Learning objectives 
The course gives a comprehensive picture of Regulatory Affairs. After the course, you will have a broad knowledge of Regulatory Affairs and a platform for further development in the area.

Course outline 
The course days are structured around lectures and discussions – individually and in groups. 
From the program: • Regulation • The authority role • Regulatory Affairs role in pharmaceutical development • Development phases, from selection of substance to market authorisation approval • Approval Procedure • Product life-cycle management • Variations and line extensions • Market authorisation application: structure and content • Product information • Practical application and discussions

Instructors 
All lecturers have long experience from Regulatory Affairs in the pharmaceutical industry and/or authority.

Lecturers, in alphabetical order: 
Elin Svensson-Wallin, Läkemedelsverket 
Emelie Bergman Perland, Läkemedelsverket 
Henrik Fant, Gedeon Richter 
Helena Björkman, Pharmarelations 
Reyhane Rezai, Lobsor Pharmaceuticals 
Jimmy Cedervall, Läkemedelsverket 
Marielle Svensson, Läkemedelsverket 
Marianne Andersson, Former AstraZeneca R&D