Pharm., B. Medicines, B. Business, M. Communication, Director of Regulatory Policies and Intelligence, Novo Nordisk A/S