New webinar series: Basic know-how regulatory affairs

The new webinar series on regulatory affairs is based on observed needs in the 35 transdisciplinary biotechnology projects in the centre.

– All drugs and medical devices must get regulatory approval before entering the market. Some of these rules and regulations that you will have to relate to, are useful to be aware of early on in the development process. The aim of the webinar series is to provide some useful basic knowledge of what to do and when. E.g. defining the product and intended use early on as well as getting acquainted with documentation and quality requirements may be useful to avoid unnecessary detours, says coordinator for innovation and industry collaboration in the centre, Beate Rygg Johnsen.

Two-part webinar on regulatory affairs and medical devices to start with

The centre has been in dialogue with the Norwegian Medicines Agency about the need for a webinar series on this topic. At the two first webinars we are focusing on medical devices which is relevant to for example projects working on in vitro diagnostics or decision support in precision medicine. We have hired the contract research organisation (CRO) LINK Medical Research AS to give researchers basic insight into this field.

– In the first webinar we will look at the planning and homework a project has to do for a commercial project at an early stage. In the second webinar we look at how you build your documentation towards a successful approval, says Tore Gjørsvik, project director in LINK Medical Research, who is the speaker at both webinars. 

• See the programme and sign up for one or both parts of the webinar
  18 March 10–11 AM part 1: Defining and planning key steps
  25 March 10–11 AM part 2: The paperwork and requirements for documentation

Academic employees can access the recordings of the webinars by logging on to our webinar material webpage with their FEIDE user.

Next in the centre will develop webinars on drug development.