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.

Previous participants say:

• ”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”

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.

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

Instructors

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

• Helena Björkman, Pharma Relations
• Henrik Fant, Gedeon Richter
• Ifeoma Asiegbu, Merck Sharp & Dohme (Sweden) AB 
• Marianne Andersson, AstraZeneca R&D
• Emelie Bergman Perland, Läkemedelsverket
• Mahsa Rezaei, Läkemedelsverket

Time and venue

The course is held 26-28 Nov 2024 at Apotekarsocieteten, Wallingatan 26A in Stockholm, Sweden.

The course is also available as an online live-streaming course. Those who choose to attend online will have access to all streamed lectures for 1 month after the course date. 

Participation fee and registration

The registration fee is 18.000 SEK (approx. 1550 €) until 27th of October 2024 and thereafter 20.500 SEK (approx. 1760 €). The fee includes digital documentation and certificate, lunch and coffee/refreshments. Printed documentation can be obtained for an extra cost of 950 SEK (approx. 80 €). All prices exclude VAT.

Registration is done via Läkemedelsakademin's website.

If you want to participate online via streaming, register here: 

Registration - online streaming

If you want to participate on site in Stockholm, register here:  

Registration - onsite event in Stockholm

Other information

In order for us to offer all our participants the best possible quality, please register your application no later than 72 hours before the start of the activity. At short notice, please contact the project administrator for the activity via email.