Basics of Regulatory Affairs

This 3-days course is for you who need a broad and essential knowledge of Regulatory Affairs. Quotes from previous participants:
”The course gave a perfect overview of all areas that concern Regulatory”.
”The lecturers brought up several different aspects.”
”Nice and dedicated lecturers with extensive experience and expertise in their respective areas”.

Who should attend

The course aims primarily at you who are new in your role within Regulatory Affairs and need knowledge about current regulations, processing and documentation. This course is also suitable for you who have worked for a while within the area and want an update or confirm your knowledge and get an opportunity to exchange experiences with colleagues regarding practical application of current regulations and guidelines.

Learning objectives

This is a foundation course that gives a comprehensive picture of Regulatory Affairs. After the course, you will have broad knowledge of Regulatory Affairs and a platform for further development in the field.

Course outline

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

Instructors

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

Time and venue

The course is available as live streaming on 22-24 October 2019.
The course is also be 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/?lang=en

Participation fee and registration

The registration fee is 15.300 SEK until 22 September 2019 and thereafter 17.400 SEK. The fee includes digital documentation, certificate in digital format and the recorded lectures during one month. All prices exclude VAT.

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

Participant list

We usually share a list of participants during the course. Many participants request these lists when taking our courses and we see networking as an important part of the professional development. With reference to this, we assume that our participants have an interest in us sharing the list and the lawfulness of processing the personal data is therefore the legitimate interest. The lists contain first and last name and organization. If you do not want your name and organization to be included in the participant list, please notify the project administrator at the time of registration or as soon as possible. If you have questions regarding the participant list, you are welcome to contact the responsible project administrator.