In a new webinar series the Centre for Digital Life Norway wants to give researchers basic knowledge on regulatory affairs for akademia in Norway. The webinars are tailored to researchers in the centre that ever plan to develop a drug or medical device. The centre has been in dialogue with the Norwegian Medicines Agency to develop the webinar series and LINK Medical have been hired in to hold this webinar series. The two first webinars are focusing on medical devices.
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.
When: Mar. 18 & 25, 2021
Time: 10:00 AM–11:00 AM, Zoom
Where: Oslo Norway
Know-how webinars on regulatory affairs:
Basic principles medical devices
- 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
Registration deadline: 11 March
All who register will get the link to the webinar a couple of days before the event.
The webinars will take you through the basics of regulations and quality requirements when you are developing a medical device, and tell you what you need to get started.
You will learn about:
- Defining the product properly
- Identifying the regulations and standards you need to comply with
- The roles of the various bodies you need to involve
- The key steps in a medical device development project
- We will answer some general questions from the participants at the end of the webinar, but questions that are specific for individual projects, will be answered to the participants individually after the event.
See the program and registration form on https://www.digitallifenorway.org/events/