Basics of Regulatory Affairs

26 - 28 Nov 2024 Stockholm/Online

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 Affiars field and are looking to update or confirm Your knowledge. In addition, it's an opportunity to exchange experience and best practises 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.

Elin Svensson-Wallin.................Läkemedelsverket
Emelie Bergman Perland..........Läkemedelsverket
Helena Björkman.........................Pharma Relations
Henrik Fant.....................................Gedeon Richter
Ifeoma Asiegbu.............................Merck Sharp & Dohme (Sweden) AB 
Jimmy Cedervall............................Läkemedelsverket
Marianne Andersson...................Former AstraZeneca Director
Marielle Svensson........................Läkemedelsverket

Time and venue

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

The course is also available as an online live-streaming course. To register to the online course, please follow the link.

Participation fee and registration

The registration fee is 18.000 SEK until 27th of October 2024 and thereafter 20.500 SEK. The fee includes digital documentation and certificate, lunch and coffee/refreshments. Printed documentation can be obtained for an extra cost of 950 SEK. All prices exclude VAT. If you choose to pay with creditcard the zipcode in the registration-formula need to be five digits.

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. For information such as cancellation policy, participant list, GDPR etc – see “Registration Terms” to the right.

Want even more regulatory competence?

Build your life science and regulatory affairs expertise with our longer program: Regulatory Affairs Academy