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Basics of Regulatory Affairs

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Are You looking for broad and essential knowledge of Regulatory Affairs? Our popular 3-day course in fundamental Regulatory Affairs in English is back again – and of course open for Swedish speaking participants as well! Also possible to join via live streaming if that suits You better.

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 with more experience within the Regulatory Affiars field, who 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.

    Time and venue

    The course is available for live streaming on 3-5 November 2020 at Apotekarsocieteten, Wallingatan 26A in Stockholm. Registration and breakfast starting at 08:45 on November 3:rd. The course start at 09:15 and finishes at 16:15 on November 5:th. The course is also available as a face-to-face course in Stockholm. To register to the course in Stockholm, please follow this link: https://www.lakemedelsakademin.se/produkt/basics-of-regulatory-affairs-4/

    Participation fee and registration

    The registration fee is 15.700 SEK until October 1, 2020 and thereafter 17.900 SEK. The fee includes digital documentation, certificate in digital format and the recorded lectures during one month after the live course. Printed documentation can be obtained for an extra cost of 500 SEK. All prices exclude VAT.

    Other information

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

    Inlägget Basics of Regulatory Affairs dök först upp på Läkemedelsakademin.


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