New webinar series: Basic know-how regulatory affairs
In a new webinar series the Centre for Digital Life Norway wants to give researchers basic knowledge on regulatory affairs. The webinars are tailored to researchers in the centre that ever plan to develop a drug or medical device. The two first webinars are focusing on medical devices. Free and open to all.
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
Next in the centre will develop webinars on drug development.