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Classmates
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.
Welcome to the Clinical Product Development Course! In this 5-week online course, you will explore various aspects of clinical product development, including determining a safe and informative starting dose for First-in-Human trials. Whether you work for a multinational pharmaceutical company, biotech start-up, university, university medical center, medical research ethics committee/institutional review board, or regulatory authority, gaining a solid understanding of clinical product development will enhance your daily work. This hands-on course includes assignments based on real-world R&D projects, using teaching case studies to provide a practical and engaging learning experience.
With a blend of internationals with both scientific and industry backgrounds, the course has started to spread its wings. This online course is for post-graduate biomedical and pharmaceutical researchers working in academia, industry and at regulatory bodies and others who are interested in the (clinical) development of medicinal products.
Learning outcomes
After completing this course, you will:
- have a basic understanding of the process, challenges and costs of medicinal product development, from discovery, to (non-)clinical development and market approval;
- have insight into the scope of the authorities' guidelines for clinical development
- have a basic understanding of the different project valuation calculations: (risk-adjusted) Net Present Value (NPV) and the Real Option bases question-based approach;
- master the Questions Optimizer Calculator tool for defining the most optimal development route;
- be able to identify the most important questions, the uncertainties and costs for clinical development and estimate the potential after successful development.
Reserve sufficient time to study
To be successful in this course we recommend that you reserve at least 7-8 hours per week for this course. The course material for the next week is made available every Monday. You can work through this material at your own pace. However, we do recommend that you follow the rhythm of the course as much as possible. In other words, try to complete the week's course material before a new course week starts.
Take part in the conversation
At the bottom of each page you’ll find a chat box, where you can leave a note for your course mentor or engage in discussions with your fellow participants. At certain times during the course, you will be asked to write a text on a particular issue or use the chat box to discuss key concepts.
Subtitles in videos
Most videos in this course are close-captioned with English subtitles. To display the subtitles, simply click the “CC” button 
in the video player. You can also download the spoken text of the video by clicking the button ‘Download texttrack’. The button is displayed under the video. The downloaded file has an .vtt extention and can be opened in MS-WORD.
Self-assessments, assignments, and the chat box
During the course, you will be asked to answer self-assessment questions, give your opinion in a poll, download documents, and/or engage in an online discussion by reflecting on your fellow participants’ assignments. Importantly, the self-assessment scores are not recorded; rather, they are used simply for your convenience and to determine whether you understand the materials presented. As mentioned above, you can use the chat box at the bottom of each page to leave a personal note for your instructor or engage in discussions with your fellow participants.
Additional and Background information
Some topics will include Additional reading. You will need to read the information in this section for a good understanding of that particular topic. The Background reading is optional (but highly encouraged) and is provided in case you would like to learn more.
Video calls
We realize that reading and understanding texts regarding abstract or highly-specialist issues can be challenging, and you may have questions after studying the teaching material. To help answer your questions we offer three video calls with your mentor Marcel Kenter. The first videocall is in week 1 and used to get to know the group and we will briefly demonstrate how to navigate on the learning platform. The second videocall is in week 3 and is a Q&A session. In the Q&A sessions, you will have the opportunity to discuss your questions with Marcel together with your fellow participants. To ensure the Q&A session is productive, we will need to receive your questions by email at least one day before the session starts. And finally, in week 5 the final video call is scheduled where you can ask anything about the online exam and questions about the last weeks of the course. You can find the dates and times of the video calls in the course Dashboard. If you add them to your calendar, you will have the MS Teams URL's where the video calls can be found. To participate in the Q&A session you will need a laptop, desktop, or tablet with a webcam, microphone, stable internet connection, and a quiet location. Before you sign-in to the session, make sure you’re familiar with the MS Teams software.
Publications and reading materials
Throughout the course, we will provide relevant publications and others reading materials. Most documents can be read using the online pdf viewer, and when possible a downloadable pdf version will be available. Note that due to confidentiality agreements with our course contributors, some materials may not be downloaded and can only be viewed in the online pdf viewer; however, if a downloadable version is available, you will find it beneath the pdf viewer.
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.