Introduction to Regulatory Affairs in Drug Development

We follow carefully the development of covid-19 and adapt according to the recommendations of the authorities. If required this course will be provided as an interactive online course (via Zoom). For now we keep the possibility to join this course physically, with the option to join via live streaming/recording, see below for link.

When developing new pharmaceuticals, the key to success is to ensure that all regulatory requirements are met throughout every stage of the research and development work. Doing it correctly from the beginning will save You time as well as money, which is often the difference between success and failure! This course targets an up-to-date overview of current regulation and how to ensure sufficient regulatory documentation in all phases of a drug’s development, with focus on the early phase.

Who should attend?

The course is primarily aimed at you who work at a small to medium sized research based pharmaceutical company and need an overall knowledge of Regulatory Affairs. You might work as project manager, project team member, innovator and entrepreneur, academic researcher, drug developer or as business manager who work in a pharmaceutical R&D company.

Learning objectives

You will get an overview of Regulatory Affairs and an understanding of the regulatory requirements that you encounter during drug development.

Course outline

The course is structured around lectures. Participants are given the opportunity to submit questions prior to the course starting date. From the program:

Instructors

The instructors are senior experts within their field. There are representatives both from Regulatory Affairs in the pharmaceutical industry as well as from the Swedish Medical Products Agency.

Time and venue

The course is held at Apotekarsocieteten, Wallingatan 26A in Stockholm. Registration and breakfast starting at 8:30. The course starts at 09:00 and finishes at 17:00. The course is also available as online live-streaming course. Those who choose to attend online will have access to all streamed lectures for 1 month. To register to the online course, please follow this link: https://www.lakemedelsakademin.se/produkt/introduction-to-ra-in-drug-development-online/

Participation fee and registration

The registration fee is 5.100 SEK until 11 Sep 2020 and thereafter 6.500 SEK. The fee includes digital documentation, certificate in digital format, lunch and coffee/refreshments. 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.