About the course

Are you looking for broad and essential knowledge of Regulatory Affairs? Pharmaca's partner Läkemedelsakademin organizes a popular 3-day course in fundamental Regulatory Affairs which gives you a comprehensive picture and is a platform for your further development in the area. The course is given in English.

Who should attend?

This course is perfect if you are new in your role within Regulatory Affairs and need an overview of current regulations, processes and documentation. It also suits you who hold more experience within the Regulatory Affairs field and are looking to update or confirm your knowledge. In addition, it's an opportunity to exchange experience and best practices with colleagues regarding e.g. practical application of current regulations and guidelines.

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.

"The course gave a perfect overview of all areas that concern RA"
"The possibility to follow the course online, worked really well"
"Nice and dedicated lecturers with extensive experience and expertise in their respective areas"

Course instructors

Henrik Fant
Gedeon Richter

Helena Björkman
Pharma Relations

Reyhane Rezai
Lobsor Pharmaceuticals AB

Marianne Andersson
Former AstraZeneca R&D

Lecturer from the Swedish Medicines Agency to be announced later.

Course outline

The course days are structured around lectures and discussions – individually and in groups. From the program:

• Overview of European regulations
• 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

Upcoming course

Date: Dec 2–4

Price:
19800 SEK, early registration fee before October 27
22 550 SEK, late registration fee after October 27
Price excluding VAT

Venue: Stockholm/Online

Language:  English

Registrations terms

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