Regulations and Innovation Management in Life Sciences


M. Maffeis (former GlaxoSmithKline Verona)

F. Ledda (University of Trento)

M. Senigalliesi, M. Cevese (HIT – Hub Innovazione Trentino)

The aim of the course is to provide participants with the basis for understanding the main regulatory and management processes leading research and development (R&D) in the Pharma and Biotech Industry. 

To achieve this goal, in addition to the regulatory frameworks governing the R&D processes in Pharma and Biotech companies, the course will also cover the importance of intellectual property protection, project management and information management to generate valuable innovation in R&D, as well as the analysis of exemplary case studies.

Upon successful completion of this course, participants should:

  • Understand and describe the key steps in the R&D process in the Pharma and Biotech Industry
  • Describe the role of the main health authorities and regulation frameworks in the Pharma and Biotech Industry
  • Explain the role and relevance of intellectual property protection and management to create value from the innovation process, with particular focus on the Pharma and Biotech Industry
  • Recognize and recall the main databases and online tools to retrieve and manage scientific and patents information·   Acquire experience on specific case studies in biotechnology management and business fields.