Basics of Regulatory Affairs

Are You looking for broad and essential knowledge of Regulatory Affairs? Our popular 3-day course in fundamental Regulatory Affairs in English is back!

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 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:

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:

Andreas Dillner........................................ Läkemedelsverket

Emelie Bergman Perland………………………..Läkemedelsverket

Henrik Fant…………………………………………… Scientific Solutions

Ifeoma Asiegbu........................................ Merck Sharp & Dohme (Sweden) AB

Ingrid Paulsson......................................... Merck Sharp & Dohme (Sweden) AB

Jimmy Cedervall………………………...............Läkemedelsverket

Kristina Anfält………………………………………..Läkemedelsverket

Lisa Ersson................................................ Läkemedelsverket

Marianne Andersson................................ AstraZeneca R&D

Marie Gårdmark...................................... RegSmart Life Science

 

Time and venue

The course is held 11-13th of October 2022 at Apotekarsocieteten, Wallingatan 26A in Stockholm.
Schedule will be announced later.

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. To register to the online course, please follow the link here.

Participation fee and registration

The registration fee is 16.000 SEK until 12th of September 2022 and thereafter 18.200 SEK. The fee includes digital documentation and certificate, lunch and coffee/refreshments. Printed documentation can be obtained for an extra cost of 500 SEK. All prices exclude VAT.

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.