Health Technology and Life Science R&D, 5 cr

Core content

• Product development process
• Product market fit
• Design thinking in R&D projects
• IPR issues
• Regulation and quality
• Proof-of-concept and relevance
• Clinical trials
• Project and process management
• Manufacturing (CMC) considerations

Complementary knowledge

• Goal is to provide insights to the medical technology product as well as drug development process. The participants will understand the basic principles and key elements required in developing new products and drugs.
• Goal is to provide understanding how the markets and unmet needs affect the R&D in life science and the importance of product market fit. The participants will understand the how to assess and explore product market fit and how the information is applied in R&D process.
• Goal is to provide introduce design thinking principles and especially how these can be applied in efficiently life science R&D projects. The participants will understand the how, where and when to apply design thinking principles.
  
• Goal is to provide understanding of intellectual property rights and their protection. The participants will understand the basic mechanisms of IP protection and how these affect the life science R&D and business.
• Goal is to provide basic information related to regulatory and quality issues affecting the medical technology product and drug development processes. The participants will understand which authorities and regulations affect the R&D and how these should be taken into account in development process.
• Goal is to provide basic information of proof-of concept and relevance in R&D. The participants will understand the importance of POC and POR.
• Goal is to provide understanding of clinical trial process as part of the life science R&D. The participants will understand different phases of pre-clinical and clinical trial process as well as how these affect the whole R&D process.
• Goal is to provide understanding of importance of project and process management in life science R&D. The participants will understand different phases and methods related to project and process management.
• Goal is to provide insights to manufacturing related to the life science R&D. The participants will understand how the manufacturing affects the whole R&D process.