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Who are your classmates and where are they from? Add a picture to your profile and it will appear here. In the course you will have a chance to introduce yourself and to chat with your fellow participants.
In this 5-week online Futurelab course, you are introduced to the world of authorities, regulatory affairs ad market approval for novel medical interventions. You will learn to identify the product claims that require approval and the way to structure an approach towards authorities to obtain and maintain market approval for a medical product.
Authority approval is mandatory at various milestones in the development of your novel biomedical intervention and need to be passed to move your product to the market and beyond. Topics that will be addressed are: What are the principles of authority approval procedures? How do you translate the target product characteristics (claims) to a dedicated market approval strategy? In addition, you will learn how to find regulatory information and to deduce the aspects relevant to accelerate the market approval process in pre-approval, market approval and post-approval stages. Finally, we will address the authority landscape (e.g. EMA, FDA, Notified bodies, EFSA), legislation, regulatory dossiers, authority advice meetings, product labels and approaches for device-drug combinations and other novel/complex products that require a tailored market approval approach.
As you have noticed this learning environment is pretty straightforward. Although we take great care to ensure the learning environment works on all browsers, Explorer may give suboptimal results (especially in video quality). Chrome, Safari or Firefox are recommended.
You can go back and forth in the course using the
buttons in the blue header of this learning environment. The next button is only active if all assignments of the topic are completed. The 
button in the header allows you to view the available course content at any time including reference to the topics you have already covered. At the bottom of each screen, you will find a 
button which enables you to ask for help -either with technical issues or course content related. You will be joined by other online course participants allowing you at specified times to interact and learn from each other. Use the 
button in the footer if you want to exit the learning environment.
During the course, you will at times be prompted to answer some self-assessment questions, perform and upload assignments and/or engage in online discussion by reflecting on your fellow learners assignment results. The scores of the self-assessments are not recorded. The self-assessments are included in this course for you conveniences to test if you comprehend the presented course content.
All videos in this course can be viewed with English subtitles. Press the CC button 
in the videoplayer to acces them. Some videos provide to option to naigate between chapters. Press this button 
to open the menu with all chapters. You will see each chapter marked as a dot on the videotimeline too.
Feel free to contact us by using the button in case you run into either technical problems or have course content related questions or issues.
This demo includes the course outline and several topics. Please have a look to see our learning platform and the way we like to teach online.
Activity
In the full course, you will see messages from your course instructor, uploaded assignments and comments from your fellow course participants.